Clinical Research Directory

CRIC Combined With MFT for MFR in Patients With Incomplete Revascularization of CAD

The main objective of this study is to demonstrate whether the combination of chronic remote ischemic conditioning and mindfulness therapy can improve myocardial flow reserve in patients with incomplete revascularization of coronary artery disease.

Evaluating New Radiation Techniques for Cardiovascular Imaging

Title: Evaluating New Radiation Techniques for Cardiovascular Imaging Background: Cardiac CT angiography is associated with radiation exposure. Different methods of creating CT pictures have been developed to reduce the radiation dose to the subject. The purpose of this research study is to learn whether these low dose research imagings are accurate or predict subject outcomes. Cardiac CT is also used for diagnostic imaging of coronary artery disease and identification of abnormal cardiac structures. An additional purpose of this study is to monitor the progression of cardiac disease. Cardiac imaging software and AI are constantly evolving and requires validation for accuracy. Using existing scan data, updated image software reconstruction can be applied and compared to previous existing standard of care images. Objectives: \- To study new ways of taking pictures of the heart or blood vessels using computed tomography. Eligibility: \- Adults at least 18 years of age who will be having imaging studies to help detect heart or blood vessel problems. Design: * Participants will be screened with a physical exam and medical history. Blood samples will be taken to check kidney function. * Participants will have a CT scan of the heart and blood vessels. A contrast agent may be used to improve the quality of the images. The scanning session may last up to 2 hours. * Timing of and the need for follow up contact will depend on results from the initial scan and may be repeated to assess for late events. Telephone, office contact, or other follow-up of subjects may be done after CCTA to evaluate if the subject had subsequent cardiovascular testing. Further follow up will be based on reported test results.

Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions

Clinical research with medical devices indicated in accordance with the CE marking, led by researchers, multicenter, open, prospective, randomized and controlled. Patients are randomized to treatment with a conventional balloon and then a coronary stent or to initial plaque modification with Orbital Atherectomy (OA) and then a coronary stent. To evaluate the efficacy and safety of OA in the adequate treatment with coronary stent of the calcified bifurcation lesion using angiography and optical coherence tomography (OCT).

Multivessel TALENT

Multivessel TALENT is a prospective, randomized, multi-center study comparing clinical outcomes between SUPRAFLEX Cruz and SYNERGY in approximately 1550 patients with de-novo three vessel disease undergoing percutaneous coronary intervention (PCI). Patients will be treated according to "state of art PCI"; not only treatment strategies based on the latest ESC guideline, such as SYNTAX Score II recommendation, Heart Team discussion, post-procedure intravascular imaging optimization, cholesterol reduction by statin or PCSK-9 inhibitor, but also exploratory treatment strategies based on the latest evidence, such as physiological assessment using quantitative flow ratio and prasugrel monotherapy following 1-month dual antiplatelet therapy after PCI.

Postprocedural Contrast Mediated FFR Plus Intracoronary Infusion of Nitroglycerin in Multivessel Patients (PROMETEUS TRIAL)

the use of pressure wires is the standar of care to evaluate angiographically intermediate coronary lesions, however, limitations in the management of these type of lesions continue to be a challenge for the interventional cardiologist. The use of FFR has some limitations such as the use of adenosine due to its cost, adverse effects (e.g. transient atrioventricular block, angina, headache, etc.), time consuming and some relative contraindications for its use. In this sense, in recent years new rest indices (iFR, RFR, dPR) and hyperemic indices without adenosine (cFFR-NTG, Pd/Pa-NTG or cFFR) have been developed, demonstrating an improvement in terms of outcomes with its use, so they can also be used as a tool to guide us to plan our strategy. These new indices, particularly the cFFR-NTG, are simpler, at least as safe and have an excellent correlation with the FFR with adenosine in the assessment of intermediate coronary lesions. In recent years, functional assessment after intervention has also been increasingly implemented, which, like intracoronary imaging, can make us change our attitude and correlate with the prognosis. The lower implementation of this practice, especially in multivessel patients, may result from having to lose the position of the wire to check equalization, difficulty in crossing the wire, wear/breakage of the material after diagnosis (2-3 vessels), use more time and contrast, etc. These problems could be reduced, at least partially, with the use of the workhorse coronary guidewire pressure microcatheter to measure post-PCI functional assessment. Although the usefulness of post-PCI FFR has been demonstrated, there is no clearly established cut-off value (0.84-0.96) and it seems that in reality the values are a continuum of risk so that the higher the value, the better the prognosis . Furthermore, other simpler indices such as rest or hyperemic indices without adenosine have not been correlated with FFR in post-PCI. The purpose of this study is to evaluate the correlation between cFFR-NTG and other indices taking FFR as a reference in multivessel patients after undergoing intervention. Establish cut-off points and correlate it with adverse cardiovascular events (MACE) in a 1-year clinical follow-up.

