Clinical Research Directory

CADASIL Disease Discovery

Cerebral autosomal dominant arteriopathy with subcortical infarct (CADASIL) is a lethal disease caused by a gene mutation that affects arteries in the brain. Symptoms include migraines, strokes, memory loss, and dementia. There are no treatments. Researchers want to study people who have CADASIL to learn more about it. Objectives: To learn more about CADASIL by studying people who have it. Eligibility: People ages 18-100 who were diagnosed with CADASIL in the past 5 years and can make their own decisions Design: Participants will be screened in another NIH protocol. Participants will have 3 visits over 2 years. These may include: * Physical exam * Thinking and concentration tests * Blood tests * Skin biopsy: A small skin punch is removed from the arm or leg * Eye exam and eye imaging tests * Fluorescein angiogram: A catheter is placed in an arm vein. Dye is given through the catheter and travels to the eyes. * EndoPAT: A small clamp on the fingertip measures blood volume. * Cardio-ankle vascular index (CAVI): Artery stiffness is tested with blood pressure cuffs on the arms and legs. Soft electrodes on the skin measure heart signals. * Brain MRI or MRA: They lie on a table that slides in and out of a tube that takes pictures. They may get a contrast agent in their vein. It brightens the brain so researchers can see where blood flows. * CT scan of the heart: They lie on a table that slides in and out of a machine that takes pictures. * They get contrast dye injected through a catheter. They may get a medicine that makes their blood vessels bigger or slows their heart rate.

Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality

This prospective, parallel-group randomised controlled trial evaluates whether cognitive-behavioural therapy for insomnia (CBT-I) improves arterial function and psychological and cognitive outcomes in hypertensive patients with poor sleep quality. Adults aged 18-70 with controlled hypertension and poor baseline sleep quality (sleep efficiency \<=85%) are randomised 1:1 to CBT-I (four weekly 60-minute sessions) or passive sleep education. The primary outcomes are change from baseline in pulse wave velocity and central arterial pressure at 12 months. Secondary outcomes include blood pressure, depressive symptoms, perceived stress, cognitive complaints, and sleep quality, assessed at baseline, 1, 6, and 12 months.

Natural History Study of CADASIL

Background: CADASIL (cerebral autosomal dominant arteriopathy with subcortical infarct and leukoencephalopathy) is a genetic disorder. It causes narrowing of the small blood vessels and can lead to strokes and dementia. Researchers want to monitor people with CADASIL over time. Objective: To learn more about how CADASIL affects a person s blood vessels over time. Eligibility: Adults ages 18 and older who have CADASIL, and healthy volunteers. Design: Participants will be screened with a medical record review. Participants will have 4 study visits over 9 years. Visits will last 6 8 hours per day, for 2 4 days. Participants will give blood and urine samples. They will have an electrocardiogram to record their heart s electrical activity. They will fill out a family tree. They will have tests that measure mental abilities like memory and attention. They may have a skin biopsy. They may have a lumbar puncture. Participants will have an eye exam. Their pupils will be dilated. They will receive a dye via intravenous (IV) line. Pictures will be taken of their eyes. Participants will have an imaging scan of their brain. They may receive a contrast agent via IV. Participants blood flow and blood vessel flexibility will be measured. In one test, a probe will be pressed against the skin of the their wrist, neck, and groin. In another test, they will hold one arm still while a microscope makes videos of the blood flow through a fingernail. In another test, they will perform light exercise or other activities while wearing an elastic band around their head or probes placed on their arm or leg. Healthy volunteers will complete some of the above tests.

Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers

The ACE Trial, funded by the National Institute on Ageing/National Institutes of Health (NIH), is a multicenter clinical trial. The ACE Trial will determine if taking the dietary supplement Equol could slow the progression of stiffening of the arteries, small blood vessel disease in the brain and memory decline. Equol is a soy-based supplement that has plant estrogen-like compounds in it. Equol is a metabolite of soy isoflavone. Our studies in Japan and other studies suggest that Equol may slow mechanisms related to memory decline. No previous studies in the United States have tested the effect of Equol on these mechanisms or memory decline. Supplementation of Equol in the ACE Trial is approved by the Food and Drug Administration (FDA). Researchers at the University of Pittsburgh, Pittsburgh, Pennsylvania, Wake Forest University, Winston-Salem, North Carolina, and Emory University, Atlanta, Georgia, are recruiting participants. The ACE Trial will ask participants to complete 7 clinic visits over a two-year period. The participants are asked to take Equol tablets daily for 24 months. Clinic procedures include Pulse Wave Velocity (to measure arterial stiffness), Magnetic Resonance Imaging (MRI) of the brain and tests of awareness and thinking.

High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Adults With HIV

This is a single site, randomized exercise trial with individuals at least 50 years of age living with HIV who experience suboptimal cognition. The overall goals of this proposal are to determine whether 16 weeks of structured high-intensity interval training (HIIT) can overcome vascular and cognitive impairments (Aim 1) to a greater extent than continuous moderate exercise. Additionally, investigator will seek to identify barriers to engagement in exercise and the participants' perceptions of the study and exercise interventions (Aim 2). This study will enroll 60 participants in Birmingham, Alabama. Data collection will occur at each visit, with baseline data collected at the initial visit with a 3-month follow-up occurring following completion of the intervention.

EndoVascular Aneurysm Repair: Heart Remodeling and Aortic Stiffness Study

Abdominal aortic aneurysm (AAA) is associated with a high burden of cardiovascular morbidity and mortality. Although endovascular aneurysm repair (EVAR) has become the preferred treatment for many patients with infrarenal AAA because of its lower perioperative risk, its impact on arterial stiffness and cardiac function remains insufficiently understood. Experimental and clinical evidence suggests that endograft implantation may increase aortic stiffness by reducing aortic compliance, potentially altering ventricular-arterial coupling and contributing to left ventricular remodeling and dysfunction. This prospective observational study aims to evaluate the effects of elective EVAR on aortic stiffness, left ventricular structure and function, and circulating biomarkers of myocardial stress and extracellular matrix remodeling. Patients with infrarenal AAA scheduled for elective EVAR will be assessed before the procedure and at 48 hours, 6 months, and 12 months after intervention. Aortic stiffness will be assessed using estimated carotid-femoral pulse wave velocity (cfPWV), while left ventricular function and remodeling will be evaluated by transthoracic echocardiography, including global longitudinal strain (GLS). Circulating NT-proBNP and MMP-3 concentrations will also be measured. The study will provide insight into the cardiovascular effects of EVAR and may improve understanding of procedure-related changes in arterial stiffness and cardiac remodeling, thereby supporting better long-term cardiovascular risk assessment and postoperative management in patients undergoing EVAR.

Predication of Arterial Stiffness in Healthy Adults by Oral Health and Chewing Assessments

INN.oral.HEALTH is an sub-study embedded in the Innsbruck Health Promotion Program (INN.HEALTH). The study investigates whether oral health, oral structure, and oral function provide additional information for understanding vascular health in adults from the general population. Cardiovascular and cerebrovascular diseases, such as heart attack and stroke, remain major causes of death and disability. Many risk factors, including blood pressure, blood lipids, blood sugar, smoking, physical activity, sleep, and diet, are already known to influence vascular health. However, oral health may also be related to vascular risk. Conditions such as tooth loss, impaired chewing, reduced tongue strength, or oral disease burden may reflect or contribute to general health and vascular ageing, but their additional value in prevention programs is not yet well understood. The main hypothesis of this study is that a standardized oral structure and function profile can improve the explanation of central arterial stiffness beyond established cardiovascular risk factors and lifestyle-related health metrics (INN.HEALTH study). Central arterial stiffness will be assessed using carotid-femoral pulse wave velocity, a marker of vascular ageing and cardiovascular risk. Participants will undergo a single oral assessment during Visit 4 of the INN.HEALTH study. The assessment includes screening of oral health status, dentition, bite force, tongue pressure, chewing efficiency, chewing and swallowing performance, questionnaires on oral health-related quality of life and food avoidance, and measurement of masseter muscle thickness. The study does not involve any treatment. The results may help clarify whether oral structural and functional markers can contribute to future vascular risk assessment and prevention strategies in the general adult population.

