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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,500
There are no interventions as the study is purely observational.
ICBA - Instituto Cardiovascular de Buenos Aires
Buenos Aires, Argentina
RECRUITINGMedical University of Innsbruck, Internal Medicine III
Innsbruck, Austria
RECRUITINGKlinik Landstrasse
Vienna, Austria
RECRUITINGKlinik Ottakring
Vienna, Austria
Patient Status:
* Measure: Functional health status and clinical condition during follow-up. * Unit of Measure: Categorized as stable, improved, or worsened.
Time frame: Up to 5 years post-enrollment
Vital Signs:
-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 (%).
Time frame: Up to 5 years post-enrollment
Recurrent SCAD Events:
* Measure: Documentation of recurrent SCAD events, including clinical presentation, diagnosis, management, and procedures. * Unit of Measure: Number of recurrent SCAD events.
Time frame: Up to 5 years post-enrollment
Imagery:
* 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).
Time frame: Up to 5 years post-enrollment
Medications:
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.
Time frame: Up to 5 years post-enrollment
Menstrual, Contraceptive, and Obstetric History:
* 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).
Time frame: Up to 5 years post-enrollment
Discharge Information:
* Measure: Discharge status following SCAD-related hospital admissions. * Unit of Measure: Categorical variables (e.g., discharged to home, transferred to rehabilitation).
Time frame: Up to 5 years post-enrollment
Procedures:
* Measure: Documentation of any medical or surgical procedures related to SCAD during follow-up (e.g., coronary interventions). * Unit of Measure: Number of procedures.
Time frame: Up to 5 years post-enrollment
Other Coronary Vascular Events:
* Measure: Occurrence of any other coronary vascular events (e.g., myocardial infarction, ischemia, revascularization). * Unit of Measure: Number of events.
Time frame: Up to 5 years post-enrollment
Symptomatology:
* 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).
Time frame: Up to 5 years post-enrollment
Pregnancy and Hormonal Therapy (when applicable):
* 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).
Time frame: Up to 5 years post-enrollment
Exercise History:
-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).
Time frame: Up to 5 years post-enrollment
Mental Health and Wellbeing:
-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).
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Medical University of Vienna
Vienna, Austria
RECRUITINGLandesklinikum Wiener Neustadt
Wiener Neustadt, Austria
RECRUITINGAZ Sint jan, current president of Belgian ACCA
Bruges, Belgium
RECRUITINGCliniques Universitaires Saint-Luc (UCL)
Brussels, Belgium
RECRUITINGUniversitair Ziekenhuis Brussels
Brussels, Belgium
ACTIVE_NOT_RECRUITINGAntwerp University Hospital
Edegem, Belgium
RECRUITING...and 63 more locations
Time frame: Up to 5 years post-enrollment
Employment Post-SCAD:
* Measure: Employment status following SCAD event. * Unit of Measure: Categorical variables (e.g., employed, unemployed, part-time).
Time frame: At first follow-up visit only