SCAD : a Registry of Spontaneous Coronary Artery Dissection (SCAD)

October 28, 2024 updated by: European Society of Cardiology

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Recruiting
        • ICBA - Instituto Cardiovascular de Buenos Aires
        • Contact:
  • Austria
  • Belgium
      • Bruges, Belgium
        • Recruiting
        • AZ Sint jan, current president of Belgian ACCA
        • Contact:
      • Brussels, Belgium
        • Recruiting
        • Cliniques Universitaires Saint-Luc (UCL)
        • Contact:
      • Brussels, Belgium
        • Active, not recruiting
        • Universitair Ziekenhuis Brussels
      • Edegem, Belgium
        • Recruiting
        • Antwerp University Hospital
        • Contact:
      • Genk, Belgium
        • Recruiting
        • Ziekenhuis Oost Limburg, Interventional cardiology/Coronary Care
        • Contact:
      • Gent, Belgium
        • Recruiting
        • Ghent University Hospital
        • Contact:
      • Gent, Belgium
        • Active, not recruiting
        • AZ Sint Lucas hospital
      • Leuven, Belgium
        • Active, not recruiting
        • University Hospitals Leuven
      • Liège, Belgium
      • Ottignies, Belgium
        • Active, not recruiting
        • Les cliniques Saint Pierre
      • Roeselare, Belgium
      • Sint-Niklaas, Belgium
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina
        • Recruiting
        • Clinical Center University of Sarajevo
        • Contact:
  • Brazil
      • Sao Paulo, Brazil
        • Recruiting
        • Hospital Israelita Albert Einstein
        • Contact:
      • Sao Paulo, Brazil
        • Recruiting
        • Instituto do Coração do HCFMUSP
        • Contact:
      • São Paulo, Brazil
        • Recruiting
        • Universidade Federal de São Paulo (UNIFESP)
        • Contact:
  • Croatia
      • Split, Croatia
        • Recruiting
        • University Hospital of Split (KBC Split)
        • Contact:
  • Cyprus
      • Nicosia, Cyprus
        • Recruiting
        • Nicosia General Hospital
        • Contact:
  • Czech Republic
      • Pardubice, Czech Republic
      • Prague, Czech Republic
        • Recruiting
        • Hospital Na Homolce
        • Contact:
  • Denmark
      • Aarhus, Denmark
        • Recruiting
        • Aarhus University Hospital
        • Contact:
      • Copenhagen, Denmark
      • Hellerup, Denmark
      • Odense, Denmark
  • France
      • Besançon, France
      • Clermont-Ferrand, France
      • Le Coudray, France
        • Recruiting
        • Hôpital de Chartres Louis Pasteur
        • Contact:
      • Lyon, France
        • Recruiting
        • Cardiovascular Hospital Louis Pradel - Hospices Civils de Lyon
        • Contact:
      • Massy, France
        • Recruiting
        • Hopital Jacques Cartier
        • Contact:
      • Pessac, France
        • Recruiting
        • Hôpital Cardiologique du Haut Lévêque - Bordeaux University
        • Contact:
  • Germany
      • Bad Rothenfelde, Germany
      • Berlin, Germany
        • Recruiting
        • Vivantes Klinikum in Friedrichshain
        • Contact:
      • Hamburg, Germany
        • Recruiting
        • University Heart and Vascular Center Hamburg Eppendorf
        • Contact:
      • Stuttgart, Germany
        • Recruiting
        • Robert Bosch Hospital
        • Contact:
  • Greece
      • Athens, Greece
        • Recruiting
        • Sotiria Thoracic Diseases Hospital
        • Contact:
      • Kozani, Greece
        • Recruiting
        • General Hospital of Kozani
        • Contact:
  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Recruiting
        • Tehran Heart Center
        • Contact:
  • Italy
      • Bergamo, Italy
        • Recruiting
        • Papa Giovanni XXIII Azienda Ospedaliera
        • Contact:
      • Foggia, Italy
        • Recruiting
        • Policlinico Riuniti Foggia
        • Contact:
      • Genoa, Italy
        • Recruiting
        • Ospedale Policlinico San Martino IRCCS, Genova & Università di Genova
        • Contact:
      • Mantua, Italy
      • Milan, Italy
        • Recruiting
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
        • Contact:
      • Milan, Italy
      • Milan, Italy
        • Recruiting
        • Centro Cardiologico Monzino, IRCCS
        • Contact:
      • Monza, Italy
  • Netherlands
      • Alkmaar, Netherlands
        • Recruiting
        • Noordwest Ziekenhuisgroep / NorthWest Clinics
        • Contact:
      • Breda, Netherlands
        • Recruiting
        • Amphia Hospital
        • Contact:
      • Nijmegen, Netherlands
  • New Zealand
      • Auckland, New Zealand
        • Recruiting
        • Auckland City Hospital - Green Lane Cardiovascular Service
        • Contact:
  • Norway
      • Bergen, Norway
        • Recruiting
        • Haukeland University Hospital - Invasive cardiology
        • Contact:
  • Poland
      • Warsaw, Poland
        • Recruiting
        • Institute of Cardiology - Department of Interventional Cardiology and Angiology
        • Contact:
  • Portugal
      • Amadora, Portugal
      • Braga, Portugal
        • Recruiting
        • Hospital de Braga
        • Contact:
      • Tondela, Portugal
        • Recruiting
        • Centro Hospitalar Tondela Viseu
        • Contact:
      • Évora, Portugal
        • Recruiting
        • Hospital do Espírito Santo de Évora
        • Contact:
  • Serbia
      • Belgrade, Serbia
        • Recruiting
        • University Hospital Centre Bezanijska Kosa
        • Contact:
      • Nis, Serbia
        • Recruiting
        • Cardiology Clinic, UCC Nis
        • Contact:
  • Singapore
      • Singapore, Singapore
        • Recruiting
        • National University Heart Centre Singapore
        • Contact:
  • Slovakia
      • Banska Bystrica, Slovakia
        • Recruiting
        • Stredoslovensky ustav srdcovych a cievnych chorob a.s
        • Contact:
  • Spain
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario De La Princesa
        • Contact:
  • United Kingdom
      • Ashford, United Kingdom
        • Recruiting
        • William Harvey Hospital
        • Contact:
      • Bodelwyddan, United Kingdom
      • Bournemouth, United Kingdom
      • Bristol, United Kingdom
      • Leicester, United Kingdom
      • London, United Kingdom
        • Recruiting
        • Royal Free Hospital
        • Contact:
      • London, United Kingdom
        • Active, not recruiting
        • Royal Brompton & Chelsea & Westminster Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective
There are no interventions as the study is purely observational.
Other: There are no interventions as the study is purely observational.
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.
There are no interventions as the study is purely observational.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Status:
Time Frame: Up to 5 years post-enrollment
  • 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:
Time Frame: Up to 5 years post-enrollment

