SCAD : a Registry of Spontaneous Coronary Artery Dissection

NCT06601270 | Recruiting

• 1 other identifier: SCAD registry
• Study Type: observational
• Target: 1,500
• Locations: 24 countries
• Sites: 73

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.

Conditions

Spontaneous Coronary Artery Dissection

Outcome Measures

Primary Outcomes (7)

• Patient Status:

  * Measure: Functional health status and clinical condition during follow-up. * Unit of Measure: Categorized as stable, improved, or worsened.

  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 (%).

  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.

  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).

  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.

  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).

  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).

  Up to 5 years post-enrollment

Secondary Outcomes (7)

• Procedures:

  Up to 5 years post-enrollment

• Other Coronary Vascular Events:

  Up to 5 years post-enrollment

• Symptomatology:

  Up to 5 years post-enrollment

• Pregnancy and Hormonal Therapy (when applicable):

  Up to 5 years post-enrollment

• Exercise History:

  Up to 5 years post-enrollment

Study Arms (2)

Retrospective

There are no interventions as the study is purely observational.

Other: There are no interventions as the study is purely observational.

Prospective

There are no interventions as the study is purely observational.

Other: There are no interventions as the study is purely observational.

Interventions

There are no interventions as the study is purely observational. OTHER

There are no interventions as the study is purely observational.

Prospective; Retrospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient aged 18 years and over with SCAD clinical diagnosis within the past 10 years and available coronary angiographic imagery.

You may qualify if:

• 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

You may not qualify if:

• Patient unwilling or unable to consent
• Patients with iatrogenic or atherosclerotic coronary dissection

Sponsors & Collaborators

• European Society of Cardiology: lead

Study Sites (73)

ICBA - Instituto Cardiovascular de Buenos Aires

Buenos Aires, Argentina

RECRUITING

Medical University of Innsbruck, Internal Medicine III

Innsbruck, Austria

RECRUITING

Klinik Landstrasse

Vienna, Austria

RECRUITING

Klinik Ottakring

Vienna, Austria

RECRUITING

Medical University of Vienna

Vienna, Austria

RECRUITING

Landesklinikum Wiener Neustadt

Wiener Neustadt, Austria

RECRUITING

AZ Sint jan, current president of Belgian ACCA

Bruges, Belgium

RECRUITING

Cliniques Universitaires Saint-Luc (UCL)

Brussels, Belgium

RECRUITING

Universitair Ziekenhuis Brussels

Brussels, Belgium

ACTIVE NOT RECRUITING

Antwerp University Hospital

Edegem, Belgium

RECRUITING

Ziekenhuis Oost Limburg, Interventional cardiology/Coronary Care

Genk, Belgium

RECRUITING

AZ Sint Lucas hospital

Ghent, Belgium

ACTIVE NOT RECRUITING

Ghent University Hospital

Ghent, Belgium

RECRUITING

University Hospitals Leuven

Leuven, Belgium

ACTIVE NOT RECRUITING

CHR La Citadelle

Liège, Belgium

RECRUITING

Les cliniques Saint Pierre

Ottignies, Belgium

ACTIVE NOT RECRUITING

AZ Delta

Roeselare, Belgium

RECRUITING

AZ Nikolaas

Sint-Niklaas, Belgium

RECRUITING

Clinical Center University of Sarajevo

Sarajevo, Bosnia and Herzegovina

RECRUITING

Hospital Israelita Albert Einstein

São Paulo, Brazil

RECRUITING

Instituto do Coração do HCFMUSP

São Paulo, Brazil

RECRUITING

Universidade Federal de São Paulo (UNIFESP)

São Paulo, Brazil

RECRUITING

University Hospital of Split (KBC Split)

Split, Croatia

RECRUITING

Nicosia General Hospital

Nicosia, Cyprus

RECRUITING

Nemocnice Pardubického kraje

Pardubice, Czechia

RECRUITING

Hospital Na Homolce

Prague, Czechia

RECRUITING

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Herlev and Gentofte Hospital

Hellerup, Denmark

RECRUITING

Odense University Hospital

Odense, Denmark

RECRUITING

CHRU Jean Minjoz

Besançon, France

RECRUITING

Gabriel Montpied Hospital - CHU Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

