Spontaneous Coronary Artery Dissection Registry (DIssezioni Spontanee COronariche ITalian-SPAnish) (DISCO-IT/SPA)

May 31, 2020 updated by: Enrico Cerrato, San Luigi Gonzaga Hospital

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
314

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
all-cause of death
Time Frame: 12 months
all-cause of death
12 months
non-fatal Myocardial Infarction (MI)
Time Frame: 12 months
non-fatal Myocardial Infarction (MI)
12 months
any unplanned revascularization either percutaneous or surgical
Time Frame: 12 months
any unplanned revascularization either percutaneous or surgical
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
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
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
Time Frame: 12 months
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.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
San Luigi Gonzaga Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Enrico Cerrato, MD, San Luigi Gonzaga University Hospital, Orbassano,Turin, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 001-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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