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).

A Study Of Exercise In Patients With Spontaneous Coronary Artery Dissection And Fibromuscular Dysplasia

The purpose of this study is to assess the cardiopulmonary, hemodynamic, and symptom responses to acute bouts of varying intensity aerobic and resistance exercise in people with Spontaneous Coronary Artery Dissection (SCAD) and/or Fibromuscular Dysplasia (FMD).

Spontaneous Coronary Artery Dissection (SCAD) Avatar Study

The purpose of this study is to evaluate patient satisfaction, comfort, and trust in interacting with an avatar compared with speaking to a human clinician during a pre clinical visit.

Defining the Basis of Fibromuscular Dysplasia (FMD)

The purpose of this study has evolved and expanded since its inception. Originally the intent was to establish the functional, molecular and genetic profile of fibroblasts from Fibromuscular Dysplasia (FMD) patients as compared to carefully matched control subjects. While this remains among the objectives, the study has been expanded to undertake a fully powered cross-tissue systems genetics analysis of FMD, and now also the related arteriopathies spontaneous coronary artery dissection (SCAD) and cervical artery dissection (CvAD). The overall objective is to disclose the core biologic mechanisms of these disorders.

A Study to Analyze the Role of Sympathetic Nervous System in Spontaneous Coronary Artery Dissection

The purpose of this research is to compare sympathetic function (flight or fight system) and arterial health including structure and mechanics of participants with history of spontaneous coronary artery dissection (SCAD) to age and sex matched control participants.

Exercise Support and Rehabilitation for Patients After Spontaneous Coronary Artery Dissection

The study aims to examine the feasibility of a remote exercise program in women recovering from spontaneous coronary artery dissection (SCAD) events (heart attacks). Heart attacks caused by SCAD are different to the traditional heart attacks. In SCAD a tear happens within the blood vessels causing partial or full blockage. The population affected by SCAD is hugely different to the population affected by other 'traditional' heart attacks; as SCAD mainly happens in otherwise healthy women. From historical cases, SCAD has been associated with strenuous exercise, however, medical research did not find a link. The recovery after SCAD is also very different from other 'traditional' heart attacks. Cardiac rehab programmes are designed for an older population therefore they may not be suitable for a younger predominantly female population. This study will examine if a remote-exercise programme is achievable in people after a SCAD event.

International Spontaneous Coronary Artery Dissection (SCAD) "iSCAD" Registry

The aim of "iSCAD," the International Spontaneous Coronary Artery Dissection (SCAD) Registry, is to serve as an internationally collaborative, multicenter registry coordinated by an experienced and centralized coordinating center in an effort to increase the pace of participant recruitment, and thereby increase statistical power of studies related to SCAD. The ultimate goal of iSCAD Registry is to facilitate the development of best practices and clinical guidelines for preventing SCAD or its recurrence. This observational study will be prospective and retrospective in its recruitment and will collect clinical information to better understand the natural history and prognosis for SCAD.

Survey on Physical Activity and Qualify of Life in Fibromuscular Dysplasia

Fibromuscular dysplasia (FMD) is a disease of the arteries that is not due to plaque build-up or inflammation. While some patients with FMD are health, some may experience heart attacks, strokes, aneurysms or blood vessel dissection/tearing which can be life-threatening. It predominantly impacts women and younger patients. As a result of this diagnosis, many patients are counseled to restrict or avoid certain physical activities out of concern for provoking or worsening vascular complications. There are no guidelines or consensus recommendations regarding appropriate physical activity for patients with FMD. The lack of consensus may lead to confusion for patients and may negatively impact their quality of life. This study will conduct a large, national survey of patients with FMD to assess the type of physical activity restrictions and impact on quality of life and emotional well-being.

Genetic Investigations in Spontaneous Coronary Artery Dissection (SCAD)

The purpose of the research is to identify mutations (defects in the genetic blueprint) that cause spontaneous coronary artery dissection (SCAD), in other words, spontaneous tears in blood vessels that supply the heart. Some mutations may be inherited (passed on) from a parent without an apparent blood vessel problem while others may develop for the first time in the affected person.