Hôpital de Chartres Louis Pasteur

Le Coudray, France

RECRUITING

Cardiovascular Hospital Louis Pradel - Hospices Civils de Lyon

Lyon, France

RECRUITING

Hôpital Jacques Cartier

Massy, France

RECRUITING

Hôpital Cardiologique du Haut Lévêque - Bordeaux University

Pessac, France

RECRUITING

Schüchtermann-Klinik Bad Rothenfelde

Bad Rothenfelde, Germany

RECRUITING

Vivantes Klinikum in Friedrichshain

Berlin, Germany

RECRUITING

University Heart and Vascular Center Hamburg Eppendorf

Hamburg, Germany

RECRUITING

Robert Bosch Hospital

Stuttgart, Germany

RECRUITING

Sotiria Thoracic Diseases Hospital

Athens, Greece

RECRUITING

General Hospital of Kozani

Kozani, Greece

RECRUITING

Tehran Heart Center

Tehran, Iran

RECRUITING

Papa Giovanni XXIII Azienda Ospedaliera

Bergamo, Italy

RECRUITING

Policlinico Riuniti Foggia

Foggia, Italy

RECRUITING

Ospedale Policlinico San Martino IRCCS, Genova & Università di Genova

Genoa, Italy

RECRUITING

Presidio Ospedaliero Carlo Poma

Mantova, Italy

RECRUITING

ASST Grande Ospedale Niguarda

Milan, Italy

RECRUITING

Centro Cardiologico Monzino, IRCCS

Milan, Italy

RECRUITING

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Italy

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy

RECRUITING

Noordwest Ziekenhuisgroep / NorthWest Clinics

Alkmaar, Netherlands

RECRUITING

Amphia Hospital

Breda, Netherlands

RECRUITING

Radboud University Medical Centre

Nijmegen, Netherlands

RECRUITING

Auckland City Hospital - Green Lane Cardiovascular Service

Auckland, New Zealand

RECRUITING

Haukeland University Hospital - Invasive cardiology

Bergen, Norway

RECRUITING

Institute of Cardiology - Department of Interventional Cardiology and Angiology

Warsaw, Poland

RECRUITING

Hospital Fernando Fonseca

Amadora, Portugal

RECRUITING

Hospital de Braga

Braga, Portugal

RECRUITING

Hospital do Espirito Santo de Evora

Evora, Portugal

RECRUITING

Centro Hospitalar Tondela Viseu

Tondela, Portugal

RECRUITING

University Hospital Centre Bezanijska Kosa

Belgrade, Serbia

RECRUITING

Cardiology Clinic, UCC Nis

Niš, Serbia

RECRUITING

National University Heart Centre Singapore

Singapore, Singapore

RECRUITING

Stredoslovensky ustav srdcovych a cievnych chorob a.s

Banská Bystrica, Slovakia

RECRUITING

Hospital Universitario de la Princesa

Madrid, Spain

RECRUITING

William Harvey Hospital

Ashford, United Kingdom

RECRUITING

Glan Clwyd Hospital

Bodelwyddan, United Kingdom

RECRUITING

Bournemouth Hospital

Bournemouth, United Kingdom

RECRUITING

Bristol Heart Institute

Bristol, United Kingdom

RECRUITING

University Hospitals

Leicester, United Kingdom

RECRUITING

Royal Brompton & Chelsea & Westminster Hospital

London, United Kingdom

ACTIVE NOT RECRUITING

Royal Free Hospital

London, United Kingdom

RECRUITING

Related Links

• Sponsor registries

MeSH Terms

Conditions

Coronary Artery Dissection, Spontaneous

Study Officials

• Adham GHARIEB, PharmD

  ESC

  STUDY DIRECTOR

Central Study Contacts

Adham GHARIEB, PharmD

CONTACT

048-388-1770; agharieb@escardio.org

Gabrielle BONNEVILLE

CONTACT

048-987-2082; gbonneville@escardio.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: September 19, 2024
• Study Start: January 30, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3); BO (1); DE (4); AU (5); BR (3); PT (4); CZ (2); DK (4); NZ (1); SG (1); NO (1); SL (1); FR (6); GR (2); ES (1); AR (1); SE (2); IT (8); CR (1); GB (7); CY (1); IR (1); BE (12); PL (1)