SCAD : a Registry of Spontaneous Coronary Artery Dissection

Official title

A Registry of Spontaneous Coronary Artery Dissection

Overview

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

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

Primary outcome measures

• Patient Status: [Time frame: Up to 5 years post-enrollment]
• Vital Signs: [Time frame: Up to 5 years post-enrollment]
• Recurrent SCAD Events: [Time frame: Up to 5 years post-enrollment]
• Imagery: [Time frame: Up to 5 years post-enrollment]
• Medications: [Time frame: Up to 5 years post-enrollment]
• Menstrual, Contraceptive, and Obstetric History: [Time frame: Up to 5 years post-enrollment]
• Discharge Information: [Time frame: Up to 5 years post-enrollment]

Secondary outcome measures (7)

• Procedures: [Time frame: Up to 5 years post-enrollment]
• Other Coronary Vascular Events: [Time frame: Up to 5 years post-enrollment]
• Symptomatology: [Time frame: Up to 5 years post-enrollment]
• Pregnancy and Hormonal Therapy (when applicable): [Time frame: Up to 5 years post-enrollment]
• Exercise History: [Time frame: Up to 5 years post-enrollment]
• Mental Health and Wellbeing: [Time frame: Up to 5 years post-enrollment]
• Employment Post-SCAD: [Time frame: At first follow-up visit only]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Belgium · 12 centers

• AZ Sint jan, current president of Belgian ACCA — Bruges
• Cliniques Universitaires Saint-Luc (UCL) — Brussels
• Universitair Ziekenhuis Brussels — Brussels
• Antwerp University Hospital — Edegem
• Ziekenhuis Oost Limburg, Interventional cardiology/Coronary Care — Genk
• AZ Sint Lucas hospital — Ghent
• Ghent University Hospital — Ghent
• University Hospitals Leuven — Leuven
• … and 4 more centers

Italy · 8 centers

• Papa Giovanni XXIII Azienda Ospedaliera — Bergamo
• Policlinico Riuniti Foggia — Foggia
• Ospedale Policlinico San Martino IRCCS, Genova & Università di Genova — Genoa
• Presidio Ospedaliero Carlo Poma — Mantua
• ASST Grande Ospedale Niguarda — Milan
• Centro Cardiologico Monzino, IRCCS — Milan
• Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico — Milan
• Fondazione IRCCS San Gerardo dei Tintori — Monza

United Kingdom · 7 centers

• William Harvey Hospital — Ashford
• Glan Clwyd Hospital — Bodelwyddan
• Bournemouth Hospital — Bournemouth
• Bristol Heart Institute — Bristol
• University Hospitals — Leicester
• Royal Brompton & Chelsea & Westminster Hospital — London
• Royal Free Hospital — London

France · 6 centers

• CHRU Jean Minjoz — Besançon
• Gabriel Montpied Hospital - CHU Clermont-Ferrand — Clermont-Ferrand
• Hôpital de Chartres Louis Pasteur — Le Coudray
• Cardiovascular Hospital Louis Pradel - Hospices Civils de Lyon — Lyon
• Hôpital Jacques Cartier — Massy
• Hôpital Cardiologique du Haut Lévêque - Bordeaux University — Pessac

Austria · 5 centers

• Medical University of Innsbruck, Internal Medicine III — Innsbruck
• Klinik Landstrasse — Vienna
• Klinik Ottakring — Vienna
• Medical University of Vienna — Vienna
• Landesklinikum Wiener Neustadt — Wiener Neustadt

Denmark · 4 centers

• Aarhus University Hospital — Aarhus
• Rigshospitalet — Copenhagen
• Herlev and Gentofte Hospital — Hellerup
• Odense University Hospital — Odense

Germany · 4 centers

• Schüchtermann-Klinik Bad Rothenfelde — Bad Rothenfelde
• Vivantes Klinikum in Friedrichshain — Berlin
• University Heart and Vascular Center Hamburg Eppendorf — Hamburg
• Robert Bosch Hospital — Stuttgart

Portugal · 4 centers

• Hospital Fernando Fonseca — Amadora
• Hospital de Braga — Braga
• Hospital do Espirito Santo de Evora — Evora
• Centro Hospitalar Tondela Viseu — Tondela

Brazil · 3 centers

• Hospital Israelita Albert Einstein — São Paulo
• Instituto do Coração do HCFMUSP — São Paulo
• Universidade Federal de São Paulo (UNIFESP) — São Paulo

Netherlands · 3 centers

• Noordwest Ziekenhuisgroep / NorthWest Clinics — Alkmaar
• Amphia Hospital — Breda
• Radboud University Medical Centre — Nijmegen

Czechia · 2 centers

• Nemocnice Pardubického kraje — Pardubice
• Hospital Na Homolce — Prague

Greece · 2 centers

• Sotiria Thoracic Diseases Hospital — Athens
• General Hospital of Kozani — Kozani

Serbia · 2 centers

• University Hospital Centre Bezanijska Kosa — Belgrade
• Cardiology Clinic, UCC Nis — Niš

Argentina · 1 center

• ICBA - Instituto Cardiovascular de Buenos Aires — Buenos Aires

Bosnia and Herzegovina · 1 center

• Clinical Center University of Sarajevo — Sarajevo

Croatia · 1 center

• University Hospital of Split (KBC Split) — Split

Cyprus · 1 center

• Nicosia General Hospital — Nicosia

Iran · 1 center

• Tehran Heart Center — Tehran

New Zealand · 1 center

• Auckland City Hospital - Green Lane Cardiovascular Service — Auckland

Norway · 1 center

• Haukeland University Hospital - Invasive cardiology — Bergen

Poland · 1 center

• Institute of Cardiology - Department of Interventional Cardiology and Angiology — Warsaw

Singapore · 1 center

• National University Heart Centre Singapore — Singapore

Slovakia · 1 center

• Stredoslovensky ustav srdcovych a cievnych chorob a.s — Banská Bystrica

Spain · 1 center

• Hospital Universitario de la Princesa — Madrid

Identifiers

NCT: NCT06601270 · SCAD registry

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