Spontaneous Coronary Artery Dissection
Conditions
Brief summary
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.
Detailed description
Observational, multicentre, international retrospective and prospective cohort study. Since this is an observational study, a formal sample size is not necessary. At least 500 prospectively recruited patients and 500 historical cases will be enrolled. Patient data will be collected at the following time-points: * First SCAD event visit (retrospectively on chart review) * First follow-up: at time of enrolment * Yearly follow-up: up to 1, 2, 3, 4 and 5 years post enrolment or until study completion Approximately 30 countries and 120 sites will participate in this registry.
Interventions
OTHERThere are no interventions as the study is purely observational.
There are no interventions as the study is purely observational.
Sponsors
European Society of Cardiology
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient having signed an Informed Consent * Patient aged 18 years and over * SCAD clinical diagnosis within the past 10 years and available coronary angiographic imagery
Exclusion criteria
* Patient unwilling or unable to consent * Patients with iatrogenic or atherosclerotic coronary dissection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discharge Information: | Up to 5 years post-enrollment | * Measure: Discharge status following SCAD-related hospital admissions. * Unit of Measure: Categorical variables (e.g., discharged to home, transferred to rehabilitation). |
| Patient Status: | Up to 5 years post-enrollment | * Measure: Functional health status and clinical condition during follow-up. * Unit of Measure: Categorized as stable, improved, or worsened. |
| Vital Signs: | Up to 5 years post-enrollment | -Heart Rate: Measure: Heart rate monitoring. Unit of Measure: Beats per minute (bpm). -Blood Pressure: Measure: Systolic and diastolic blood pressure measurement. Unit of Measure: Millimeters of mercury (mmHg). -Oxygen Saturation: Measure: Oxygen saturation monitoring. Unit of Measure: Percentage (%). |
| Recurrent SCAD Events: | Up to 5 years post-enrollment | * Measure: Documentation of recurrent SCAD events, including clinical presentation, diagnosis, management, and procedures. * Unit of Measure: Number of recurrent SCAD events. |
| Imagery: | Up to 5 years post-enrollment | * Measure: Coronary angiography anonymized and sent for central review (Corelab) for confirmation and analysis. * Unit of Measure: Yes/No (whether imagery was obtained and sent). |
| Medications: | Up to 5 years post-enrollment | Antiplatelet Medications: * Measure: Use of antiplatelet medications during follow-up. Unit of Measure: Number of antiplatelet medications prescribed. * Beta-Blockers: Measure: Use of beta-blocker medications during follow-up. Unit of Measure: Number of beta-blockers prescribed. -ACE Inhibitors/ARBs: Measure: Use of ACE inhibitors or angiotensin receptor blockers (ARBs) during follow-up. Unit of Measure: Number of ACE inhibitors/ARBs prescribed. -Calcium Channel Blockers: Measure: Use of calcium channel blockers during follow-up. Unit of Measure: Number of calcium channel blockers prescribed. -Statins: Measure: Use of statin medications during follow-up. Unit of Measure: Number of statins prescribed. -Other Medications (if applicable): Measure: Use of other medication classes during follow-up. Unit of Measure: Number and type of additional medications prescribed. |
| Menstrual, Contraceptive, and Obstetric History: | Up to 5 years post-enrollment | * Measure: Menstrual status, use of contraceptives, and obstetric history during follow-up. * Unit of Measure: Categorical variables (e.g., premenopausal, postmenopausal; use of contraceptives: Yes/No). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedures: | Up to 5 years post-enrollment | * Measure: Documentation of any medical or surgical procedures related to SCAD during follow-up (e.g., coronary interventions). * Unit of Measure: Number of procedures. |
| Other Coronary Vascular Events: | Up to 5 years post-enrollment | * Measure: Occurrence of any other coronary vascular events (e.g., myocardial infarction, ischemia, revascularization). * Unit of Measure: Number of events. |
| Symptomatology: | Up to 5 years post-enrollment | * Measure: Patient-reported symptoms related to cardiovascular health (e.g., chest pain, dyspnea, palpitations). * Unit of Measure: Symptom frequency and severity (scale-based or categorical, e.g., mild, moderate, severe). |
| Pregnancy and Hormonal Therapy (when applicable): | Up to 5 years post-enrollment | * Measure: Pregnancy status and use of hormonal therapy during follow-up. * Unit of Measure: Categorical variables (e.g., pregnant: Yes/No; hormonal therapy: Yes/No). |
| Exercise History: | Up to 5 years post-enrollment | -Exercise Frequency: Measure: Frequency of exercise sessions per week. Unit of Measure: Times per week. -Exercise Duration: Measure: Duration of each exercise session. Unit of Measure: Minutes per session. -Type of Exercise: Measure: Type of physical activity performed (e.g., aerobic, resistance, flexibility). Unit of Measure: Categorical variables (e.g., aerobic, resistance, flexibility). |
| Mental Health and Wellbeing: | Up to 5 years post-enrollment | -Anxiety (HADS-A): Measure: Anxiety levels assessed using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A). Unit of Measure: HADS-A score (range: 0 to 21; higher scores indicate worse anxiety symptoms). -Depression (PHQ-9): Measure: Depression levels assessed using the Patient Health Questionnaire-9 (PHQ-9). Unit of Measure: PHQ-9 score (range: 0 to 27; higher scores indicate worse depression symptoms). -Overall Wellbeing: Measure: Overall wellbeing rating on a self-reported scale. Unit of Measure: Wellbeing rating score (range: 1 to 10; higher scores indicate better wellbeing). |
| Employment Post-SCAD: | At first follow-up visit only | * Measure: Employment status following SCAD event. * Unit of Measure: Categorical variables (e.g., employed, unemployed, part-time). |
Countries
Argentina, Austria, Belgium, Bosnia and Herzegovina, Brazil, Croatia, Cyprus, Czechia, Denmark, France, Germany, Greece, Iran, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Serbia, Singapore, Slovakia, Spain, United Kingdom
Contacts
Primary ContactAdham GHARIEB, PharmD
Backup ContactGabrielle BONNEVILLE
Outcome results
None listed