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Clinical Trial Details — Status: Recruiting

Administrative data

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

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
Health authority
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
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.

Study Design


Related Conditions & MeSH terms


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
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Completed NCT04415762 - Spontaneous Coronary Artery Dissection Registry (DIssezioni Spontanee COronariche ITalian-SPAnish)
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