Effect of High-intensity Interval Training Combined With DASH Diet on Arterial Stiffness in Hypertensive Patients

Cardiovascular disease (CVD) is one of the leading causes of mortality worldwide and a major risk factor for morbidity worldwide . It is necessary to reduce the incidence and risk factors of CVD, as physical activity is known to reduce mortality from CVD. Arterial stiffness and hypertension are closely related in pathophysiology. Chronic high blood pressure (BP) can lead to arterial wall damage by mechanical stress, endothelial dysfunction, increased inflammation, oxidative stress, and renin-angiotensin-aldosterone system (RAAS) activation. HIIT has been shown to be equally or even better at stimulating health benefits than moderate-intensity continuous training (MICT) and is considered a time-saving aerobic exercise for reducing arterial stiffness in HTN patients

Cf-PWV and TyG Index Study

This study aims to investigate how metabolic health is related to arterial stiffness and daily blood pressure patterns. High blood pressure is one of the leading causes of heart disease worldwide, but cardiovascular risk is not determined only by average blood pressure values. Changes in blood vessel structure and metabolic function also play an important role in the development of cardiovascular disease. Arterial stiffness reflects how flexible or rigid the arteries are. It can be measured using carotid-femoral pulse wave velocity (cf-PWV), which is considered a reliable and widely used method to assess vascular health. Increased arterial stiffness is associated with aging and higher cardiovascular risk. At the same time, metabolic factors such as insulin resistance and central obesity are strongly linked to vascular damage. The triglyceride-glucose (TyG) index is a simple measure derived from routine blood tests and has been shown to reflect insulin resistance. Additional derived indices that combine TyG with body measurements (such as waist circumference and body mass index) may provide an even more comprehensive evaluation of metabolic risk. Another important aspect of cardiovascular regulation is how blood pressure changes throughout the day. Blood pressure naturally rises in the morning after waking, a phenomenon known as the morning blood pressure surge. When this increase is excessive, it has been associated with a higher risk of cardiovascular events such as stroke and heart attack. This study will evaluate the relationship between metabolic indices, arterial stiffness, and morning blood pressure patterns in adults undergoing ambulatory blood pressure monitoring as part of routine clinical care. The study will include both previously collected data and new participants evaluated using standardized methods. No additional interventions will be performed, and all data will be collected as part of routine clinical evaluation. The results of this study may help improve cardiovascular risk assessment by integrating simple metabolic markers with vascular measurements and daily blood pressure behavior, potentially allowing earlier identification of individuals at higher risk.

Carotid-Femoral, Oscillometric and Estimated Pulse Wave Velocity

What is the purpose of this research? This research aims to compare three different methods of measuring pulse wave velocity, which is the main parameter used for assessing arterial stiffness. This parameter is as important as blood pressure in predicting future cardiovascular risk. The investigators intend to compare carotid-femoral pulse wave velocity, which is the gold standard for measuring arterial stiffness, with brachial pulse wave velocity measured using a device similar to a blood pressure monitor and a mathematical formula validated in a large European population. Who is eligible for this survey? Anyone aged 18 or older who has been invited may participate, provided they sign an informed consent form. Where will the field research be conducted? The research will be conducted at a health center specializing in the treatment of hypertension. This center is a reference for outpatient blood pressure monitoring in the city of Uberaba (MG), Brazil. Patients enrolled in the study will also be included in the Hypertension Center of the Faculdade de Medicina de São José do Rio Preto (FAMERP). Which procedures will be performed by research participants? All participants who consent will answer some questions about their demographic and health information. A trained nurse will measure their weight, height, and blood pressure after a 5-minute rest, and then measure carotid-femoral pulse wave velocity. The participant will lie down on a bed and the nurse will place a sensor on the middle of their neck and the groin. The device will automatically deliver the parameters. At least three measurements are required for each participant. Measurements normally take between 10 and 15 minutes. Then, participants will wear a device to record blood pressure and pulse wave velocity for 24 hours. The nurse will fit the cuff around the participant's arm and attach the monitoring device to a belt around their waist. The device will take measurements every 20 to 30 minutes. 24 hours later, the participant must return to the research venue to have the equipment removed. What are the risks and adverse events of the procedures? There are no known risks or adverse events (AEs) associated with carotid-femoral pulse wave velocity measurements. The risks of this research are minimal, limited to discomfort during the AMBP recording, which occurs at a low frequency. However, excessive arm pain, allergic reactions, and edema may occur. To minimize these risks, a nurse will be available via telephone to aid all participants during the AMBP recordings.