ANGiographic Evaluation of Left Main Coronary Artery INtErvention

To assess if an angiographic follow-up at 6 months after Percutaneous Coronary Intervention in Left Main Coronary Artery Disease decrease the composite objective of death, myocardial infarction, and stroke at 36 months.

Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions

Significant coronary disease of the left main coronary artery (LMCA) is found in 4%-5% of all coronary angiography procedures. Classically, it has been determined that a significant angiographic stenosis should reach at least 50% of the vessel diameter by visual estimation, which corresponds to 75% of the vessel area. However, angiography has a number of limitations inherent to the technique and location of stenosis, and other techniques are therefore available for evaluation. Intracoronary ultrasound (IVUS) deserves, together with the pressure guidewire, special consideration in determining the severity assessment (anatomical and functional) of lesions in this location. Using IVUS the most commonly used cut-off value is 6 mm2. in ambiguous lesions of the LMCA, a MLA \>6 mm2 would indicate no revascularisation, a MLA \<4.5-5 mm2 would indicate revascularisation, and MLA values between 4.5-5 and 6 mm2 would make it advisable to use FRF/iFR to decide. Optical coherence tomography (OCT) is another intracoronary imaging modality, with greater resolution and significant differences from IVUS. no MLA cut-off point with OCT has been demonstrated for the management of LMCA lesions. Due to the differences in imaging with both techniques, the thresholds established as cut-off points in IVUS cannot be extrapolated to OCT. The objective is to compare the minimal luminal area by IVUS and OCT of angiographically intermediate LCMA lesions and to assess the prognostic value of TCFA assessed by OCT.

Cardiovascular Health Study (CHS)

To determine the extent to which known risk factors predict coronary heart disease and stroke in the elderly, to assess the precipitants of coronary heart disease and stroke in the elderly, and to identify the predictors of mortality and functional impairments in clinical coronary disease or stroke.

Coronary Artery Risk Development in Young Adults

To measure changes in coronary heart disease risk factors in cohorts of Black and White males and females 18 to 30 years of age at baseline. Also, to identify lifestyles during this age span which influence these changes in risk factors.

Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Trial

The study aims to compare a preventive percutaneous coronary intervention (PCI) plus optimal medical treatment (OMT) strategy vs. OMT for treatment of non-functionally significant non-culprit lesions presenting with optical coherence tomography (OCT) findings indicative of vulnerable plaque, in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease.

ISCHEMIA-EXTEND (Extended Follow-up)

The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) Extended Follow-up (ISCHEMIA-EXTEND) is the long-term follow-up of randomized, surviving participants in ISCHEMIA. ISCHEMIA was an NHLBI-supported trial that randomized 5,179 participants with stable ischemic heart disease to two different management strategies: 1) an initial invasive strategy (INV) of cardiac catheterization and revascularization when feasible plus guideline-directed medical therapy (GDMT), or 2) an initial conservative strategy (CON) of GDMT. The trial did not demonstrate a reduction in the primary endpoint with an initial invasive strategy. There was an excess of procedural myocardial infarction (MI) and a reduction in spontaneous MI in the INV group. Prior evidence suggests that spontaneous MI carries a higher risk of subsequent death than procedural MI. There was a late separation in the cardiovascular (CV) mortality curves over a median of 3.2 years follow-up in ISCHEMIA. The MI incidence curves crossed at approximately 2 years. However, during the trial follow-up phase there were excess non-CV deaths in the invasive strategy. Therefore, it is imperative to ascertain long-term vital status to provide patients and clinicians with robust evidence on whether there are differences between management strategies and to increase precision around the treatment effect estimates for risk of all-cause, CV and non-CV death over the long-term. Overarching Goal: To assess the effect of an initial invasive strategy on long-term all-cause, CV and non-CV mortality compared with an initial conservative strategy in SIHD patients with at least moderate ischemia on stress testing, over 10 years median follow-up. Condition: Coronary Disease Procedure: Observational Phase: Phase III per NIH Condition: Cardiovascular Diseases Procedure: Observational Phase: Phase III per NIH Condition: Heart Diseases Procedure: Observational Phase: Phase III per NIH

