Clinical Research Directory

Norwegian Danish Spontaneous Coronary Artery Dissection Exercise Study

The goal of this randomized clinical trial is to determine whether a supervised high-intensity interval training (HIIT) program can safely improve cardiorespiratory fitness and overall health in adults who have previously had spontaneous coronary artery dissection (SCAD), a non-atherosclerotic cause of heart attack that often affects younger women. Participants are women and men aged 18 years or older, with a confirmed SCAD at least 12 weeks before enrollment, who are medically stable, cleared for exercise testing, and able to attend supervised sessions. The main questions the study aims to answer are: * Does a 12-week supervised HIIT program lead to a greater improvement in cardiorespiratory fitness (measured as peak oxygen uptake (VO2peak, ml/kg/min)) compared with usual care, without increasing the occurrence of major adverse cardiovascular events (MACE)? * Is a 12-week HIIT program safe for people with prior SCAD, assessed by the occurrence of MACE? Researchers will compare two randomized groups (1:1): * Group A (HIIT): Participants take part in a supervised treadmill-based high-intensity interval training program twice per week for 12 weeks, with continuous heart rate monitoring and clear rules for stopping in case of symptoms. * Group B (usual care): Participants continue with the exercise advice they have already received after SCAD, without a structured supervised program and with a recommendation to avoid high-intensity exercise (above 85% of maximum heart rate). Participants in both groups will: * Undergo cardiopulmonary exercise testing (CPET) at baseline and after 12 weeks to measure VO2peak and blood pressure response during exercise. * Have blood tests (for example cholesterol and cardiac biomarkers), blood pressure, heart rate and weight measured. * Complete validated questionnaires on quality of life (World Health Organization Quality of Life-BREF (WHOQOL-BREF)), anxiety (Generalized Anxiety Disorder 7-item scale (GAD-7)), and depression (Patient Health Questionnaire-9 (PHQ-9)). * Have activity data recorded using the MIA activity-tracking app and heart rate data will be uploaded simultaneously from portable devices. Safety will be monitored continuously. Major adverse cardiovascular events (MACE), including death, recurrent heart attack (SCAD or non-SCAD), heart failure, stroke or transient ischemic attack, extracoronary arterial dissection, cardioversion or implantable cardioverter-defibrillator (ICD) therapy, will be recorded during the 12-week intervention and a 25-week follow-up period (total study duration per participant: 37 weeks).

CHIP in Health and Disease

Clonal hematopoiesis (CH), including clonal hematopoiesis of indeterminate potential (CHIP), is an age-associated condition characterized by the expansion of hematopoietic stem and progenitor cell clones carrying acquired somatic mutations. Although CH is associated with an increased risk of hematologic malignancies, its greater public health impact derives from its strong association with cardiovascular diseases, including coronary artery disease and stroke. Emerging evidence suggests that CH-associated mutations promote chronic inflammatory signaling in myeloid immune cells, thereby contributing to atherosclerosis and adverse cardiovascular remodeling. This observational translational study aims to characterize the biological spectrum of clonal hematopoiesis across different stages of disease risk and manifestation. Using state-of-the-art single-cell and multi-omics approaches, the study will compare inflammatory pathways, immune cell states, and mutation-associated molecular programs among healthy individuals without CH, individuals with high-risk CH, and patients with CH-associated hematologic or cardiovascular disease. The ultimate goal is to identify shared and disease-specific mechanisms linking clonal hematopoiesis to adverse clinical outcomes and to generate insights for future preventive, anti-clonal, and anti-inflammatory therapeutic strategies.

A MAajor RAdiation-based PCI Study in STEMI and NSTEMI

In France and Italy, approximately 240,000 percutaneous coronary angioplasties (PCI) are performed annually, with an increasing number of complex procedures, including those involving the left coronary common trunk, a bifurcation, chronic occlusion, or requiring Rotablator Rotary Atherectomy (ARota). The medical literature lacks sufficient data regarding several key aspects of complex angioplasty. These include the epidemiological characteristics of patients undergoing such procedures, the impact of irradiation delivered and the quantity of iodine injected on these lengthy procedures, their procedural complication rate, and in-hospital mortality.

Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease

This prospective, multicenter, open-label, superiority trial will enroll patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. Following successful percutaneous coronary intervention (PCI) of the infarct-related artery (IRA), patients who meet the eligibility criteria will be randomized in a 1:1 ratio to either in-hospital staged complete revascularization with PCI of non-IRA lesions performed on a separate day during hospitalization, at least 48 hours after PCI of the IRA, or out-of-hospital staged complete revascularization with PCI of non-IRA lesions performed after discharge between 15 and 45 days of randomization. In both groups, non-IRA lesions with 50-69% stenosis will be evaluated using FFR.

Smartphone Application to PREDICT Real-Time Cardiovascular Risk for Heart Attack and Stroke

To assess the diagnostic accuracy of a smartphone application in predicting heart attack or stroke within 3-4 days in high-risk patients.

The Rule-Out Acute Myocardial Infarction Using Aritifical Intelligence Electrocardiogram (ROMIAE) 2 Trial

This study is to see whether the AI ECG assisted protocol is as safe and efficacious as conventional protocol in early triage of suspected myocardial infarction.

Telegram Messenger Support for Smoking Cessation After Heart Attack

This randomized controlled trial will evaluate whether a 6-month behavioral intervention delivered via Telegram messenger increases smoking cessation rates in patients after myocardial infarction (MI). Adult smokers hospitalized with acute MI who regularly use Telegram will be randomly assigned to either: * INTERVENTION GROUP: Standard care plus a 6-month Telegram chatbot program providing personalized motivational messages, cognitive-behavioral techniques for craving management, and relapse prevention support. * CONTROL GROUP: Standard care (routine physician advice to quit smoking) plus basic surveys via Telegram without therapeutic content. The primary outcome is 30-day point prevalence abstinence at 6 months, verified by blinded telephone interview with participant and corroborating report from a close relative. Secondary outcomes include changes in cigarette consumption, nicotine dependence, motivation, and intervention engagement metrics. This study addresses the critical gap in smoking cessation support after hospital discharge and could provide evidence for a scalable digital health solution in cardiac secondary prevention.

Eccentric Exercise Rehabilitation After Myocardial Infarction

This clinical trial will evaluate a two-week eccentric exercise program conducted as part of comprehensive cardiac rehabilitation in patients after a heart attack (myocardial infarction). Eccentric exercise involves muscle contractions while the muscles are lengthening and may allow the muscles to work at a relatively high load with a lower cardiovascular and metabolic demand than traditional exercise. The main aim of the study is to determine whether eccentric exercise affects blood levels of proteins released or regulated in response to physical activity, including musclin, interleukin-6, and myostatin. The study will also evaluate whether the program improves physical performance and functional capacity. Participants will complete eccentric cycling exercise on a semi-recumbent cycle ergometer during a two-week cardiac rehabilitation program. Blood samples and physical-function measurements will be collected before and after the intervention.

Avatar-Based Serious Game for Cardiac Rehabilitation After Heart Attack

This study looks at whether a tablet-based education game helps people recover better after a heart attack. When people leave the hospital after a heart attack, they are usually given advice about their medicines, follow-up visits, cardiac rehabilitation, and warning signs to watch for. Many people find it hard to remember all of this information later at home. In this study, adults who were treated in hospital for a heart attack were divided by chance into two groups. One group received the usual face-to-face education before going home. The other group used an interactive avatar-based education game on a tablet, in which a guide character walks the patient through the same topics. The game could also be used at home for one month after discharge. The researchers measured how much patients knew about their heart disease, their quality of life, whether they attended cardiac rehabilitation, and whether they were readmitted to hospital. These were checked before discharge and again at 1, 3, and 6 months. The goal is to learn whether the avatar-based game helps patients understand and manage their condition better than usual education.

