A Multicenter Italian and Spanish Observational Registry on Patients Affected by Spontaneous Coronary Artery Dissection (SCAD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 314
- Primary Endpoint
- Major Cardiovascular Cardiac Events (a composite of all-cause of death, non-fatal Myocardial Infarction (MI) and any unplanned revascularization either percutaneous or surgical)
Study Overview
Brief Summary
The study will investigate the clinical features, acute management and follow up of patients affected by spontaneous coronary artery dissection
Detailed Description
Spontaneous Coronary Artery Dissection is now being increasingly studied as it is getting more and more relevant as a cause of ACS. Its management is currently a matter of debate due to the absence of RCT and even the trigger events related to this kind of infarction are still unclear. Notably, the benefits from the use of the antiplatelet medications that prolong bleeding time for a condition whose primary pathophysiology may be an intramural bleed are under discussion.
Hence, the targets pursued by our study may be essentially distinguished in five main points:
- To assess the characteristics of SCAD patients highlighting the predisposing and precipitating factors related to the acute event
- To analyze clinical presentation and management of spontaneous coronary dissections in terms of therapeutic approach in the acute phase (conservative therapy vs revascularization)
- To evaluate the incidence of SCAD recurrence and of major adverse cardiovascular events (MACEs) at follow-up
- To analyze the impact of a single antiplatelet therapy (SAPT) over the dual one (DAPT) along with the impact of different P2Y12i regimens on acute and long-term prognosis
- To evaluate impact of different angiographic SCAD type on outcome
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Consecutive patients with a novel diagnosis of Spontaneous Coronary Artery Dissection (SCAD)
Exclusion Criteria
- •Age <18 year old or inability to provide Informed Consent
Outcomes
Primary Outcomes
Major Cardiovascular Cardiac Events (a composite of all-cause of death, non-fatal Myocardial Infarction (MI) and any unplanned revascularization either percutaneous or surgical)
Time Frame: 12 months
Major Cardiovascular Cardiac Events occurring within 12 months
Secondary Outcomes
- non-fatal Myocardial Infarction (MI)(12 months)
- any unplanned revascularization either percutaneous or surgical(12 months)
- all-cause of death(12 months)
Investigators
Enrico Cerrato
Principal Investigator
San Luigi Gonzaga Hospital