Spontaneous Coronary Artery DissectionSCADNCT06601270
SCAD : a Registry of Spontaneous Coronary Artery Dissection
An observational study of Spontaneous Coronary Artery Dissection, run by European Society of Cardiology at 73 sites in 24 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Coronary Artery Dissection
- How many people
- 1,500 participants
- Where
- 73 sitesin 24 countries
- Study dates
- 30 Jan 2021to Oct 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient aged 18 years and over with SCAD clinical diagnosis within the past 10 years and available coronary angiographic imagery.
Who may be able to join
- 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
Who cannot join
- Patient unwilling or unable to consent
- Patients with iatrogenic or atherosclerotic coronary dissection
Trial locations and contacts
73 sites in 24 countries. Contact the study team or a site near you to ask about taking part.
73 sites in 24 countries
Belgium12 sites, 8 recruiting
- Recruiting
AZ Sint jan, current president of Belgian ACCA
Bruges
Patrick Coussement, 32 50 45 26 70, Patrick.coussement@azsintjan.be
- Recruiting
Cliniques Universitaires Saint-Luc (UCL)
Brussels
Alexandre Persu, 00 32 2 764 63 06, alexandre.persu@uclouvain.be
- Active, not recruiting
Universitair Ziekenhuis Brussels
Brussels
- Recruiting
Antwerp University Hospital
Edegem
Steven Haine, +3238214281, Steven.haine@uza.be
- Recruiting
Ziekenhuis Oost Limburg, Interventional cardiology/Coronary Care
Genk
Bert Ferdinande, +32 89 80 4220, bert.ferdinande@zol.be
- Active, not recruiting
AZ Sint Lucas hospital
Ghent
- Recruiting
Ghent University Hospital
Ghent
Sofie Gevaert, +32(0)93324779, sofie.gevaert@ugent.be
- Active, not recruiting
University Hospitals Leuven
Leuven
- Recruiting
CHR La Citadelle
Liège
Suzanne Pourbaix, +32 4 225 69 01, suzanne.pourbaix@chrcitadelle.be
- Active, not recruiting
Les cliniques Saint Pierre
Ottignies
- Recruiting
AZ Delta
Roeselare
Francis Stammen, 003251237277, Francis.stammen@azdelta.be
- Recruiting
AZ Nikolaas
Sint-Niklaas
Joeri 0032484747654, 037602314, Joeri.voet@aznikolaas.be
Italy8 sites, 8 recruiting
- Recruiting
Papa Giovanni XXIII Azienda Ospedaliera
Bergamo
Angelina Vassileva, 00 39 348 252 5436, avassileva@asst-pg23.it
- Recruiting
Policlinico Riuniti Foggia
Foggia
Marco Mele, 3292783415, drmelemarco@yahoo.it
- Recruiting
Ospedale Policlinico San Martino IRCCS, Genova & Università di Genova
Genoa
Italo Porto, 0039 3332545285, italo.porto@unige.it
- Recruiting
Presidio Ospedaliero Carlo Poma
Mantua
Corrado Lettieri, 0376 201303, corrado.lettieri@asst-mantova.it
- Recruiting
ASST Grande Ospedale Niguarda
Milan
Piccaluga Emanuela, 39 3388747398, emanuela.piccaluga@ospedaleniguarda.it
- Recruiting
Centro Cardiologico Monzino, IRCCS
Milan
Daniela Trabattoni, 390258002546, daniela.trabattoni@ccfm.it
- Recruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan
Lucia Barbieri, +393395331077, lb.luciabarbieri@gmail.com
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza
Pietro Vandoni, +39 347 2733809, pietro.vandoni@irccs-sangerardo.it
United Kingdom7 sites, 6 recruiting
- Recruiting
William Harvey Hospital
Ashford
Rampat Rajiv, 01233616271, rajiv.rampat@nhs.net
- Recruiting
Glan Clwyd Hospital
Bodelwyddan
Chetan Upadhyaya, 0044-7841358674, chetan.upadhyaya@wales.nhs.uk
- Recruiting
Bournemouth Hospital
Bournemouth
Peter OKane, 01202 704333, peterdokane@btinternet.com
- Recruiting
Bristol Heart Institute
Bristol
Thomas Johnson, 07961309969, Tom.johnson@uhbristol.nhs.uk
- Recruiting
University Hospitals
Leicester
David Adlam, david.adlam@uhl-tr.nhs.uk
- Active, not recruiting
Royal Brompton & Chelsea & Westminster Hospital
London
- Recruiting
Royal Free Hospital
London
Roby Rakhit, 07950585220, roby.rakhit@nhs.net
France6 sites, 6 recruiting
- Recruiting
CHRU Jean Minjoz
Besançon
François Schiele, +33 3 81 66 86 24, francois.schiele@univ-fcomte.fr
- Recruiting
Gabriel Montpied Hospital - CHU Clermont-Ferrand
Clermont-Ferrand
Motreff Pascal, 33 473 751 421, pmotreff@chu-clermontferrand.fr
- Recruiting
Hôpital de Chartres Louis Pasteur
Le Coudray
Gregoire Range, 06 14 17 36 77, range.gregoire@mac.com
