Modalities And Safety Of Cardiac Rehabilitation In A Population Managed For Spontaneous Hematoma Or Coronary Disruption

Recruiting

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

• Registration Number: NCT05744947
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-05
• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-27
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01
• Primary Completion: 2023-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of the cardiac rehabilitation program	day 0 (inclusion)	absence/presence of chest pain during cardiac rehabilitation, hospitalization for a cardiac complication during the rehabilitation program

Secondary Outcome Measures

Name	Time	Method
Training program modalities	day 0 (inclusion)	Medications changes during cardiac rehabilitation program

Trial Locations

Locations (29)

CH Annecy Genevois; 🇫🇷 Annecy, France

CH Henri Duffaut; 🇫🇷 Avignon, France

CHU Besançon, Hôpital Jean Minjoz; 🇫🇷 Besançon, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Clinique Convert de Bourg en Bresse; 🇫🇷 Bourg-en-Bresse, France

CHU de Caen; 🇫🇷 Caen, France

CH de Cannes; 🇫🇷 Cannes, France

CH Métropole Savoie; 🇫🇷 Chambéry, France

CH de Chartres; 🇫🇷 Chartres, France

Centre Hospitalier Universitaire de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

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