GSI Cardiac on Revolution Apex - US

The goal of this clinical data collection study is to collect raw CT scan data using a new GSI Cardiac mode on GE HealthCare's Revolution Apex CT system. Two groups of participants will be enrolled: A) Participants scheduled to undergo a Coronary CT Angiography (CCTA) as part of their standard of care B) Participants scheduled to undergo a cardiac catheterization or have a history of heart attack Participants in Group A will: -Have a standard of care CCTA immediately followed by a research GSI Cardiac scan Participants in Group B will: -Have a research CCTA immediately followed by a research GSI Cardiac scan Both groups will be in the study for approximately 1 day. There are no follow-up visits after the day of scan.

Health Coaching for Patients With Cardiovascular Disease

For patients discharged with a diagnosis of cardiovascular disease coronary artery disease resulting in myocardial infarction and/or congestive heart failure, this study will evaluate if the addition of 12 virtual health coaching sessions over the course of 16 weeks will improve physiological, psychological, and social health outcomes, prove acceptable and satisfactory for these patients with CVD, decrease CVD-related questions and concerns sent to the provider via MyChart, and reduce hospital readmission rates over a 90-day period as compared to patients discharged with the same diagnosis who receive standard post-discharge care. The study will also evaluate the perceptions of physician and advanced practice providers related to the health coach as part of the interprofessional team and the amount of time spent addressing CVD-related patient questions and concerns via MyChart messages.

Mannitol Administration for Delerium Prevention

The aim of the study is to evaluate the efficacy of adjuvant administration of mannitol for the prevention of delirium in patients with myocardial infarction.

Abbreviated Antithrombotic Therapy After PCI in Patients With AF and AMI

The aim of the study is to compare clinical outcomes between direct oral anticoagulant (DOAC) monotherapy versus dual antithrombotic therapy (DOAC plus clopidogrel) in patients with atrial fibrillation and acute myocardial infarction after percutaneous coronary intervention (PCI).

ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY

Although advances in treatment and patient management have considerably improved post-infarction prognosis, the risk of sudden cardiac death remains a major concern. Sudden cardiac death (SCD) is defined as an unexpected death occurring within one hour of the onset of symptoms, often of arrhythmic origin. In patients who have survived a myocardial infarction, sudden death represents a persistent threat. This risk is often associated with complications such as left ventricular dysfunction, malignant ventricular arrhythmias, and structural alterations of the myocardium, all of which can favor the development of fatal cardiac events. Among the risk factors identified, reduced left ventricular ejection fraction, a history of ventricular arrhythmias and the presence of extensive scarring of the myocardium are particularly significant. Assessing the risk of SCD in post-infarction patients is crucial to determining appropriate prevention strategies, such as implanting automatic implantable defibrillators (ICDs). Assessment tools are varied, but currently only left ventricular ejection fraction (LVEF) \< 35% is identified and validated. However, this risk stratification is unsatisfactory, particularly in view of SCD in patients with a history of myocardial infarction and a moderately impaired LVEF (between 35 and 50%). Although the initial treatment of myocardial infarction is essential for the patient's immediate survival, managing the risk of sudden death in the long term remains a major clinical challenge. A multiparametric approach is needed to optimize prognosis and prevent premature death in these patients.

BEAT-SHOCK Registry

This regulation defines the purpose, the operational processes, and the organization of the registry BEAT-SHOCK (Basel Evaluation of Acute Therapy in cardiogenic SHOCK). It describes the requirements for collecting, storing, processing, managing and sharing health-related registry data.

Can Wearable Technology be Used to Predict Exercise Intensity

There is a knowledge gap in the literature around using watts to measure exercise intensity in walking and running, this is largely due to new technological developments. Whereas the relationship is widely recognised and used for cycling in elite to clinical populations. While the relationship breathing rate and exercise intensity is well established, this are no guidelines using breathing rate as a physiological measure of intensity. New technology may aid to bridge these gaps. The main aims of the study are: - Can the relationship between oxygen uptake and watts during incremental exercise Can breathing frequency be used to determine aerobic exercise intensity The participants will complete two 9 minute incremental accredited exercise tests on the flat around cones and on treadmill at the given speed of walking around the cones. The test will stop at 6.8kph or at participant volition.

