Modalities And Safety Of Cardiac Rehabilitation In A Population Managed For Spontaneous Hematoma Or Coronary Disruption (READAPT-DISCO)

February 28, 2023 updated by: University Hospital, Bordeaux

Modalities And Safety Of Cardiac Rehabilitation In A Population Managed For Spontaneous Hematoma Or Coronary Disruption (DISCO): Data From The DISCO Study

Spontaneous Coronary Artery Dissection (SCAD) is a rare and often misdiagnosed cause of Acute Coronary Syndrome (ACS) affecting predominantly young women without cardiovascular risk factors. There is no definitive evidence on the optimal management of SCAD, but the general approach is conservative.

Unlike established evidence-based rehabilitation programs for ACS and heart failure, no cardiac rehabilitation protocol exists for SCAD.

The aim of the study is to report and detail the cardiac rehabilitation program which was proposed to patients previously included in The Study of the Prevalence Fibromuscular Dysplasia in Patient With Haematoma or Spontaneous Coronary Artery Dissection. (DISCO trial - NCT02799186).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The cardiac rehabilitation program was proposed to the patients presenting with SCAD in each interventional cardiology department, according physician's in charge of the patient decision.

The patient who has undergone a cardiac rehabilitation program following the ACS is included in a retrospective way. The patients are informed about this study by the investigator. After a reflection period, the patient is included.

Details regarding the entrance psychosocial evaluation, the entrance exercise treadmill test, the medications changes during rehabilitation, the training program modalities, the exit exercise treadmill test, and the left ventricular ejection fraction evolution (evaluated by echocardiography) were recorded. The safety for each cardiac rehabilitation program was also assessed.

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

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

Patient previsouly recruited in the DISCO Registry with cardiac rehabilitation following the management of acute coronary syndrome

Description

Inclusion Criteria:

  • Patient previously recruited in The Study of the Prevalence Fibromuscular Dysplasia in Patient With Haematoma or Spontaneous Coronary Artery Dissection. (DISCO trial - NCT02799186) :

    • Patient over 18 years old
    • Patient with a possible diagnosis of spontaneous coronary dissection defined by:
    • ACS presentation
    • Angiographic signs compatible with a SCAD
    • More or less confirmed by intracoronary imaging (OCT/IVUS) or remote angiographic control (upper to 1 month).
    • Patient with signed informed consent to participate in the DISCO study
    • Subject agreeing to the use of his or her personal data in the form of anonymous coding, including in scientific publications.
  • patient who has undergone cardiac rehabilitation following the management of acute coronary syndrome.

Exclusion Criteria:

o Exclusion criteria for the DISCO study :

  • Minor patient
  • Patients of legal age under protective supervision (guardianship, trusteeship)
  • Non affiliation to the French social security system
  • Coronary dissection of iatrogenic or traumatic origin.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Recruited patient .
Patient previsouly recruited in the DISCO Registry (Study of the Prevalence Fibromuscular Dysplasia in Patient With Haematoma or Spontaneous Coronary Artery Dissection. (DISCO trial - NCT02799186)) with cardiac rehabilitation following the management of acute coronary syndrome
Other: Data collection
Specific "Readapt -DISCO" complementary questionnaire rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the cardiac rehabilitation program
Time Frame: day 0 (inclusion)
absence/presence of chest pain during cardiac rehabilitation, hospitalization for a cardiac complication during the rehabilitation program
day 0 (inclusion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Training program modalities
Time Frame: day 0 (inclusion)
Medications changes during cardiac rehabilitation program
day 0 (inclusion)

Collaborators and Investigators

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

Sponsor

University Hospital, Bordeaux

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)

February 5, 2023

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2021/52

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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