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ClinicalTrials.gov ID

NCT05744947

Lead Sponsor

University Hospital, BordeauxOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

90Estimated

Last Update Posted

Mar 1, 2023Actual

Start Date

Feb 5, 2023Actual

Primary Completion Date

Apr 2023Estimated

Completion Date

Apr 2023Estimated

Official Title

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

Brief Summary

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).

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.

• Cardiac Rehabilitation Program Following the Management of ACS in Patients Presenting With SCAD

• Data collection

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Observational Model

Cohort

Time Perspective

Retrospective

Lead Sponsor

University Hospital, BordeauxOTHER

roule-v@chu-caen.fr

laurent.bali@yahoo.fr

fabien.depoli@ch-haguenau.fr;

cayla.guillaume@gmail.com;