Clinical Research Directory

Cilostazol for Prevention of Recurrent Stroke Trial

The goal of this clinical study is to learn if adding a medicine called cilostazol to usual treatment can help prevent another stroke, a heart attack, or death in patients who had a stroke caused by a blocked blood vessel, or a "mini-stroke" (also called a TIA), in the past 6 months. To determine if cilostazol is safe and effective at lowering the chance of strokes, heart attacks and deaths, the study will compare cilostazol to a placebo, a pill that looks the same as cilostazol but has no medicine in it. Participants will: * Be assigned by chance to take either cilostazol or a placebo, along with their usual medicine. * Not know which one they are taking, and neither will the study team, which keeps the results fair. * Be followed for up to 5 years to see if they have a stroke, heart attack, or major bleeding.

Clinical Investigation of the Cardioprotective Effect of Early Administration of SGLT2 in Patients Presented With AMI

This study aims to investigate the effect of early administration of DAPA during ischemia and before pPCI on infarct size, reperfusion injury-related myocardial damage, cardioprotection from HF, and renoprotection from AKI in patients with AMI.

TOP-CABG Trial: Follow-up Extension (TOP-CABG FE)

To further evaluate the long-term effects of the two antiplatelet strategies on saphenous vein graft patency, long-term adverse cardiovascular events, and bleeding events after coronary artery bypass grafting (CABG), we plan to conduct an extended follow-up study based on the previously completed TOP-CABG trial. This extended follow-up aims to provide high-quality evidence to inform more optimized and individualized long-term antiplatelet management strategies for patients after CABG.

Acute Kidney Injury Genomics and Biomarkers in TAVR Study

In the last decade, transcatheter aortic valve replacement (TAVR) has become an increasingly utilized alternative procedure for replacing a stenotic aortic valve. This study collects clinical information, DNA, blood and urine samples (throughout procedural hospitalization) in order to investigate the incidence of acute kidney injury (AKI) in patients undergoing TAVR and to identify key clinical and procedural predictors of AKI. This study seeks to identify blood and urine biomarkers that can be used for early detection of AKI around the time of the procedure. The study seeks to assess for novel genetic variants associated with development of AKI after TAVR. Finally the study seeks to assess for novel genetic variants and biomarkers that are associated with adverse cardiovascular events after TAVR and to further explore how these events may inter-relate with acute kidney injury.

Effectiveness of Digital Cardiac Rehabilitation on Functional Capacity in Patients With Myocardial Infarction

The goal of this clinical trial is to learn if a digital health-supported cardiac rehabilitation program works to improve functional capacity, adherence, quality of life, and psychological status in cardiac patients. It will also learn about the effect of digital health support when added to conventional outpatient cardiac rehabilitation. The main questions it aims to answer are: Does a digital health-supported cardiac rehabilitation program improve functional capacity? How does digital health support affect patients' adherence to cardiac rehabilitation? How does the program affect patients' quality of life and psychological status? Researchers will compare digital health-supported cardiac rehabilitation combined with conventional outpatient cardiac rehabilitation to conventional outpatient cardiac rehabilitation alone to determine whether digital support improves functional, behavioral, and psychological outcomes in phase II cardiac patients. Participants will: Be randomly assigned to receive either digital health-supported hybrid cardiac rehabilitation in addition to conventional outpatient cardiac rehabilitation or conventional outpatient cardiac rehabilitation alone. Have their functional exercise capacity assessed using the Six-Minute Walk Test (6MWT) as the primary outcome measure. Complete assessments to evaluate cardiac rehabilitation adherence and engagement, health-related quality of life, and psychological status. Have resting heart rate and blood pressure monitored as part of the clinical assessment. Participants in the digital health-supported group will also use digital health tools for activity monitoring, exercise adherence, reminders, education, communication, and weekly telecoaching.

Does OCT Optimise Results of Stenting on the Left Main Stem

The DOCTORS-LM study will investigate the impact of using optical coherence tomography (OCT) to guide the procedure in angioplasty of lesions of the left main stem responsible for myocardial ischemia.

