Spontaneous Coronary Artery Dissection Registry (DIssezioni Spontanee COronariche ITalian-SPAnish) (DISCO-IT/SPA)

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

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

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 314

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with a novel diagnosis of Spontaneous Coronary Artery Dissection (SCAD) confirmed by core-lab analysis of coronary angiograms and other intravascular imaging available

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause of death	all-cause of death	12 months
non-fatal Myocardial Infarction (MI)	non-fatal Myocardial Infarction (MI)	12 months
any unplanned revascularization either percutaneous or surgical	any unplanned revascularization either percutaneous or surgical	12 months

Other Outcome Measures

Outcome Measure	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: San Luigi Gonzaga Hospital
• Investigators: Principal Investigator: Enrico Cerrato, MD, San Luigi Gonzaga University Hospital, Orbassano,Turin, Italy

Publications and helpful links

General Publications

• Cerrato E, Giacobbe F, Quadri G, Macaya F, Bianco M, Mori R, Biole CA, Boi A, Bettari L, Rolfo C, Ferrari F, Annibali G, Scappaticci M, Pavani M, Barbero U, Buccheri D, Cavallino C, Lombardi P, Bernelli C, D'Ascenzo F, Infantino V, Gambino A, Cinconze S, Rognoni A, Montagna L, Porto I, Musumeci G, Escaned J, Varbella F; DISCO Collaborators. Antiplatelet therapy in patients with conservatively managed spontaneous coronary artery dissection from the multicentre DISCO registry. Eur Heart J. 2021 Aug 31;42(33):3161-3171. doi: 10.1093/eurheartj/ehab372. Erratum In: Eur Heart J. 2021 Dec 28;43(1):87.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 31, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: May 31, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Spontaneous coronary artery dissection; SCAD
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Aneurysm; Vascular Diseases; Aneurysm, Dissecting; Coronary Vessel Anomalies
• Other Study ID Numbers: 001-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No