SCAD : a Registry of Spontaneous Coronary Artery Dissection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Society of Cardiology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient unwilling or unable to consent
Patients with iatrogenic or atherosclerotic coronary dissection
Trial population
Patient aged 18 years and over with SCAD clinical diagnosis within the past 10 years and available coronary angiographic imagery.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
There are no interventions as the study is purely observational.
Other interventionThere are no interventions as the study is purely observational.
Treatment groups
1,500 Participants
are divided into 2 treatment groupsGroup A: Retrospective1 intervention
Group B: Prospective1 intervention
Trial outcomes
Primary outcomes
1
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-enrollment2
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-enrollment3
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-enrollment4
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-enrollmentSecondary outcomes
1
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-enrollment2
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-enrollment3
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-enrollment4
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-enrollmentSponsors and contacts
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Source ClinicalTrials.gov