Evaluation of a Remote Behavioural Stress Recovery Intervention for Myocardial Infarction Patients Younger Than Fifty-five (BRIM-55): A Feasibility Study

The goal of this feasibility study is to learn if the randomised controlled trial evaluating the Remote-delivery Balance in Everyday Life (rBEL) programme for adults younger than 55 years who have experienced a myocardial infarction (MI), is feasible. The objective is to examine the feasibility of the rBEL programme and the associated study procedures before a controlled evaluation of the programme. This is an uncontrolled, single-arm, pre-post treatment designed study. Participants of the target population will take part of the six session over 13 week programme. Feasibility will be evaluated against predefined feasibility criteria regarding study procedures and programme acceptability.

Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction

This study is open to adults with ST elevation myocardial infarction (heart attack) undergoing primary percutaneous coronary intervention (PCI). The purpose of this study is to determine whether a medicine called Xolatryp is safe and effective in improving cardiac outcomes. One dose of Xolatryp will be tested in this study. Participants are put into two groups randomly, which means by chance. One group receives a single 6-hour continuous intravenous infusion of Xolatryp and one group receives placebo. Participants are in the study for about 30 days. Placebo infusion looks like Xolatryp but do not contain any medicine. Participants are followed up via telephone and there is one visit to the study site on day 30. Heart health is assessed based on the analysis of blood samples, which are collected at the study site, via electrocardiogram (ECG), echocardiogram and cardiac magnetic resonance (CMR) imaging. At the end of the study, the results are compared between the two groups. During the study, the doctors also regularly check the general health of the participants.

DAN-RELEASE - Reconsidering Long-Term Aspirin in the Elderly Patients With Stable Ischemic Heart Disease

DAN-RELEASE is a national, randomized, registry-based trial including 7,000 participants in Denmark. The trial aims to determine whether discontinuation of long-term aspirin therapy is non-inferior to continued aspirin therapy in older adults with stable ischemic heart disease. Long-term aspirin therapy is recommended for patients with established ischemic heart disease. However, among clinically stable patients years after percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or myocardial infarction (MI), the evidence supporting lifelong aspirin therapy is limited. At the same time, the risk of serious bleeding increases with age. DAN-RELEASE will therefore compare aspirin discontinuation with continued aspirin therapy in adults aged 65 years or older with stable ischemic heart disease who have remained free from ischemic events for at least two years. The trial will assess whether discontinuing aspirin is non-inferior to continued treatment with respect to cardiovascular and bleeding outcomes.

Barts Revascularisation Registry

Despite the year-on-year decrease, coronary artery disease (CAD) still remains one of the leading cause of mortality worldwide. With advances in technology and our understanding of cardiac disease, we can now treat CAD using minimally invasive interventional techniques. This has revolutionised treatment for and improved the lives of many patients with CAD. Although trials have assessed various therapeutic strategies in various populations, real-world evidence of intervention and medical treatment among patients with CAD is increasingly recognised as an important part of providing safety and efficacy data and improving the care we provide. This data will add to that literature by assessing the characteristics and outcomes of patients with CAD. It will also identify and characterise predictors of outcomes, improve risk stratification and diagnostic evaluation.

Time for a Diagnostic Paradigm Shift From STEMI/NSTEMI to OMI/NOMI

The investigators hypothesize that occlusion myocardial infarction(MI)/non-occlusion MI approach to MI treatment will better predict acute coronary occlusion on coronary angiography, better limit infarct size, better preserve left ventricular function and result in lower long-term adverse cardiac events (all cause mortality, all cause rehospitalization) compared to standard ST-elevation/non-ST-elevation MI paradigm.

Reducing Blood Pressure in Patients With High Cardiovascular Risk

BP-REACH is a study of a team-based (pharmacist and health coach) program for lowering blood pressure for people with a prior stroke or heart attack in the Los Angeles Department of Health Services healthcare system. The goal of this clinical trial is to test if this team based program is better at helping people reduce their blood pressure than usual care for people with prior heart attack or stroke. The main questions it aims to answer are: * Do people in the REACH BP program have lower blood pressure at 12 months compared to those getting usual care? * Do people in the REACH BP program have better Life's Essential 8 scores and patient experience compared to those getting usual care?

