Clinical trial NCT06601270: SCAD : a Registry of Spontaneous Coronary Artery Dissection
Official title: A Registry of Spontaneous Coronary Artery Dissection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spontaneous Coronary Artery Dissection
Lead sponsor: European Society of Cardiology
Sponsor class: NETWORK
First posted: 2024-09-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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

Primary outcomes:
measure: Patient Status:
timeFrame: Up to 5 years post-enrollment
measure: Vital Signs:
timeFrame: Up to 5 years post-enrollment
measure: Recurrent SCAD Events:
timeFrame: Up to 5 years post-enrollment
measure: Imagery:
timeFrame: Up to 5 years post-enrollment
measure: Medications:
timeFrame: Up to 5 years post-enrollment
measure: Menstrual, Contraceptive, and Obstetric History:
timeFrame: Up to 5 years post-enrollment
measure: Discharge Information:
timeFrame: Up to 5 years post-enrollment
Secondary outcomes:
measure: Procedures:
timeFrame: Up to 5 years post-enrollment
measure: Other Coronary Vascular Events:
timeFrame: Up to 5 years post-enrollment
measure: Symptomatology:
timeFrame: Up to 5 years post-enrollment
measure: Pregnancy and Hormonal Therapy (when applicable):
timeFrame: Up to 5 years post-enrollment
measure: Exercise History:
timeFrame: Up to 5 years post-enrollment
measure: Mental Health and Wellbeing:
timeFrame: Up to 5 years post-enrollment
measure: Employment Post-SCAD:
timeFrame: At first follow-up visit only
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: ICBA - Instituto Cardiovascular de Buenos Aires
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck, Internal Medicine III
city: Vienna
country: Austria
facility: Klinik Landstrasse
city: Vienna
country: Austria
facility: Klinik Ottakring
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Wiener Neustadt
country: Austria
facility: Landesklinikum Wiener Neustadt
city: Bruges
country: Belgium
facility: AZ Sint jan, current president of Belgian ACCA
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc (UCL)
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussels
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg, Interventional cardiology/Coronary Care
city: Gent
country: Belgium
facility: AZ Sint Lucas hospital
city: Gent
country: Belgium
facility: Ghent University Hospital
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Liège
country: Belgium
facility: CHR La Citadelle
city: Ottignies
country: Belgium
facility: Les cliniques Saint Pierre
city: Roeselare
country: Belgium
facility: AZ Delta
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: Sao Paulo
country: Brazil
facility: Instituto do Coração do HCFMUSP
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo (UNIFESP)
city: Split
country: Croatia
facility: University Hospital of Split (KBC Split)
city: Nicosia
country: Cyprus
facility: Nicosia General Hospital
city: Pardubice
country: Czech Republic
facility: Nemocnice Pardubického kraje
city: Prague
country: Czech Republic
facility: Hospital Na Homolce
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Hellerup
country: Denmark
facility: Herlev and Gentofte Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Besançon
country: France
facility: CHRU Jean Minjoz
city: Clermont-Ferrand
country: France
facility: Gabriel Montpied Hospital - CHU Clermont-Ferrand
city: Le Coudray
country: France
facility: Hôpital de Chartres Louis Pasteur
city: Lyon
country: France
facility: Cardiovascular Hospital Louis Pradel - Hospices Civils de Lyon
city: Massy
country: France
facility: Hôpital Jacques Cartier
city: Pessac
country: France
facility: Hôpital Cardiologique du Haut Lévêque - Bordeaux University
city: Bad Rothenfelde
country: Germany
facility: Schüchtermann-Klinik Bad Rothenfelde
city: Berlin
country: Germany
facility: Vivantes Klinikum in Friedrichshain
city: Hamburg
country: Germany
facility: University Heart and Vascular Center Hamburg Eppendorf
city: Stuttgart
country: Germany
facility: Robert Bosch Hospital
city: Athens
country: Greece
facility: Sotiria Thoracic Diseases Hospital
city: Kozani
country: Greece
facility: General Hospital of Kozani
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran Heart Center
city: Bergamo
country: Italy
facility: Papa Giovanni XXIII Azienda Ospedaliera
city: Foggia
country: Italy
facility: Policlinico Riuniti Foggia
city: Genoa
country: Italy
facility: Ospedale Policlinico San Martino IRCCS, Genova &amp; Università di Genova
city: Mantua
country: Italy
facility: Presidio Ospedaliero Carlo Poma
city: Milan
country: Italy
facility: ASST Grande Ospedale Niguarda
city: Milan
country: Italy
facility: Centro Cardiologico Monzino, IRCCS
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep / NorthWest Clinics
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre
city: Auckland
country: New Zealand
facility: Auckland City Hospital - Green Lane Cardiovascular Service
city: Bergen
country: Norway
facility: Haukeland University Hospital - Invasive cardiology
city: Warsaw
country: Poland
facility: Institute of Cardiology - Department of Interventional Cardiology and Angiology
city: Amadora
country: Portugal
facility: Hospital Fernando Fonseca
city: Braga
country: Portugal
facility: Hospital de Braga
city: Tondela
country: Portugal
facility: Centro Hospitalar Tondela Viseu
city: Évora
country: Portugal
facility: Hospital do Espirito Santo de Evora
city: Belgrade
country: Serbia
facility: University Hospital Centre Bezanijska Kosa
city: Nis
country: Serbia
facility: Cardiology Clinic, UCC Nis
city: Singapore
country: Singapore
facility: National University Heart Centre Singapore
city: Banska Bystrica
country: Slovakia
facility: Stredoslovensky ustav srdcovych a cievnych chorob a.s
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Ashford
country: United Kingdom
facility: William Harvey Hospital
city: Bodelwyddan
country: United Kingdom
facility: Glan Clwyd Hospital
city: Bournemouth
country: United Kingdom
facility: Bournemouth Hospital
city: Bristol
country: United Kingdom
facility: Bristol Heart Institute
city: Leicester
country: United Kingdom
facility: University Hospitals
city: London
country: United Kingdom
facility: Royal Brompton &amp; Chelsea &amp; Westminster Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: ESC
name: Adham GHARIEB, PharmD
role: STUDY_DIRECTOR
References: