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Spontaneous Coronary Artery DissectionDISCO-IT/SPANCT04415762

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

An observational study of Spontaneous Coronary Artery Dissection, run by San Luigi Gonzaga Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Spontaneous Coronary Artery Dissection
How many people
314 participants
Where
No sites listed yet
Study dates
1 Jan 2009to 31 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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

Read the 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
Keywords
Spontaneous coronary artery dissection, SCAD
Medical subject headings
Coronary Artery Dissection, Spontaneous

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (3)

  1. all-cause of death

    all-cause of death

    Measured: 12 months

  2. non-fatal Myocardial Infarction (MI)

    non-fatal Myocardial Infarction (MI)

    Measured: 12 months

  3. any unplanned revascularization either percutaneous or surgical

    any unplanned revascularization either percutaneous or surgical

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start1 Jan 2009
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04415762
Sponsor's protocol ID
001-2020
Acronym
DISCO-IT/SPA
Status last verified
May 2020
First submitted
20 May 2020
Last updated
4 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37259861

  • 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.

    PubMed 34338759

Questions about this trial

What is this clinical trial studying?

An observational study of Spontaneous Coronary Artery Dissection, run by San Luigi Gonzaga Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04415762, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.

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