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

Spontaneous Coronary Artery Dissection Clinical Trial

— DISCO-IT/SPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04415762
• Other study ID #: 001-2020
• Status: Completed
• Start date: January 1, 2009
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2020
• Source: San Luigi Gonzaga Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study will investigate the clinical features, acute management and follow up of patients affected by spontaneous coronary artery dissection

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Spontaneous Coronary Artery Dissection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
San Luigi Gonzaga Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major Cardiovascular Cardiac Events (a composite of all-cause of death, non-fatal Myocardial Infarction (MI) and any unplanned revascularization either percutaneous or surgical) in Single vs Double Antiplatelets therapies in conservatively treated SCAD		12 months
Other	Major Cardiovascular Cardiac Events (a composite of all-cause of death, non-fatal Myocardial Infarction (MI) and any unplanned revascularization either percutaneous or surgical) in Medical treatment vs PCI treated SCAD		12 months
Other	Major Cardiovascular Cardiac Events (a composite of all-cause of death, non-fatal Myocardial Infarction (MI) and any unplanned revascularization either percutaneous or surgical) in different angiographics SCAD type.		12 months
Primary	Major Cardiovascular Cardiac Events (a composite of all-cause of death, non-fatal Myocardial Infarction (MI) and any unplanned revascularization either percutaneous or surgical)	Major Cardiovascular Cardiac Events occurring within 12 months	12 months
Secondary	all-cause of death	all-cause of death	12 months
Secondary	non-fatal Myocardial Infarction (MI)	non-fatal Myocardial Infarction (MI)	12 months
Secondary	any unplanned revascularization either percutaneous or surgical	any unplanned revascularization either percutaneous or surgical	12 months