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

Completed

• Conditions: Spontaneous Coronary Artery Dissection

• Registration Number: NCT04415762
• Lead Sponsor: San Luigi Gonzaga Hospital

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:

1. To assess the characteristics of SCAD patients highlighting the predisposing and precipitating factors related to the acute event

2. To analyze clinical presentation and management of spontaneous coronary dissections in terms of therapeutic approach in the acute phase (conservative therapy vs revascularization)

3. To evaluate the incidence of SCAD recurrence and of major adverse cardiovascular events (MACEs) at follow-up

4. 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

5. To evaluate impact of different angiographic SCAD type on outcome

Study Timeline

• Study Start: 2009-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-05
• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-31
• Last Update Submitted: 2020-05-31
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Cardiovascular Cardiac Events (a composite of all-cause of death, non-fatal Myocardial Infarction (MI) and any unplanned revascularization either percutaneous or surgical)	12 months	Major Cardiovascular Cardiac Events occurring within 12 months

Secondary Outcome Measures

Name	Time	Method
non-fatal Myocardial Infarction (MI)	12 months	non-fatal Myocardial Infarction (MI)
any unplanned revascularization either percutaneous or surgical	12 months	any unplanned revascularization either percutaneous or surgical
all-cause of death	12 months	all-cause of death