Inflammatory Bowel Disease and Atherosclerosis Development

The study will show the influence of inflammatory bowel disease on the risk of development of atherosclerosis

Arterial Stiffness for Improved Prediction of Coronary Artery Disease by Coronary CT Angiography

This study will evaluate the ability of device-estimated pulse wave velocity and machine learning methods to improve the prediction of potential symptomatic coronary artery disease

Prebiotic Effects of California Grapes on Gut Health and Cardiometabolic Health in Overweight Men and Women

The goal of this clinical trial is to assess the impact of table grape consumption on gut microbiome, intestinal permeability, systemic inflammation, and vascular function in healthy overweight men and women aged 45-70 years. The main questions it aims to answer are: * Does daily grape intake alter intestinal microbiome composition and intestinal permeability? * Are changes in gut microbiota and intestinal permeability correlated with changes in cardiometabolic risk factors (inflammation, vascular function, lipid profiles)? * Does response to grape intake on gut microbiota, intestinal permeability, cardiometabolic and inflammatory markers differ between men and women? * Are metabolic pathways modified by grape consumption able to explain the link between gut health and cardiometabolic factors? Researchers will compare freeze-dried grape powder to placebo powder to see if grape powder improves cardiometabolic risk factors. Participants will * Consume the powder dissolved in water twice daily for 3 weeks * Follow their usual diet, modified to limit polyphenol-rich foods * Visit the clinic at the beginning and end of the intervention for vascular measurements and blood sample collection * Complete a 3-day 24-hour dietary recall and collect stool sample before each visit

Wild Blueberries for Gut, Brain, and Heart Health in Adults With High Blood Pressure

The purpose of the study is to determine the effectiveness of wild blueberries on cardiovascular health, cognitive function, and gut microbiota composition in non-Hispanic Black and White adults with elevated blood pressure.

Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Prediabetes

The goal of this clinical trial is to determine the effectiveness of using a freeze-dried wild blueberry powder on cardiometabolic health, cognitive function, and gut microbiota composition in adult women with prediabetes.

The Stroke Aetiology and VascuLar Disease in Stroke and TIA Study - A Clinical Study Analysing the Effects on Cardiovascular Health and Disease With an Extended Investigation Into Conditions Causative of Stroke and Concomitant Cardiovascular Disease in Patients Admitted for Acute Stroke or TIA

Annually, about 4000 Swedes suffer a recurrent stroke, and for many, their lives change dramatically. To prevent recurring strokes, knowledge about the individual's risk of recurrence is needed to tailor an effective preventive medical treatment. The purpose of the SALSA study is to investigate whether an expanded risk assessment and subsequent treatment can reduce the recurrence of stroke in study patients. Stroke, i.e., infarction/bleeding in the brain, has several different causes that individually or together constitute the risk of recurrence. Furthermore, stroke patients often have concomitant vascular diseases in other vascular beds, which further increases the risk. Every fourth patient with acute stroke or transient ischemic attack (TIA) admitted to any of the stroke wards at Danderyd Hospital, Stockholm, Sweden, is consecutively invited to participate in the SALSA study. Those who accept the study invitation, receive an expanded investigation of the most common causes of cerebral infarction (atherosclerosis, atrial fibrillation, narrowing of the brain\&#39;s small vessels) or brain haemorrhage (presence of the protein amyloid in the vessels, high blood pressure). Due to the high risk of stroke patients having a vascular disease, such as atherosclerosis, the presence of arterial stiffness in the aorta, 24-hour blood pressure, and blood circulation in the legs are examined at the follow-up visit. If vascular disease is detected, expanded preventive treatment is provided. Neither a general investigation of the most common stroke aetiologies in addition to the one assessed to have caused the current stroke nor examinations of other vascular beds are recommended in national stroke guidelines. In addition to the extended risk assessment, the patient will get a written treatment program tailored after the individual patient's risk profile. The compliance to this treatment program will be assessed during a return visit one year after the hospital stay. After this visit, the active participation in the study is completed for the study participant. During the remainder of the follow-up, the study participant will be followed in national medical registers. The remaining 3/4 of patients at Danderyd Hospital constitute the comparison group, who are investigated and treated according to routine and hence do not undergo the additional vascular examinations. Stroke recurrence and other cardiovascular events occurring within the next 5-10 years will be compared between study patients and the comparison group via the national stroke registry containing all stroke and TIA patients at Danderyd Hospital.