Mediators of Atherosclerosis in South Asians Living in America

South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians represent over one-quarter of the world's population, there are no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a longitudinal study of South Asians at three United States centers to identify risk factors linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of this study is to understand the causes of heart disease and stroke in South Asians and compare these causes to those in other United States ethnic groups.

Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)

This international, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) compared to dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients undergoing percutaneous coronary intervention (PCI) with the latest generation drug-coated balloon (DCB). The study includes patients with stable or unstable coronary syndromes and aims to assess rates of ischemic and bleeding adverse events.

Multi-Ethnic Study of Atherosclerosis (MESA)

The Multi-Ethnic Study of Atherosclerosis (MESA) is a study of the characteristics of subclinical cardiovascular disease and the risk factors that predict progression to clinically overt cardiovascular disease or progression of the subclinical disease (Bild DE et al., Am J Epidemiol 2002; 156(9):871-881). MESA consists of a diverse, community-based sample of an initial 6,814 men and women aged 45-84 years without known cardiovascular disease at baseline. Thirty-eight percent of the recruited participants were White, 28 percent African American, 22 percent Hispanic, and 12 percent of Chinese descent. Participants were recruited from six field centers across the United States: Baltimore City and Baltimore County, Maryland; Chicago, Illinois; Forsyth County, North Carolina; Los Angeles County, California; New York, New York; and St. Paul, Minnesota. Participants are being followed for identification and characterization of cardiovascular disease events, including acute myocardial infarction and other forms of coronary heart disease (CHD), stroke, and heart failure; for cardiovascular disease interventions; and for mortality. The first examination took place over two years, from July 2000 to July 2002, and has been followed by additional examinations. Participants have been contacted every 9 to 12 months throughout the study to assess and adjudicate clinical morbidity and mortality. The study was approved by the Institutional review boards at all participating institutions, and all participants gave written informed consent. In addition, informed consent was obtained for extensive data sharing (dbGaP) and genetic/omic studies, including candidate genes (NHLBI CARe), genome-wide scans (NHLBI SHARe), exome sequencing (NHLBI ESP) and, most recently, the NHLBI TOPMed program.

University of North Carolina Alumni Heart Study

To continue surveillance of the participants in the University of North Carolina Alumni Heart Study, which tests the hypothesis that hostility and related psychosocial factors are involved in the pathogenesis of coronary heart disease.

Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

This research is being done to evaluate the short term and long term effects of ketogenic diets on measures of cardiovascular health. Such measures include cholesterol levels, blood pressure, weight, and thickening of the blood vessel wall over time. Adults aged 18 or older who are already on a ketogenic diet for at least 12 months or who are interested in beginning on the modified Atkins diet may join.

Health Behavior Management Program for Patients With Coronary Heart Disease

Coronary artery disease (CAD) is a major chronic condition severely impacting population health in China. Our previous cohort studies revealed a high comorbidity rate between CAD and frailty, suggesting their interrelated equivalence as clinical syndromes with shared risk factors. In recent years, pilot integrated health management initiatives in China have demonstrated promising outcomes, yet evidence remains scarce regarding patients with concurrent CAD and frailty-a critical gap needing urgent resolution to achieve the "Healthy China 2030" strategic goals. Building on prior research, this project aims to systematically evaluate existing management models for patients with CAD and frailty, develop a tailored health management framework, and implement it in clinical settings through empirical studies. The model will be optimized according to regional and demographic variations, leveraging cardiac rehabilitation centers, exercise-based interventions, and internet-enabled technologies to enhance coordinated care. By improving exercise efficacy, mitigating frailty progression, and enhancing quality of life, this initiative seeks to establish a robust chronic disease management system. The findings will provide evidence for formulating regional health policy and insurance strategies in Anhui Province, ultimately improving standardized management rates for chronic diseases.

