Clinical trial NCT04415762: Spontaneous Coronary Artery Dissection Registry (DIssezioni Spontanee COronariche ITalian-SPAnish)
Official title: A Multicenter Italian and Spanish Observational Registry on Patients Affected by Spontaneous Coronary Artery Dissection (SCAD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spontaneous Coronary Artery Dissection
Keywords: Spontaneous coronary artery dissection
SCAD
Lead sponsor: San Luigi Gonzaga Hospital
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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

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

Primary outcomes:
measure: Major Cardiovascular Cardiac Events (a composite of all-cause of death, non-fatal Myocardial Infarction (MI) and any unplanned revascularization either percutaneous or surgical)
timeFrame: 12 months
Secondary outcomes:
measure: all-cause of death
timeFrame: 12 months
measure: non-fatal Myocardial Infarction (MI)
timeFrame: 12 months
measure: any unplanned revascularization either percutaneous or surgical
timeFrame: 12 months
Other outcomes:
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
Locations:
Study officials:
affiliation: San Luigi Gonzaga University Hospital, Orbassano,Turin, Italy
name: Enrico Cerrato, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.