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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04415762
Acronym
DISCO-IT/SPA
Enrollment
314
Registered
2020-06-04
Start date
2009-01-01
Completion date
2019-12-31
Last updated
2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous Coronary Artery Dissection

Keywords

Spontaneous coronary artery dissection, SCAD

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

Interventions

None listed

Sponsors

San Luigi Gonzaga Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
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 monthsMajor Cardiovascular Cardiac Events occurring within 12 months

Secondary

MeasureTime frameDescription
all-cause of death12 monthsall-cause of death
non-fatal Myocardial Infarction (MI)12 monthsnon-fatal Myocardial Infarction (MI)
any unplanned revascularization either percutaneous or surgical12 monthsany unplanned revascularization either percutaneous or surgical

Other

MeasureTime 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 Medical treatment vs PCI treated SCAD12 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
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 SCAD12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026