- Recruiting
Cardiovascular Hospital Louis Pradel - Hospices Civils de Lyon
Lyon
Gilles Rioufol, 33 472357092, gilles.rioufol@univ-lyon1.fr
- Recruiting
Hôpital Jacques Cartier
Massy
Hakim Benamer, 01 60 13 46 02, h.benamer@angio-icps.com
- Recruiting
Hôpital Cardiologique du Haut Lévêque - Bordeaux University
Pessac
Edouard Gerbaud, 33 524 549 188, edouard.gerbaud@chu-bordeaux.fr
Austria5 sites, 5 recruiting
- Recruiting
Medical University of Innsbruck, Internal Medicine III
Innsbruck
Wolfgang Dichtl, 004351250481388, dichtl@me.com
- Recruiting
Klinik Landstrasse
Vienna
Ashkan Noorian, 00431711652207, ashkan.noorian@gesundheitsverbund.at
- Recruiting
Klinik Ottakring
Vienna
Alexander Geppert, 01491502308, alexander.geppert@gesundheitsverbund.at
- Recruiting
Medical University of Vienna
Vienna
Jolanta Siller-Matula, 43 1 40400-46140, jolanta.siller-matula@meduniwien.ac.at
- Recruiting
Landesklinikum Wiener Neustadt
Wiener Neustadt
Franz Xaver Roithinger, 43 (0)2622 9004 12702, franzxaver.roithinger@wienerneustadt.lknoe.at
Denmark4 sites, 4 recruiting
- Recruiting
Aarhus University Hospital
Aarhus
Michael Maeng, +45 78 45 00 00, Michael.maeng@ki.au.dk
- Recruiting
Rigshospitalet
Copenhagen
Lene Holmvang, +45 3545 1197, lene.holmvang@regionh.dk
- Recruiting
Herlev and Gentofte Hospital
Hellerup
Mette Gitz Charlot, 45 38677214, Mette.Gitz.Charlot@regionh.dk
- Recruiting
Odense University Hospital
Odense
Lene Huche Nielsen, 004522742135, Lene.Huche.Nielsen@rsyd.dk
Germany4 sites, 4 recruiting
- Recruiting
Schüchtermann-Klinik Bad Rothenfelde
Bad Rothenfelde
Gerold Mönnig, 495424 641 0, gmoennig@schuechtermann-klinik.de
- Recruiting
Vivantes Klinikum in Friedrichshain
Berlin
Darach O h-Ici, 49 30 130 23 1895, darachohici@gmail.com
- Recruiting
University Heart and Vascular Center Hamburg Eppendorf
Hamburg
040 7410 53979, p.clemmensen@uke.de
- Recruiting
Robert Bosch Hospital
Stuttgart
Peter Ong, 49 (0) 711 8101 6048, Peter.Ong@rbk.de
Portugal4 sites, 4 recruiting
- Recruiting
Hospital Fernando Fonseca
Amadora
Sergio Baptista, +351962364061, sergio.b.baptista@gmail.com
- Recruiting
Hospital de Braga
Braga
João Costa, 915303594, jfscosta@gmail.com
- Recruiting
Hospital do Espirito Santo de Evora
Evora
Ana Rita Rocha, +351 916439826, aritacrocha@gmail.com
- Recruiting
Centro Hospitalar Tondela Viseu
Tondela
Luisa Goncalves, (+351) 934120142, malvar.luisa@gmail.com
Brazil3 sites, 3 recruiting
- Recruiting
Hospital Israelita Albert Einstein
São Paulo
Adriano Caixeta, 55 11 95236-2000, acaixeta@me.com
- Recruiting
Instituto do Coração do HCFMUSP
São Paulo
Alexandre Soeiro, +55112661-5299, alexandre.soeiro@bol.com.br
- Recruiting
Universidade Federal de São Paulo (UNIFESP)
São Paulo
Marcos Danilo Oliveira, +55 11 94846 9000, mdmarcosdanillo@gmail.com
Netherlands3 sites, 3 recruiting
- Recruiting
Noordwest Ziekenhuisgroep / NorthWest Clinics
Alkmaar
Maurits Dirksen, 31725482700, m.t.dirksen@nwz.nl
- Recruiting
Amphia Hospital
Breda
Martijn Meuwissen, 31765954105, mmeuwissen@amphia.nl
- Recruiting
Radboud University Medical Centre
Nijmegen
Peter Damman, +31622179330, Peter.damman@radboudumc.nl
Czechia2 sites, 2 recruiting
- Recruiting
Nemocnice Pardubického kraje
Pardubice
Romana Bodnarova, +420 737599334, romankaa.bodnarova@gmail.com
- Recruiting
Hospital Na Homolce
Prague
Petr Volf, 420257272323, petr.volf@homolka.cz
Greece2 sites, 2 recruiting
- Recruiting
Sotiria Thoracic Diseases Hospital
Athens
Michael Spartalis, +306937291476, mspartalis@icloud.com
- Recruiting
General Hospital of Kozani
Kozani
Pavlos Roditis, 0030-6942484954, pavlosrod@hotmail.com
Serbia2 sites, 2 recruiting
- Recruiting
University Hospital Centre Bezanijska Kosa
Belgrade
Aleksandra Djokovic, +381 11 3010777, drsaska@yahoo.com
- Recruiting
Cardiology Clinic, UCC Nis
Niš
Svetlana Apostolovic, +381 631094144, drapostolovic@gmail.com
Argentina1 site, 1 recruiting
- Recruiting
ICBA - Instituto Cardiovascular de Buenos Aires
Buenos Aires
Lucrecia Maria Burgos, 54-91122618921, lburgos@icba.com.ar
Bosnia and Herzegovina1 site, 1 recruiting
- Recruiting
Clinical Center University of Sarajevo
Sarajevo
