Spontaneous Coronary Artery Dissection National Swiss Registry

NCT04457544 | Recruiting

• 1 other identifier: 2019-01886
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spontaneous Coronary Artery Dissection

Outcome Measures

Primary Outcomes (1)

• Incidence of safety events at 30 days

  Incidence of Major cardiovascular outcomes (MACE) at 30 days

  30 days

Secondary Outcomes (2)

• Incidence of safety events at 1 year

  1 year

• Incidence of safety events at 5 years

  5 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Sophie Degrauwe: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Dissection, Spontaneous

Study Officials

• Sophie Degrauwe, Dr

  Hopitaux universitaires de Geneve

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Degrauwe, Dr

CONTACT

+41795530294; sophie.degrauwe@hcuge.ch

Veronique Menoni, PhD

CONTACT

+41795530917; Veronique.Menoni@hcuge.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: July 7, 2020
• Study Start: August 12, 2020
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2030
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

CH (1)