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Clinical Trials/NCT04415762
NCT04415762
Completed
N/A

A Multicenter Italian and Spanish Observational Registry on Patients Affected by Spontaneous Coronary Artery Dissection (SCAD)

San Luigi Gonzaga Hospital0 sites314 target enrollmentJanuary 1, 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Spontaneous Coronary Artery Dissection
Sponsor
San Luigi Gonzaga Hospital
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)
Status
Completed
Last Updated
5 years ago

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: 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

Registry
clinicaltrials.gov
Start Date
January 1, 2009
End Date
December 31, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
San Luigi Gonzaga Hospital
Responsible Party
Principal Investigator
Principal Investigator

Enrico Cerrato

Principal Investigator

San Luigi Gonzaga Hospital

Eligibility Criteria

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)

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