Spontaneous Coronary Artery Dissection National Swiss Registry (SwissSCAD)

Spontaneous Coronary Artery Dissection (SCAD) National Swiss Registry (SwissSCAD)

Spontaneous coronary artery dissection (SCAD), is an underdiagnosed pathology, affecting predominantly young women without traditional cardiovascular risk factors and is associated with major adverse outcomes including myocardial infarction, cardiac arrest, or death.

Timely diagnosis of SCAD as well as clinical follow-up are of the essence in this pathology associated with major cardiac adverse outcomes. Despite recent improvements in diagnosis and recognition of the importance of SCAD, it remains poorly studied and understood.

In this context, we designed the SwissSCAD registry, a large, observational, prospective, cohort study, to describe the natural history of SCAD, its outcomes and its treatments.

Study Overview

• Status: Recruiting
• Conditions: Spontaneous Coronary Artery Dissection

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Sophie Degrauwe, Dr; Phone Number: +41795530294; Email: sophie.degrauwe@hcuge.ch
• Study Contact Backup: Name: Veronique Menoni, PhD; Phone Number: +41795530917; Email: Veronique.Menoni@hcuge.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Recruiting
    • Geneva University Hospitals
    • Contact: Sophie Degrauwe, MD; Email: sophie.degrauwe@hcuge.ch
    • Contact: Véronique Menoni; Email: veronique.menoni@hcuge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This observational study will recruit consecutive male and female patients presenting with newly diagnosed SCAD or having been diagnosed with SCAD within the last 5 years.

For the purposes of study inclusion, the definition of SCAD will be based on a central review of the coronary angiographic images confirmed by 2 independent assessors

Description

Inclusion Criteria:

• Subject is ≥18 years of age.
• Patient presenting newly diagnosed SCAD or diagnosed with SCAD within the last 5 years.
• Subject must be willing to sign a Patient Informed Consent (PIC).

Exclusion Criteria:

• Patient unwilling or unable to provide informed consent.
• Patients with atherosclerotic or iatrogenic coronary dissection.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Retrospective patients; The investigators will review the hospital records at the investigational site for SCAD events having occurred over the last 5 years. All SCAD patients aged ≥18 years, not presenting atherosclerotic or iatrogenic coronary dissection will be informed about the SwissSCAD study by phone and will be given at least one week to decide if they wish to participate. We plan to include 500 patients in the retrospective arm.
Prospective patients; Patients presenting at the hospital with newly diagnosed SCAD will be informed of the SwissSCAD study and will be given at least one week to decide if they wish to participate. We plan to include 500 patients in the prospective arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of safety events at 30 days	Incidence of Major cardiovascular outcomes (MACE) at 30 days	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of safety events at 1 year	Incidence of Major cardiovascular outcomes (MACE) at 1 year	1 year
Incidence of safety events at 5 years	Incidence of Major cardiovascular outcomes (MACE) at 5 years	5 years

Collaborators and Investigators

• Sponsor: Dr. Sophie Degrauwe
• Investigators: Principal Investigator: Sophie Degrauwe, Dr, Hopitaux universitaires de Geneve

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 12, 2020
• Primary Completion (ANTICIPATED): June 30, 2025
• Study Completion (ANTICIPATED): June 30, 2030

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (ACTUAL): July 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 13, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Aneurysm; Vascular Diseases; Aneurysm, Dissecting; Coronary Vessel Anomalies
• Other Study ID Numbers: 2019-01886

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No