The Impact of Audiovisual Structured Patient Education Material in Improving Clinical and Behavioural Outcomes in Home-Based Cardiac Rehabilitation Programme Participants

The goal of this clinical trial is to find out if newly developed, culturally adapted educational videos-sent through a mobile messaging app-can help people with coronary heart disease do better in a home-based cardiac rehabilitation program in Malaysia. The main questions it aims to answer are: * Do the educational videos help participants improve their fitness? * Do the videos help participants better understand heart health and stick to a healthy lifestyle? Researchers will compare the educational videos to existing standard educational materials to see if the video-based education is more helpful for supporting rehabilitation at home. Participants will: * Take part in a 12-week home-based cardiac rehabilitation program * Receive either educational videos or standard education materials * Meet with the cardiac rehabilitation team every 4 weeks * Complete a treadmill exercise test, blood tests, and questionnaires before and after the program.

Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells

The primary goals of this study are to compare the differences in tissue-resident Treg gene signature for activation, proliferation, and suppressive function using single-cell/-nucleus RNA sequencing in patients treated with ld-IL-2 compared to control grouped by individual tissue beds from in and around the heart. Additionally, tissue-resident Tregs will be compared to peripheral blood Tregs from the same patient to assess the differential effect of ld-IL-2 on the two compartments.

Ticino Artificial InTelligence integrAtioN for Occlusion Myocardial Infarction

The goal of this clinical trial is to evaluate whether an artificial intelligence (AI)-based ECG interpretation tool improves the early diagnosis and treatment of occlusion myocardial infarction (OMI) in adults presenting with suspected acute coronary syndrome (ACS) who do not meet traditional ST-elevation myocardial infarction (STEMI) criteria. The main questions it aims to answer are: 1. Does AI-assisted ECG interpretation enable more timely identification and treatment of OMI, as defined by earlier initiation of coronary intervention? 2. Does AI-assisted diagnosis reduce infarct size, measured by peak high-sensitivity troponin T (hsTnT) levels? Researchers will compare AI-assisted ECG interpretation to standard care to determine if the AI tool improves clinical outcomes and care timelines. Participants will: 1. Present with symptoms suggestive of ACS but without clear STEMI criteria 2. Be randomized 1:1 to either AI-assisted or standard ECG interpretation 3. Undergo follow-up assessments for cardiovascular outcomes, including 30-day death, time to treatment of total coronary occlusion, and peak hsTnT levels

Clinical Echocardiography and S' Wave for Early Recognition of Acute Coronary Syndrome in the Emergency Department, A Prospective Study

The goal of this prospective observational study is to assess the diagnostic accuracy of the tissue Doppler imaging (TDI) S' wave in detecting acute coronary syndrome (ACS) in adult patients presenting to the emergency department (ED) with acute chest pain. This study focuses on patients aged 18 years or older, who require continuous cardiac monitoring but do not show ST-elevation myocardial infarction (STEMI) on their initial ECG. The main questions it aims to answer are: * Can TDI S' wave velocity serve as an early diagnostic marker for ACS in the emergency department? * How does the diagnostic performance of TDI S' compare with other echocardiographic markers (MAPSE, TAPSE, and diastolic parameters such as E, E', A, E/A, E/E')? * Do demographic factors (age, sex, BMI, echogenicity) influence the diagnostic accuracy of echocardiographic parameters for ACS? If there is a comparison group: Researchers will compare TDI S' wave velocity findings with the final adjudicated diagnosis of ACS (determined after 3 months) to evaluate its sensitivity and specificity.