Risk Prediction of Disease Progression in Early-Onset Coronary Atherosclerosis

This study is part of a nationwide research project in China that aims to better understand how coronary artery disease develops and progresses in young adults. The study will enroll approximately 10,000 participants aged 45 years or younger who undergo coronary CT scans at multiple hospitals across China. Information collected at enrollment includes basic health information, cardiovascular risk factors, blood test results, medication use, lifestyle habits, and, for some participants, genetic data. Participants will undergo follow-up coronary CT scans after several years to evaluate changes in coronary artery plaque and disease progression. By analyzing these clinical and imaging data, the study aims to identify factors associated with disease progression and to develop prediction models that may help estimate an individual's future risk of coronary plaque progression and cardiovascular events. The results of this study may contribute to improved risk assessment and early prevention strategies for coronary artery disease in young populations.

IRIS- DESyne X2 in the IRIS-DES Registry

This study evaluates effectiveness and safety of DESyne X2 in Routine Clinical Practice.

Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice

The objective of this study is to evaluate effectiveness and safety of Xience Sierra stent in the "real world" daily practice as compared with other drug-eluting stents.

Evaluation of Effectiveness and Safety of Synergy XD and Synergy Megatron™ Stent

The objective of this study is to evaluate the effectiveness and safety of Synergy XD stent and Synergy Megatron™ Stent in the "real world" daily practice as compared with the other drug-eluting stents.

Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions

The objective of this study is to assess the safety and efficacy of the Freesolve resorbable magnesium scaffold (RMS) in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to the Xience coronary drug-eluting stent (DES) system

SECURE Trial: Stress Echocardiography With Carotid Ultrasound vs Routine CT Coronary Angiography in Chronic Coronary Syndrome for Endpoints

Diseases of the heart and circulation are known as cardiovascular diseases, and they cause over 160,000 deaths each year. Coronary heart disease (CHD) is the most common cardiovascular disease. This is due to a build-up of fatty material, known as atherosclerosis, in the blood vessels supplying blood to the heart muscle. This can cause chest pain or if blocked, can cause a heart attack. Two of the main non-invasive tests to look for coronary heart disease are Computed Tomography Coronary Angiography (CTCA) and Stress Echocardiography (Ultrasound scan). CTCA shows the arteries and allows small amounts of disease to be seen that may not yet be causing any symptoms. However, if there's lots of disease and calcification, it becomes difficult to tell how severe it is, which means several tests may be needed. Stress Echocardiography shows if enough blood is reaching the heart muscle, so can show if there is severe disease that needs treatment. However, it can't see the arteries so doesn't showt small disease that may benefit from tablet treatment. There is not yet an effective non-invasive combined test that can give all this information in one go. Studies have shown that if there's atherosclerosis in another artery, a person is very likely to have coronary atherosclerosis as well. Carotid atherosclerosis, in the neck arteries, can be seen with ultrasound similar to stress echocardiography. So, by combining these two tests the investigators want to see if it is possible to see severe as well as small areas of disease in one test, to provide better treatment. The study will enrol 2,000 participants, who need investigation for CHD, equally randomised to CTCA or stress echocardiography with carotid ultrasound. We will follow these participants for 5 years and observe for any adverse outcomes and ask them to complete a questionnaire.

Clinical Evaluation of Radiation Reduction for Optimized Safety

The primary objective of this study is to determine whether a reduced radiation protocol (RRP) in which angiograms are acquired at ultralow radiation doses and then processed using spatiotemporal enhancement software can produce similar quality angiographic images as compared with standard techniques.