Alden Begic, +387 61 203 300, aldenbegic@yahoo.com
Croatia1 site, 1 recruiting
- Recruiting
University Hospital of Split (KBC Split)
Split
Josip A. Borovac, +385 92 172 1314, josip.borovac@me.com
Cyprus1 site, 1 recruiting
- Recruiting
Nicosia General Hospital
Nicosia
Christos Eftychiou, 35799692149, chiou6christos@yahoo.com
Iran1 site, 1 recruiting
- Recruiting
Tehran Heart Center
Tehran
Yaser Jenab, 00989123375795, yasjenab@Gmail.com
New Zealand1 site, 1 recruiting
- Recruiting
Auckland City Hospital - Green Lane Cardiovascular Service
Auckland
Mark Webster, 006421520997, mwebster@adhb.govt.nz
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital - Invasive cardiology
Bergen
Nigussie Bogale, +4741309313, nigussie.bogale@lyse.net
Poland1 site, 1 recruiting
- Recruiting
Institute of Cardiology - Department of Interventional Cardiology and Angiology
Warsaw
Jacek Kadziela, 48605298959, jkadziela@onet.pl
Singapore1 site, 1 recruiting
- Recruiting
National University Heart Centre Singapore
Singapore
Kian-Keong Poh, +6592373289, mdcpkk@nus.edu.sg
Slovakia1 site, 1 recruiting
- Recruiting
Stredoslovensky ustav srdcovych a cievnych chorob a.s
Banská Bystrica
Petra Poliacikova, 00421907338689, prepetru@me.com
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de la Princesa
Madrid
Fernando Alfonso, +34 915 20 22 00, falf@hotmail.com
About this study
Official title: A Registry of Spontaneous Coronary Artery Dissection
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.
Read the 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.
- Conditions
- Spontaneous Coronary Artery Dissection
- Being tested
- There are no interventions as the study is purely observational.
- Medical subject headings
- Coronary Artery Dissection, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There are no interventions as the study is purely observational.Other
There are no interventions as the study is purely observational.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | There are no interventions as the study is purely observational. Receives: Other: There are no interventions as the study is purely observational. | |
| Prospective | There are no interventions as the study is purely observational. Receives: Other: There are no interventions as the study is purely observational. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Status:
- Measure: Functional health status and clinical condition during follow-up.
- Unit of Measure: Categorized as stable, improved, or worsened.
Measured: 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 (%).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Up to 5 years post-enrollment
Secondary outcomes (7)
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.
Measured: Up to 5 years post-enrollment
Other Coronary Vascular Events:
- Measure: Occurrence of any other coronary vascular events (e.g., myocardial infarction, ischemia, revascularization).
- Unit of Measure: Number of events.
Measured: Up to 5 years post-enrollment
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).
Measured: Up to 5 years post-enrollment
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).
Measured: Up to 5 years post-enrollment
Exercise History:
-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).
Measured: Up to 5 years post-enrollment
Mental Health and Wellbeing:
-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).
Measured: Up to 5 years post-enrollment
Employment Post-SCAD:
- Measure: Employment status following SCAD event.
- Unit of Measure: Categorical variables (e.g., employed, unemployed, part-time).
Measured: At first follow-up visit only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Jan 2021
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Coronary Artery DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- European Society of Cardiology
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Adham GHARIEB, PharmD, Study director, ESC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601270
- Sponsor's protocol ID
- SCAD registry
- Acronym
- SCAD
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2020
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No