Genetics of Spontaneous Coronary Artery Dissection (SCAD-INSPIRE Genetics)

Spontaneous coronary artery dissection (SCAD) is a rare cause of coronary ischemia and infarction where a tear in blood vessel wall either restricts the flow of blood or the blood becomes trapped in between the layers of the vessel causing the vessel to impinge on the lumen and causing an obstruction or restriction of blood flow. The ultimate goal of this proposal is to further understand the risk factors leading to SCAD with a focus on familial and genetic causes of SCAD.

The "Virtual" Multicenter Spontaneous Coronary Artery Dissection (SCAD) Registry

The primary goal of this project is to describe the clinical and physiologic characteristics of Spontaneous Coronary Artery Dissections (SCAD) in order to increase awareness, understanding, treatment and prevention of a potentially fatal cardiovascular event. This study will be a retrospective and prospective review of medical course and current health of men and women with SCAD.

A Study of SCAD Using Stress Contrast Echocardiography

This study aims to fill knowledge gaps regarding microvascular perfusion and pressor response to stress among patients with history of spontaneous coronary artery dissection (SCAD) using stress contrast echocardiography.

SCAD : a Registry of Spontaneous Coronary Artery Dissection

Spontaneous coronary artery dissection (SCAD) is an increasingly recognised cause of non-atherosclerotic acute coronary syndromes (ACS), predominantly afflicting young women without conventional atherosclerotic risk factors. Knowledge of SCAD has advanced considerably in the last few years as a result of data from a number of local and national registries 1-6. Like all rarer diseases however, a better understanding of SCAD will require international collaboration. At present, there is no European or International SCAD registry despite increasing recognition that there are key differences in the diagnosis, interventional and medical management of SCAD compared with conventional atherosclerotic ACS. The ESC-ACCA Study Group on Spontaneous Coronary Artery Dissection supported by the European Observational Research Programme will now build the first pan-European SCAD registry to advance our understanding of current management of this condition, inform guidelines, educate clinical colleagues and advance research.

Spontaneous Coronary Artery Dissection National Swiss Registry

Spontaneous coronary artery dissection (SCAD), is an underdiagnosed pathology, affecting predominantly young women without traditional cardiovascular risk factors and is associated with major adverse outcomes including myocardial infarction, cardiac arrest, or death. Timely diagnosis of SCAD as well as clinical follow-up are of the essence in this pathology associated with major cardiac adverse outcomes. Despite recent improvements in diagnosis and recognition of the importance of SCAD, it remains poorly studied and understood. In this context, we designed the SwissSCAD registry, a large, observational, prospective, cohort study, to describe the natural history of SCAD, its outcomes and its treatments.

Canadian SCAD Study

Natural history multicenter, prospective, observational registry with 10-year follow-up

Randomized Study of Beta-Blockers and Antiplatelets in Patients With Spontaneous Coronary Artery Dissection

Spontaneous coronary artery dissection (SCAD) is a cause of acute coronary syndrome (ACS). Most patients are treated with beta-blockers (BB) and antiplatelet drugs (AP) on empiric basis. The Beta-Blockers and Antiplatelet Agents in Patients with Spontaneous Coronary Artery Dissection (BA-SCAD) randomized clinical trial is an academic, pragmatic, nation-wide, prospective study developed under the auspices of the Spanish Society of Cardiology (SEC) that aims to assess the efficacy of medical therapy in SCAD patients. Using a factorial 2x2 design, patients will be randomized (1:1/1:1) to: 1) BB (yes/no) and 2) short AP regimen (1 month) vs prolonged dual AP therapy (DAPT) (12 months).Only patients with preserved left ventricular ejection fraction (LVEF) will be randomized to BB (yes/no) because patients with LVEF \<40% will receive BB according to current guidelines. Likewise, only medically managed patients will be randomized to short AP therapy vs 1-year DAPT. The study will have a pragmatic, open label, blind outcomes design (PROBE). A total of 600 SCAD patients will be randomized within 2 years (300 per arm in a factorial 2x2 design). The primary efficacy endpoint will include the composite of death, acute myocardial infarction (MI), stroke, coronary revascularization, recurrent SCAD, and unplanned hospitalization for ACS or heart failure at 1 year. The primary safety endpoint will be bleeding. All patients will be clinically followed yearly. The main study will be pragmatic but a comprehensive set of additional studies (clinical, imaging, biomarkers, inflammatory, immunologic, pharmacogenetic and genetic) will be organized to ensure an holistic view on this challenging condition.