Spontaneous Coronary Artery Dissection National Swiss Registry

Spontaneous Coronary Artery Dissection Clinical Trial

— SwissSCAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04457544
• Other study ID #: 2019-01886
• Status: Recruiting
• Start date: August 12, 2020
• Est. completion date: June 30, 2030

Study information

• Verified date: November 2022
• Source: University Hospital, Geneva
• Contact: Sophie Degrauwe, Dr
• Phone: +41795530294
• Email: sophie.degrauwe[@]hcuge.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2030
• Est. primary completion date: June 30, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Coronary Vessel Anomalies
• Spontaneous Coronary Artery Dissection
• Vascular Diseases

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Sophie Degrauwe

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of safety events at 30 days	Incidence of Major cardiovascular outcomes (MACE) at 30 days	30 days
Secondary	Incidence of safety events at 1 year	Incidence of Major cardiovascular outcomes (MACE) at 1 year	1 year
Secondary	Incidence of safety events at 5 years	Incidence of Major cardiovascular outcomes (MACE) at 5 years	5 years