Spontaneous Coronary Artery Dissection Clinical Trial
— SwissSCADOfficial title:
Spontaneous Coronary Artery Dissection (SCAD) National Swiss Registry (SwissSCAD)
NCT number | NCT04457544 |
Other study ID # | 2019-01886 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 12, 2020 |
Est. completion date | June 30, 2030 |
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | June 30, 2030 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | |
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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Geneva University Hospitals | Geneva |
Lead Sponsor | Collaborator |
---|---|
Dr. Sophie Degrauwe |
Switzerland,
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 |
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