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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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.

Adham GHARIEB, PharmD contact

048-388-1770

agharieb@escardio.org

Gabrielle BONNEVILLE contact

048-987-2082

gbonneville@escardio.org

73 sites in 24 countries

Belgium12 sites, 8 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

    Recruiting

  • Universitair Ziekenhuis Brussels

    Brussels

    Active, not 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

    Recruiting

  • AZ Sint Lucas hospital

    Ghent

    Active, not recruiting

  • Ghent University Hospital

    Ghent

    Sofie Gevaert, +32(0)93324779, sofie.gevaert@ugent.be

    Recruiting

  • University Hospitals Leuven

    Leuven

    Active, not recruiting

  • CHR La Citadelle

    Liège

    Suzanne Pourbaix, +32 4 225 69 01, suzanne.pourbaix@chrcitadelle.be

    Recruiting

  • Les cliniques Saint Pierre

    Ottignies

    Active, not recruiting

  • AZ Delta

    Roeselare

    Francis Stammen, 003251237277, Francis.stammen@azdelta.be

    Recruiting

  • AZ Nikolaas

    Sint-Niklaas

    Joeri 0032484747654, 037602314, Joeri.voet@aznikolaas.be

    Recruiting

Other trials in Belgium

Italy8 sites, 8 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

    Recruiting

Other trials in Italy

United Kingdom7 sites, 6 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

    Recruiting

  • Royal Brompton & Chelsea & Westminster Hospital

    London

    Active, not recruiting

  • Royal Free Hospital

    London

    Roby Rakhit, 07950585220, roby.rakhit@nhs.net

    Recruiting

Other trials in United Kingdom

France6 sites, 6 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

    Recruiting

Other trials in France

Austria5 sites, 5 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

    Recruiting

Other trials in Austria

Denmark4 sites, 4 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

    Recruiting

Other trials in Denmark

Germany4 sites, 4 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

    Recruiting

Other trials in Germany

Portugal4 sites, 4 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

    Recruiting

Other trials in Portugal

Brazil3 sites, 3 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

    Recruiting

Other trials in Brazil

Netherlands3 sites, 3 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

    Recruiting

Other trials in Netherlands

Czechia2 sites, 2 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

    Recruiting

Other trials in Czechia

Greece2 sites, 2 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

    Recruiting

Other trials in Greece

Serbia2 sites, 2 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

    Recruiting

Other trials in Serbia

Argentina1 site, 1 recruiting

  • ICBA - Instituto Cardiovascular de Buenos Aires

    Buenos Aires

    Lucrecia Maria Burgos, 54-91122618921, lburgos@icba.com.ar

    Recruiting

Other trials in Argentina

Bosnia and Herzegovina1 site, 1 recruiting

  • Clinical Center University of Sarajevo

    Sarajevo

    Alden Begic, +387 61 203 300, aldenbegic@yahoo.com

    Recruiting

Other trials in Bosnia and Herzegovina

Croatia1 site, 1 recruiting

  • University Hospital of Split (KBC Split)

    Split

    Josip A. Borovac, +385 92 172 1314, josip.borovac@me.com

    Recruiting

Other trials in Croatia

Cyprus1 site, 1 recruiting

  • Nicosia General Hospital

    Nicosia

    Christos Eftychiou, 35799692149, chiou6christos@yahoo.com

    Recruiting

Other trials in Cyprus

Iran1 site, 1 recruiting

  • Tehran Heart Center

    Tehran

    Yaser Jenab, 00989123375795, yasjenab@Gmail.com

    Recruiting

Other trials in Iran

New Zealand1 site, 1 recruiting

  • Auckland City Hospital - Green Lane Cardiovascular Service

    Auckland

    Mark Webster, 006421520997, mwebster@adhb.govt.nz

    Recruiting

Other trials in New Zealand

Norway1 site, 1 recruiting

  • Haukeland University Hospital - Invasive cardiology

    Bergen

    Nigussie Bogale, +4741309313, nigussie.bogale@lyse.net

    Recruiting

Other trials in Norway

Poland1 site, 1 recruiting

  • Institute of Cardiology - Department of Interventional Cardiology and Angiology

    Warsaw

    Jacek Kadziela, 48605298959, jkadziela@onet.pl

    Recruiting

Other trials in Poland

Singapore1 site, 1 recruiting

  • National University Heart Centre Singapore

    Singapore

    Kian-Keong Poh, +6592373289, mdcpkk@nus.edu.sg

    Recruiting

Other trials in Singapore

Slovakia1 site, 1 recruiting

  • Stredoslovensky ustav srdcovych a cievnych chorob a.s

    Banská Bystrica

    Petra Poliacikova, 00421907338689, prepetru@me.com

    Recruiting

Other trials in Slovakia

Spain1 site, 1 recruiting

  • Hospital Universitario de la Princesa

    Madrid

    Fernando Alfonso, +34 915 20 22 00, falf@hotmail.com

    Recruiting

Other trials in Spain

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.

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 groups in NCT06601270
Study groupRoleWhat they receive
RetrospectiveThere are no interventions as the study is purely observational.
Receives: Other: There are no interventions as the study is purely observational.
ProspectiveThere 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  1. First posted19 Sep 2024
  2. Study start30 Jan 2021
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

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
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

Questions about this trial

What is this clinical trial studying?

An observational study of Spontaneous Coronary Artery Dissection, run by European Society of Cardiology at 73 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in Belgium, Italy, United Kingdom, France, Austria and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Adham GHARIEB, PharmD (048-388-1770, agharieb@escardio.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Status: (time frame: Up to 5 years post-enrollment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06601270.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.

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