The Effect of Lipoprotein (a) on Arterial Stiffness, Endothelial Function and Myocardial Deformation

1. Introduction Lipoprotein(a), or Lp(a), is a type of lipoprotein that is structurally similar to LDL (low-density lipoprotein) but carries an additional protein called apolipoprotein (a). 2. Purpose of the Study The primary purpose of this study is to investigate the effect of Lp(a) levels on arterial stiffness, endothelial function, and left atrial (LA) and left ventricular (LV) deformation over a 12-month follow-up period. Secondarily, the study will investigate: * a) The incidence of major adverse cardiovascular events (MACE), including cardiovascular death, acute myocardial infarction, and acute stroke. * b) The correlation between MACE incidence and parameters of arterial stiffness, endothelial function, and LA/LV deformation. * c) The levels of oxidative load markers. 3. Materials and Methods This observational study will include adults aged 18-75 years (regardless of gender) who visit the outpatient clinics of the 2nd University Cardiology Clinic at "Attikon" General Hospital. All participants will sign a consent form. A full medical history, clinical examination, and blood collection will be performed to determine levels of Total Cholesterol, LDL-C, HDL-C, triglycerides, and Lp(a) at each visit.. Participants will be divided into three groups: * Group A: Lp(a) ≥50 mg/dL with Total Cholesterol\<200 mg/dl * Group B : Lp(a) \<50 mg/dL. with Total Cholesterol\>200 mg/dl * Group C (Control): Lp(a) \<50 mg/dL. with Total Cholesterol\<200 mg/dl At each group n ≥ 100 participants are anticipated. Measurements at baseline, at 6 and at 12 months: * Arterial Stiffness: Determination of carotid-femoral pulse wave velocity (cf-PWV) using the Complior SP device and 24-hour pulse wave analysis with the Mobil-O-Graph device. * Endothelial Function: Measurement of the endothelial glycocalyx thickness of sublingual capillaries using a Sidestream Dark Field (SDF) camera (GlycoCheck). This is expressed through the perfused boundary region (PBR) index. * Cardiac Deformation: Use of two-dimensional strain (speckle tracking) to calculate the Global Longitudinal Strain (GLS) of the LV and LA strain. * Oxidative Load: Determination of malondialdehyde (MDA) and protein carbonyls (PCs) levels as markers of oxidative stress using spectrophotometric kits. Statistical Analysis: Comparisons regarding the changes in these markers over 6 and 12 months will be conducted between the three groups.

The InterVitaminK Trial - Effects of Vitamin K Supplementation on Cardiovascular, Metabolic, and Bone Health

The purpose of this study is to examine the effect of menaquinone-7 (MK-7) supplementation on cardiovascular, metabolic, and bone health.

Empagliflozin Reversal of Arterial StiffnEss in Aging

Randomized placebo-controlled clinical trial in a cohort of males (n=40) and females (n=40), 60-80 years of age, with the hypothesis that SGLT2 inhibition with empagliflozin (10mg/day for 12 weeks) reduces aging-related arterial stiffening.

Arterial Stiffness in Individuals With Breast Cancer

The aim of this study was to evaluate vascular toxicity induced by anthracyclines and other anticancer drugs and to measure arterial stiffness in women with breast cancer and, in addition, to evaluate the acute and chronic arterial stiffness responses of upper extremity aerobic exercise training.

