NCT04415762

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
Last Updated

June 4, 2020

Status Verified

May 1, 2020

Enrollment Period

11 years

First QC Date

May 20, 2020

Last Update Submit

May 31, 2020

Conditions

Spontaneous Coronary Artery Dissection

Keywords

Spontaneous coronary artery dissectionSCAD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • all-cause of death

    12 months

  • non-fatal Myocardial Infarction (MI)

    12 months

  • any unplanned revascularization either percutaneous or surgical

    12 months

Other Outcomes (3)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Consecutive patients with a novel diagnosis of Spontaneous Coronary Artery Dissection (SCAD)

You may not qualify if:

  • Age \<18 year old or inability to provide Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Benenati S, Giacobbe F, Zingarelli A, Macaya F, Biole C, Rossi A, Pavani M, Quadri G, Barbero U, Erriquez A, Aranzulla T, Cavallino C, Buccheri D, Rolfo C, Patti G, Gonzalo N, Chinaglia A, Musumeci G, Escaned J, Varbella F, Cerrato E, Porto I; DISCO Collaborators. Interventional Versus Conservative Strategy in Patients With Spontaneous Coronary Artery Dissections: Insights From DISCO Registry. Circ Cardiovasc Interv. 2023 Jun;16(6):e012780. doi: 10.1161/CIRCINTERVENTIONS.122.012780. Epub 2023 Jun 1.

    PMID: 37259861DERIVED

  • 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.

    PMID: 34338759DERIVED

MeSH Terms

Conditions

Coronary Artery Dissection, Spontaneous

Study Officials

  • Enrico Cerrato, MD

    San Luigi Gonzaga University Hospital, Orbassano,Turin, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2020

First Posted

June 4, 2020

Study Start

January 1, 2009

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

June 4, 2020

Record last verified: 2020-05