Non-invasive Coronary Thrombus Imaging to Define These Cause of Acute Myocardial Infarction

We now have very sensitive blood tests that can pick up damage to the heart and find patients who have had a heart attack. However, whilst this is welcome, it does not identify what causes the heart attack and can sometimes pick up other conditions that cause a strain on the heart. The classic cause of a heart attack is when a blood clot forms on fatty deposits within the heart arteries. This leads to treating patients with blood thinning medication, and this is very effective and saves lives. However, many apparent heart attacks are not caused by blood clots and some may be caused by blood clots but pass unrecognised. In this proposal, we will test an exciting new imaging test that can 'see' from outside the body whether there is a blood clot in the heart arteries. This could provide a major new way of assessing patients to ensure they get the right diagnosis and the right treatment. This could ultimately improve the outcomes of or patients with heart attacks. We will recruit 80 patients in total who have recently been diagnosed with a heart attack from the cardiology department at the Royal Infirmary of Edinburgh. The research team will review patient's medical records to determine eligibility for the study. The research study involves participants undertaking the following research procedures and assessments: 1. A combined Positron Emission Tomography and Computed Tomography (PET-CT) scan of the heart 2. Ultrasound scan of the heart (Echocardiogram) 3. MRI scan of the heart 4. A blood test - a total of up to four tablespoons (60 mL) of blood will be taken for immediate testing and the remaining blood will be stored for future ethically approved studies 5. A follow up questionnaire 6 -12 months following the heart attack

Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland

Acute stress-induced (Takotsubo cardiomyopathy) presents like a heart attack and is triggered by intense emotional or physical stress. Although coronary arteries are unobstructed, it has been suggested that the risk of death is similar to a myocardial infarction. The purpose of the STARR study is to identify all cases of Takotsubo in Scotland since 2010 and assess its epidemiology and outcomes.

Barts Sex-CAD Database - Sex Hormones and Inflammatory Status in Coronary Artery Disease

There is a lack of understanding of how Coronary Artery Disease (CAD) - meaning the blocking or furring up of the arteries of the heart - starts and progresses in women. In both men and women, CAD is the most common cause of heart attacks, which occur when the blood supply in the heart is interrupted (these are also known medically as 'acute coronary syndromes'). Before the menopause women appear to be protected from CAD; however, after the menopause that protection is lost. Also, those women who do suffer a heart attack have twice the risk of further heart attacks compared to men despite having the same treatment that works well in men. Biological differences between men and women are probably playing an important role in the way CAD develops. However, due to a lack of research there is currently little understanding of how the female body works in this area. Inflammation is the body's natural response to injury or infection. Importantly it is also involved in the development of CAD. Hormones such as oestrogen and testosterone are also likely to be contributory factors. The investigators think the differences between the way these hormones and inflammation play a part in CAD in both men and women are important, but the role they play is not yet fully understood. In this study the investigators wish to measure the 'markers' of inflammation in the blood of patients attending Barts Heart Centre with chest pain. The investigators will also conduct questionnaires with these patients, to understand their hormone status and how parts of their medical history may be a contributory factor. For patients who have previously attended Barts Heart Centre will will contact them to conduct the questionnaire over the telephone only. The investigators will combine this data with the data that is routinely collected during hospital admission. In this way the investigators hope to understand whether inflammation together with hormone status plays an important role in CAD. Our hope is that through this research the investigators will address an under researched area and find new ways of treating women and men with coronary artery disease.

Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia

This study is being done to observe the effects of treatment from a device called the Bioboosti which utilizes pulsed electromagnetic waves on its ability to improve blood flow to the heart tissue in individuals with coronary artery disease (CAD).

Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar: The AGTP II Trial

The purpose of this trial is to evaluate the efficacy of a pericardial adipose graft transposition (Adipose Graft Trasposition Procedure, AGTP) for the improvement of cardiac function in patients with a chronic myocardial infarction. Preclinical studies in the porcine model of myocardial infarction have shown that the AGTP reduces infarct area and improves cardiac function. A first-in-man clinical (NCT01473433) trial showed that the AGTP is safe in patients.

MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation

Cardiac rehabilitation is a medically recommended program for patients with certain heart conditions. It includes exercise training, health education, and counseling. Unfortunately, many patients do not participate in cardiac rehabilitation. Some find it challenging to attend the in-person sessions. This study aims to compare two methods of delivering cardiac rehabilitation: in-person and through telehealth. The investigators want to know if the effects of these two programs are alike and if certain individuals benefit more from one program over the other.

