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

Overview

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

Full Title of Study: “A Multicenter Italian and Spanish Observational Registry on Patients Affected by Spontaneous Coronary Artery Dissection (SCAD)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 31, 2019

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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • San Luigi Gonzaga Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Enrico Cerrato, Principal Investigator – San Luigi Gonzaga Hospital
  • Overall Official(s)
    • Enrico Cerrato, MD, Principal Investigator, San Luigi Gonzaga University Hospital, Orbassano,Turin, Italy

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