Effects of Cross-sex Hormone Therapy on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System

Current study aims to characterize five highly interconnected physiological systems in patients undergoing cross-sex hormone therapy - namely glucose and lipid metabolism, energy balance, eating behavior, functional brain networks involved in the regulation of eating behavior and the cardiovascular system - to gain novel insights into the effects of sex hormones on the human body. Gathered information will help to identify pathophysiological mechanisms for the development of overeating/obesity, insulin resistance, and cardiovascular disease. Secondarily, the relationships between the gut and oral microbiomes and metabolomes and circulating bacterial signatures will be investigated in relation to the other pervasive physiological systems. Current study is an observational study. The decision if the patient's request for cross-sex hormone therapy can complied with (i.e., if cross-sex hormone therapy is medically indicated) is made prior to the first contact with the study center and with the outpatients clinic for Endocrinology at the University Hospital in Leipzig. Decision ifor treatment is made according to national and international guidelines. Treatment of study participants with testosterone and estradiol/antiandrogens is not affected by the study. During the course of the study no invasive interventions are being performed.

Use of Dapagliflozin in Primary Prevention of Cardiotoxicity of Anthracycline Chemotherapy in Breast Cancer Patients

The goal of this randomized, double-blind, placebo-controlled clinical trial is to determine whether dapagliflozin, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, can help prevent anthracycline-induced cardiotoxicity caused by anthracycline chemotherapy in adult women with breast cancer receiving (neo)adjuvant treatment. The main questions the study aims to answer are: i) Does dapagliflozin reduce the decline in left ventricular function (measured by LVEF, GLS, and myocardial work) during and after anthracycline therapy? ii) Does dapagliflozin lessen the deteriorating effect of chemotherapy on endothelial function and arterial stiffness? iii) Does dapagliflozin effect levels of cardiac injury and inflammation biomarkers (e.g., hs-troponin T, NT-proBNP, ST-2, GDF-15, galectin-3, IL-6, MPO)? Researchers will compare dapagliflozin 10 mg daily with placebo to see whether those receiving dapagliflozin experience less heart and vascular impairment during treatment. Participants will: * Take either dapagliflozin or placebo once daily during anthracycline chemotherapy. * Undergo heart and vascular ultrasound, and a 6-minute walk test before chemotherapy and again at 24 and 52 weeks. * Provide blood samples before, during and after chemotherapy to measure cardiac biomarkers. * Complete multiple questionnaires on quality of life.

Vitamin K2 Supplementation in Adult Episodic Migraine

Migraine is a debilitating illness and a major cause of disability in the world. It is highly prevalent, especially among women. Vitamin supplementation is a potential therapeutic option for migraines that remains largely under-explored. Several studies have shown that people with migraine tend to have higher arterial stiffness than people without migraine. Vitamin K2 deficiency is an important mediator of arterial stiffness and calcification due to decreased carboxylation of matrix Gla protein (MGP). Supplementation reverses these changes and improves vascular health in patients with end stage renal disease according to previous studies. Therefore, vitamin K2 supplementation could serve a potential role in migraine patients. The purpose of the study is to test the effect of vitamin K2 on decreasing the frequency of migraine attacks and decreasing arterial stiffness. The population will be recruited from the neurology clinic at LAU Medical Center-Rizk Hospital and will constitute of adult patients. They will be randomized to receive either the supplement of vitamin K2 or a placebo for the duration of 6 months. Laboratory tests and arterial stiffness measurements will be done at the beginning, middle, and at the end of the study for comparison.

Fisetin to Improve Vascular Function in Older Adults

This is a pilot clinical trial to test the efficacy of intermittent treatment with the flavonoid compound fisetin for improving vascular endothelial function and reducing aortic stiffness in older adults. This trial will also determine the potential mechanisms by which fisetin may improve vascular function, including by decreasing mitochondrial oxidative stress, cellular senescence and senescence-associated secretory phenotype (SASP) factors in circulation. Lastly, safety, tolerability and adherence of fisetin treatment will be assessed.