HELicobacter Pylori Screening to Prevent Gastrointestinal Bleeding in Patients With Acute Myocardial Infarction

Background: Potent antithrombotic therapy has improved prognosis for patients with acute myocardial infarction (MI) significantly, however, at a price of increased bleeding risk. Helicobacter pylori (H. pylori) infection commonly causes upper gastrointestinal bleeding (UGIB). If systematic screening for H. pylori significantly reduces the risk of UGIB and improves outcomes is unknown. Study design: A cluster randomized, cross-over, registry-based clinical trial using nationwide Swedish registries for study population definition and data collection. Population: Patients discharged alive after hospitalization for acute type 1 MI at up to 40 hospitals across Sweden. Regional PCI networks comprise 18 clusters. Clusters will be randomized to routine H. pylori screening or no screening for 1 year after which cross-over to the opposite strategy occurs for 1 year. The study ends after one additional year of registry-based follow-up, one year after the end of the second period. Intervention: All MI patients will routinely be offered screening for H. pylori by urea breath test. Controls: Standard clinical practice. Data will be collected from SWEDEHEART and national registries. For patients testing H. pylori positive, eradication therapy will be prescribed at the caring physician's discretion. The individual implementation of H. pylori screening, test result and eradication therapy prescription will be recorded in SWEDEHEART. All follow-up data is collected from SWEDEHEART and national registries. Outcome: Primary outcome is UGIB defined as hospitalization or an outpatient visit in specialized care with ICD codes corresponding to UGIB. The secondary endpoints (in hierarchical) order: 1. Net Adverse Clinical Events (NACE): All-cause death, UGIB, hospitalization for MI, or hospitalization for ischemic stroke. 2. Major Adverse Cardiovascular and Cerebrovascular Events (MACCE): CV death, hospitalization for MI, or hospitalization for ischemic stroke. 3. All-cause death. 4. CV death. 5. Hospitalization for MI. 6. Hospitalization for stroke. 7. Hospitalization for HF. 8. UGIB requiring blood transfusion.

Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With STEMI

The study aims is to evaluate the efficacy and tolerability of L-Carnitine on biomarkers of myocardial reperfusion injury in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI by the assessment of nitrotyrosine as an oxidative stress marker and Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker

Management and Outcomes of Patients Admitted to Coronary Care Units, Depending on Degree of Frailty and Comorbidities

Background Patients less than 80 years of age, who suffer a myocardial infarction (MI) are usually (\>90%) offered an early invasive strategy including coronary angiography possibly followed by intervention, preferably percutaneous coronary intervention (PCI). Among non ST-elevation myocardial infarction (NSTEMI) patients, 80 years of age or over, only approximately 40% receive an invasive approach in Sweden, since the majority are handled in a conservative way, i.e. with medical treatment only. Furthermore, as with pharmacological treatment, there is a large variation between Swedish counties regarding the choice of strategy for the treatment of elderly (80+) patients with NSTEMI with an even larger variation between acute hospitals ranging from 20% to 90 %. The Swedish national guidelines for heart disease have emphasized that the patient's biological age, i.e. the patient's biological status and expected length of life, is crucial for decision-making. The Clinical Frailty Scale (CFS) is a global clinical measure of biological age, mixing co-morbidity, disability and cognitive impairment. The investigators have previously reported the potential importance of frailty for short-term (1 month) and medium-term outcome (1 year) in a NSTEMI population. However, published data on the role of frailty´s prognostic value, its capacity to predict adverse effects including complications, and the potential to guide clinical decision-making for elderly patients with myocardial infarction are scarce. Similarly, there is a lack of knowledge of how different patterns of comorbidity burden might influence rational decision-making. Aims To explore the association between frailty and treatment patterns in cardiac care To study the association between outcomes and degree of frailty, with and without comprehensive adjustment for differences in baseline characteristics. To study how treatment benefits for patients admitted to coronary care units differ in patients depending on comorbidities and frailty. Hypothesis The investigators hypothesize that frailty is independently associated with worse outcomes, including mortality, readmissions and complications. Methods and material An observational, register based, multicentre study. Inclusion criteria: Patients consecutively included in the Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART) registry. Exclusion criteria: None. SWEDEHEART is a national quality registry collecting information on all patients hospitalized with MI or suspected MI. All 72 Swedish hospitals with acute coronary care contribute with data. Briefly, information is collected prospectively about individual patients' medical history, treatment before admission, management during hospital stay, treatment at discharge, and diagnoses. Approximately 20.000 patients diagnosed with MI are included in this register per year. From January 1st 2020 frailty (CFS) is a mandatory variable in the registry. However, as a pilot project to ensure feasibility, five hospitals began to register frailty November 1st, 2017. For the investigators initial analyses data will be used from the pilot study to assess the association between CFS level and outcomes. The data extraction will be done by one of the monitors of the SWEDEHEART registry. After about two years the investigators will extract data prospectively entered into the registry. The frailty instrument The crucial study instrument CFS is a 9-point scale. It has good predictive validity and prognostic power, is relying on clinical judgment, and is relatively easily used in clinical practice. Since the scale includes several degrees it can be considered to be particularly appropriate for risk stratification, and accordingly it has been used for this purpose. The investigators have got the instrument owner´s permission to use this scale. The case record form (CRF) focus on demographic and clinical patient characteristics registered in the SWEDEHEART, particularly those which are supposed to be potential confounders when testing the hypothesis: chronological age, gender, cardiovascular risk, diabetes, heart failure, renal insufficiency, other co-morbidities, including the Charlson Comorbidity Index (CCI), previous MI, medications, ejection fraction, and the classification of MI. Cardiovascular risk will be assessed according to the Global Registry of Acute Coronary Events (GRACE) risk score (GRS). Results from echocardiography, ECGs, laboratory testing and registration of anthropometric data will be included according to routine practice within the frame of SWEDEHEART. Follow-up of cohorts of invasively or conservatively treated patients with different stages of frailty will be done one, three, six, 12, 24 and 36 months after the inclusion point respectively.