Dual Antiplatelet Therapy Strategies After Acute Myocardial Infarction Undergoing PCI: Prasugrel vs Ticagrelor & 12 Months vs 1-3 Months

This study is testing different blood-thinning treatment strategies for people who have had a heart attack and were successfully treated with a coronary stent procedure (PCI). All strategies tested are already approved for this condition and used inversally. This study will define which of the approved strategies is the best one. After PCI, patients usually receive two antiplatelet medicines for up to 12 months to help prevent another heart attack or stroke, but this treatment can also increase bleeding risk. This study will compare a shorter course of dual antiplatelet therapy followed by one antiplatelet medicine alone versus the standard 12-month course. In addition, the study will compare two commonly used antiplatelet drugs, prasugrel and ticagrelor. The goal is to find out which strategy best prevents death, heart attack, or stroke while minimizing serious bleeding. This study is not testing any new intervention, rather comparing approved drugs and approved durations of use.

Timing of Coronary Angiography in NSTEMI Complicated by Acute HF

Study objectives: To determine the optimal timing of coronary angiography (CAG) in patients with non-ST-segment elevation myocardial infarction (NSTEMI) complicated by acute decompensated heart failure (AHF). The primary objective of this trial is to test the hypothesis that immediate CAG ≤2 hours after establishment of NSTEMI diagnosis would result in a significant reduction in primary composite outcome of death from any cause, non-fatal myocardial infarction (MI), or hospitalization for heart failure (HF) at 12 months after randomization as compared with delayed CAG after stabilization. Study hypothesis: Immediate CAG ≤2 hours after establishment of NSTEMI diagnosis would result in a significant reduction in primary composite outcome of death from any cause, non-fatal myocardial infarction (MI), or hospitalization for heart failure (HF) at 12 months after randomization as compared with delayed CAG after stabilization. Background: Although current guidelines recommend early CAG within 2 hours for patients with NSTEMI complicated by AHF, many patients with NSTEMI complicated by AHF did not receive early CAG. However, no randomized clinical trials have evaluated the optimal timing of CAG in patients with NSTEMI complicated by AHF. Therefore, the investigators aimed to perform a prospective, investigator-initiated, open-label, muilticenter trial to compare the efficacy and safety between immediate CAG (CAG \<2 hours after establishment of NSTEMI diagnosis) and delayed CAG after stabilization (i.e. improved dyspnea and disappearance of pulmonary congestion) in participants with NSTEMI complicated by AHF. Study procedure: Following the establishment of NSTEMI diagnosis, participants fulfilling the eligibility criteria will be randomized at a ratio of 1:1 to immediate CAG ≤2 hours after randomization or delayed CAG after stabilization on another day during hospitalization.

Aspirin Continuation or Interruption in Patients at Moderate Risk for Cardiovascular Events Undergoing Colonoscopy and/or Polypectomy

One in 4 adults between 50 and 80 reports taking regular aspirin. The prevalence of aspirin uses increases with age as well as co-morbid vascular diseases. Patients with cardiovascular diseases are at risk of developing colorectal neoplasms. In patients undergoing screening colonoscopy, interruption of aspirin is believed to be associated with increased cardiovascular events. Continuation of aspirin can however be associated with an increased risk of post-polypectomy bleeding. International guidelines on periendoscopy management recommend the continuation of aspirin based on evidence from cohort studies, mostly retrospective, suggesting that the rate of bleeding is low. Cardiovascular complications from aspirin interruption can lead to disabilities and occasional deaths. The cardiovascular risks following aspirin continuation or interruption in endoscopy have not been well studied. There has been no randomized study to compare either strategy. Endoscopists are divided on their opinion on whether to stop or to continue aspirin. The proposed large randomized controlled trial (RCT) is powered to detect small differences in both outcomes. Findings from this RCT will address this important question and inform our clinical practice.

