SCAD : a Registry of Spontaneous Coronary Artery Dissection

Recruiting

• Conditions: Spontaneous Coronary Artery Dissection

• Registration Number: NCT06601270
• Lead Sponsor: European Society of Cardiology

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.

Study Timeline

• Study First Submitted: 2020-10-15
• Study Start: 2021-01-30
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-29
• Primary Completion: 2026-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).
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).

Secondary Outcome Measures

Name	Time	Method
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).
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).

Trial Locations

Locations (73)

ICBA - Instituto Cardiovascular de Buenos Aires; 🇦🇷 Buenos Aires, Argentina

Medical University of Innsbruck, Internal Medicine III; 🇦🇹 Innsbruck, Austria

Klinik Landstrasse; 🇦🇹 Vienna, Austria

Klinik Ottakring; 🇦🇹 Vienna, Austria

Medical University of Vienna; 🇦🇹 Vienna, Austria

Landesklinikum Wiener Neustadt; 🇦🇹 Wiener Neustadt, Austria

AZ Sint jan, current president of Belgian ACCA; 🇧🇪 Bruges, Belgium

Cliniques Universitaires Saint-Luc (UCL); 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Brussels; 🇧🇪 Brussels, Belgium

Antwerp University Hospital; 🇧🇪 Edegem, Belgium

Ziekenhuis Oost Limburg, Interventional cardiology/Coronary Care; 🇧🇪 Genk, Belgium

AZ Sint Lucas hospital; 🇧🇪 Gent, Belgium

Ghent University Hospital; 🇧🇪 Gent, Belgium

University Hospitals Leuven; 🇧🇪 Leuven, Belgium

CHR La Citadelle; 🇧🇪 Liège, Belgium

Les cliniques Saint Pierre; 🇧🇪 Ottignies, Belgium

AZ Delta; 🇧🇪 Roeselare, Belgium

AZ Nikolaas; 🇧🇪 Sint-Niklaas, Belgium

Clinical Center University of Sarajevo; 🇧🇦 Sarajevo, Bosnia and Herzegovina

Hospital Israelita Albert Einstein; 🇧🇷 Sao Paulo, Brazil

Instituto do Coração do HCFMUSP; 🇧🇷 Sao Paulo, Brazil

Universidade Federal de São Paulo (UNIFESP); 🇧🇷 São Paulo, Brazil

University Hospital of Split (KBC Split); 🇭🇷 Split, Croatia

Nicosia General Hospital; 🇨🇾 Nicosia, Cyprus

Nemocnice Pardubického kraje; 🇨🇿 Pardubice, Czech Republic

Hospital Na Homolce; 🇨🇿 Prague, Czech Republic

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Herlev and Gentofte Hospital; 🇩🇰 Hellerup, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

CHRU Jean Minjoz; 🇫🇷 Besançon, France

Gabriel Montpied Hospital - CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Hôpital de Chartres Louis Pasteur; 🇫🇷 Le Coudray, France

Cardiovascular Hospital Louis Pradel - Hospices Civils de Lyon; 🇫🇷 Lyon, France

Hôpital Jacques Cartier; 🇫🇷 Massy, France

Hôpital Cardiologique du Haut Lévêque - Bordeaux University; 🇫🇷 Pessac, France

Schüchtermann-Klinik Bad Rothenfelde; 🇩🇪 Bad Rothenfelde, Germany

Vivantes Klinikum in Friedrichshain; 🇩🇪 Berlin, Germany

University Heart and Vascular Center Hamburg Eppendorf; 🇩🇪 Hamburg, Germany

Robert Bosch Hospital; 🇩🇪 Stuttgart, Germany

Sotiria Thoracic Diseases Hospital; 🇬🇷 Athens, Greece

General Hospital of Kozani; 🇬🇷 Kozani, Greece

Tehran Heart Center; 🇮🇷 Tehran, Iran, Islamic Republic of

Papa Giovanni XXIII Azienda Ospedaliera; 🇮🇹 Bergamo, Italy

Policlinico Riuniti Foggia; 🇮🇹 Foggia, Italy

Ospedale Policlinico San Martino IRCCS, Genova & Università di Genova; 🇮🇹 Genoa, Italy

Presidio Ospedaliero Carlo Poma; 🇮🇹 Mantua, Italy

ASST Grande Ospedale Niguarda; 🇮🇹 Milan, Italy

Centro Cardiologico Monzino, IRCCS; 🇮🇹 Milan, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy

Fondazione IRCCS San Gerardo dei Tintori; 🇮🇹 Monza, Italy

Noordwest Ziekenhuisgroep / NorthWest Clinics; 🇳🇱 Alkmaar, Netherlands

Amphia Hospital; 🇳🇱 Breda, Netherlands

Radboud University Medical Centre; 🇳🇱 Nijmegen, Netherlands

Auckland City Hospital - Green Lane Cardiovascular Service; 🇳🇿 Auckland, New Zealand

Haukeland University Hospital - Invasive cardiology; 🇳🇴 Bergen, Norway

Institute of Cardiology - Department of Interventional Cardiology and Angiology; 🇵🇱 Warsaw, Poland

Hospital Fernando Fonseca; 🇵🇹 Amadora, Portugal

Hospital de Braga; 🇵🇹 Braga, Portugal

Centro Hospitalar Tondela Viseu; 🇵🇹 Tondela, Portugal

Hospital do Espirito Santo de Evora; 🇵🇹 Évora, Portugal

University Hospital Centre Bezanijska Kosa; 🇷🇸 Belgrade, Serbia

Cardiology Clinic, UCC Nis; 🇷🇸 Nis, Serbia

National University Heart Centre Singapore; 🇸🇬 Singapore, Singapore

Stredoslovensky ustav srdcovych a cievnych chorob a.s; 🇸🇰 Banska Bystrica, Slovakia

Hospital Universitario de la Princesa; 🇪🇸 Madrid, Spain

William Harvey Hospital; 🇬🇧 Ashford, United Kingdom

Glan Clwyd Hospital; 🇬🇧 Bodelwyddan, United Kingdom

Bournemouth Hospital; 🇬🇧 Bournemouth, United Kingdom

Bristol Heart Institute; 🇬🇧 Bristol, United Kingdom

University Hospitals; 🇬🇧 Leicester, United Kingdom

Royal Brompton & Chelsea & Westminster Hospital; 🇬🇧 London, United Kingdom

Royal Free Hospital; 🇬🇧 London, United Kingdom