-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:
Time Frame: Up to 5 years post-enrollment
  • 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:
Time Frame: Up to 5 years post-enrollment
  • 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:
Time Frame: Up to 5 years post-enrollment

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:
Time Frame: Up to 5 years post-enrollment
  • 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:
Time Frame: Up to 5 years post-enrollment
  • 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedures:
Time Frame: Up to 5 years post-enrollment
  • Measure: Documentation of any medical or surgical procedures related to SCAD during follow-up (e.g., coronary interventions).
  • Unit of Measure: Number of procedures.
Up to 5 years post-enrollment
Other Coronary Vascular Events:
Time Frame: Up to 5 years post-enrollment
  • Measure: Occurrence of any other coronary vascular events (e.g., myocardial infarction, ischemia, revascularization).
  • Unit of Measure: Number of events.
Up to 5 years post-enrollment
Symptomatology:
Time Frame: Up to 5 years post-enrollment
  • 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).
Up to 5 years post-enrollment
Pregnancy and Hormonal Therapy (when applicable):
Time Frame: Up to 5 years post-enrollment
  • 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).
Up to 5 years post-enrollment
Exercise History:
Time Frame: Up to 5 years post-enrollment

-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).
Up to 5 years post-enrollment
Mental Health and Wellbeing:
Time Frame: Up to 5 years post-enrollment

-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).
Up to 5 years post-enrollment
Employment Post-SCAD:
Time Frame: At first follow-up visit only
  • Measure: Employment status following SCAD event.
  • Unit of Measure: Categorical variables (e.g., employed, unemployed, part-time).
At first follow-up visit only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Society of Cardiology

Investigators

  • Study Director: Adham GHARIEB, PharmD, ESC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2021

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

September 13, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 28, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCAD registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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