The Effect of Sodium Glucose Co-trnasportert Type 2 Inhibitors on Arterial Stiffness, Endothelial Glycocalyx Thickness and Cardiac Deformation After Acute Myocardial Infarction

Acute myocardial infarction (MI) remains one of the leading causes of cardiovascular morbidity and mortality worldwide. It most commonly occurs due to acute coronary artery occlusion following rupture or erosion of an atherosclerotic plaque and subsequent thrombus formation. Despite significant advances in reperfusion strategies and guideline-directed pharmacological therapy, patients who survive MI remain at increased risk for adverse cardiovascular outcomes, including heart failure, recurrent myocardial infarction, stroke, and cardiovascular death. Therefore, additional therapeutic strategies that may improve vascular function, myocardial remodeling, and overall cardiovascular prognosis following MI are of considerable clinical interest. Sodium-glucose cotransporter-2 (SGLT2) inhibitors have recently emerged as an important pharmacological class with significant cardiometabolic benefits. Large randomized clinical trials have demonstrated that SGLT2 inhibitors reduce the risk of hospitalization for heart failure and cardiovascular mortality in patients with type 2 diabetes mellitus and in patients with heart failure irrespective of diabetic status. The cardioprotective effects of these agents appear to extend beyond glycemic control and include improvements in myocardial energetics, vascular function, inflammation, and oxidative stress. Emerging evidence suggests that SGLT2 inhibitors may also exert beneficial effects on vascular stiffness, endothelial function, and myocardial remodeling. However, data regarding their potential impact on arterial stiffness, endothelial glycocalyx integrity, and myocardial deformation parameters in the early post-myocardial infarction setting remain limited. The primary aim of the present study is to investigate the effect of empagliflozin administration (10 mg daily) on arterial stiffness, endothelial glycocalyx thickness, and myocardial deformation indices of the left ventricle and left atrium during a 12-month follow-up period in patients presenting with ST-segment elevation myocardial infarction (STEMI). Secondary objectives include: 1. evaluation of the incidence of major adverse cardiovascular events (MACE), defined as cardiovascular death, recurrent myocardial infarction, and acute ischemic stroke; 2. investigation of the association between the occurrence of MACE and vascular and myocardial functional parameters, including indices of arterial stiffness, endothelial glycocalyx integrity, and myocardial strain measurements; and 3. assessment of oxidative stress burden through circulating biomarkers. This prospective observational study will include adult patients diagnosed with acute STEMI who are hospitalized in the Second University Cardiology Clinic of "Attikon" General Hospital. All participants will provide written informed consent prior to enrollment and will receive standard guideline-directed therapy for acute myocardial infarction according to the current European Society of Cardiology (ESC) guidelines. Participants will be allocated into two groups. Group A will include patients receiving empagliflozin 10 mg once daily, initiated either at hospital discharge in patients with concomitant type 2 diabetes mellitus or in patients without diabetes who present with reduced left ventricular ejection fraction (LVEF \<40%). Group B will serve as the control group and will not receive empagliflozin therapy. The anticipated sample size of the study is 80 patients, with approximately 40 participants in each group. Exclusion criteria include chronic kidney disease with estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73 m², active malignancy, autoimmune or autoinflammatory disorders, severe hepatic impairment, and pregnancy or breastfeeding. Participants will undergo detailed evaluation at baseline and at 3, 6, and 12 months. Arterial stiffness will be assessed through measurement of carotid-femoral pulse wave velocity (cf-PWV) using the Complior SP system, which represents the gold standard non-invasive method for evaluating large-artery stiffness. In addition, 24-hour pulse wave analysis will be performed using the Mobil-O-Graph device to obtain central hemodynamic parameters. Endothelial function will be evaluated through assessment of endothelial glycocalyx thickness in sublingual microvessels using Sidestream Dark Field (SDF) imaging with the GlycoCheck system. Glycocalyx integrity will be quantified by the Perfused Boundary Region (PBR) index, which reflects erythrocyte penetration into the glycocalyx layer and serves as a marker of endothelial barrier dysfunction. Cardiac structure and function will be assessed using two-dimensional speckle-tracking echocardiography. Global longitudinal strain (GLS) of the left ventricle will be calculated using the standard 17-segment model from apical views, while left atrial strain will be measured to evaluate atrial reservoir and contractile function, providing sensitive markers of myocardial remodeling after infarction