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Completed

NCT Number: NCT04415762

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

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

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Key information

Conditions

Spontaneous Coronary Artery Dissection Coronary Artery Dissection, Spontaneous

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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:

  • To assess the characteristics of SCAD patients highlighting the predisposing and precipitating factors related to the acute event
  • To analyze clinical presentation and management of spontaneous coronary dissections in terms of therapeutic approach in the acute phase (conservative therapy vs revascularization)
  • To evaluate the incidence of SCAD recurrence and of major adverse cardiovascular events (MACEs) at follow-up
  • 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
  • To evaluate impact of different angiographic SCAD type on outcome

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

    Time frame: 12 months

    Major Cardiovascular Cardiac Events occurring within 12 months

Secondary outcomes

  1. all-cause of death

    Time frame: 12 months

    all-cause of death

  2. non-fatal Myocardial Infarction (MI)

    Time frame: 12 months

    non-fatal Myocardial Infarction (MI)

  3. any unplanned revascularization either percutaneous or surgical

    Time frame: 12 months

    any unplanned revascularization either percutaneous or surgical

Other 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) in Single vs Double Antiplatelets therapies in conservatively treated SCAD

    Time frame: 12 months

  2. 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

    Time frame: 12 months

  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 different angiographics SCAD type.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

San Luigi Gonzaga Hospital

Other

Registry information

Official study title

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

Acronym: DISCO-IT/SPA

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
Jun 4, 2020
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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