A Study of Microcirculatory Function in Type 2 Myocardial Infarction (T2MI)

The purpose of this research is to find out if patients with Type 2 Myocardial Infarction (T2MI) without significant epicardial coronary artery disease (CAD) have a greater chance of having coronary microvascular disease (CMD).

Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy

The primary aim of this study is to evaluate the efficacy and safety of novel P-CAB (tegoprazan 50 mg once daily) as compared with standard PPI (rabeprazole 20 mg once daily) for protection of GI events in patients with known cardiac and vascular disease receiving chronic use of antithrombotic drugs (either antiplatelets, OAC, and its combinations) who are at high GI bleeding risk. The primary hypothesis is that P-CAB (experimental arm) would non-inferior to PPI (standard arm) with respect to the rate of the primary composite end point of GI events at 12 months after randomization.

A Study of Population and Sex-specific Troponin Cutoffs for Ruling Out Acute Myocardial Infarction

Acute myocardial infarction (MI) is defined as a rise and/or fall in cardiac troponins (cTn) with at least one value above the 99th percentile upper reference limit (URL) in the context of symptoms or clinical evidence of myocardial ischemia. The URL is based on measurements in a healthy reference population. Currently, a sex-uniform manufacturer-provided 99th percentile URL of troponin is utilised at Danish hospitals as a diagnostic cutoff for acute MI for both men and women. Reportedly, healthy men have twofold the troponin level compared to healthy women, suggesting that the use of a uniform URL for troponins may lead to the under-diagnostication of acute MI in women and potentially over-diagnostication in men. The purpose of the DANSPOT study is to evaluate the clinical effect on diagnosis, treatment and outcomes in men and women presenting with acute MI of implementing international guidelines recommendations of sex-specific 99th percentile URLs for troponin into clinical practice. First, to determine the sex-specific 99th percentile URLs of troponins based on a healthy Danish reference population, blood samples from Danish blood donors were analysed using one troponin T assay and four troponin I assays. Second, the DANSPOT study is a nationwide cluster-randomised trial with a "stepped-wedge" design, with participation of all 22 Danish hospital laboratories and associated departments of cardiology. With one-month intervals, each of the 22 centres is randomised to shift from the presently applied uniform 99th percentile URL of troponin to our newly determined population- and sex-specific 99th percentile URL. Each patient is followed up for 12 months after their first troponin measurement during the index admission. The hypothesis of the DANSPOT study is that implementation of population- and sex-specific 99th percentile URLs for troponin will ensure that the right patients receive the right treatment. The investigators expect to detect significantly more women with acute MI, theoretically resulting in a more accurate diagnosis and treatment of women and men with acute MI.