Clinical trial NCT05744947: Modalities And Safety Of Cardiac Rehabilitation In A Population Managed For Spontaneous Hematoma Or Coronary Disruption
Official title: Modalities And Safety Of Cardiac Rehabilitation In A Population Managed For Spontaneous Hematoma Or Coronary Disruption (DISCO): Data From The DISCO Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Rehabilitation Program Following the Management of ACS in Patients Presenting With SCAD
Keywords: Cardiac rehabilitation
Spontaneous Coronary Artery Dissection
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient previsouly recruited in the DISCO Registry with cardiac rehabilitation following the management of acute coronary syndrome

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.

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.

Primary outcomes:
measure: Safety of the cardiac rehabilitation program
timeFrame: day 0 (inclusion)
Secondary outcomes:
measure: Training program modalities
timeFrame: day 0 (inclusion)
Other outcomes:
Locations:
city: Annecy
country: France
facility: CH Annecy Genevois
city: Avignon
country: France
facility: CH Henri Duffaut
city: Besançon
country: France
facility: CHU Besançon, Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Bourg-en-Bresse
country: France
facility: Clinique Convert de Bourg en Bresse
city: Caen
country: France
facility: CHU de Caen
city: Cannes
country: France
facility: CH de Cannes
city: Chambéry
country: France
facility: CH Métropole Savoie
city: Chartres
country: France
facility: CH de Chartres
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand
city: Eaubonne
country: France
facility: Hôpital Simone Veil
city: Fontaine-lès-Dijon
country: France
facility: Clinique de Fontaine
city: Grenoble
country: France
facility: CHU de Grenoble Alpes
city: Haguenau
country: France
facility: CH Haguenau
city: La Rochelle
country: France
facility: CHU de la Rochelle
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Hôpital de la Croix Rousse - hospices civils de Lyon
city: Lyon
country: France
facility: Hôpital Louis Pradel - Hospices civils de Lyon
city: Massy
country: France
facility: Hôpital privé Jacques Cartier
city: Metz
country: France
facility: CHR de Metz-Thionville
city: Mulhouse
country: France
facility: GHR Mulhouse et Sud Alsace - Hôpital Emile Muller
city: Nîmes
country: France
facility: C.H.U. de Nîmes
city: Paris
country: France
facility: Hôpital Bichat-Claude-Bernard
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Universitaire de la Pitié-Salpêtrière
city: Rouen
country: France
facility: Clinique Saint-Hilaire
city: Saint-Brieuc
country: France
facility: CH de Saint-Brieuc
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: CHU de Tours-Trousseau
Study officials:
References:
citation: Combaret N, Gerbaud E, Derimay F, Souteyrand G, Cassagnes L, Bouajila S, Berrandou T, Range G, Meneveau N, Harbaoui B, Lattuca B, Bouatia-Naji N, Motreff P. National French registry of spontaneous coronary artery dissections: prevalence of fibromuscular dysplasia and genetic analyses. EuroIntervention. 2021 Aug 27;17(6):508-515. doi: 10.4244/EIJ-D-20-01046.
citation: Combaret N, Liabot Q, Deiri M, Lhermusier T, Boiffard E, Filippi E, Roule V, Georges JL, Manzo-Silberman S, Fluttaz A, Marliere S, Souteyrand G, Pereira B, Cassagnes L, Motreff P. Characteristics and Prognosis of Patients With Fibromuscular Dysplasia in a Population of Spontaneous Coronary Artery Dissections (from the French Registry of Spontaneous Coronary Artery Dissections "DISCO"). Am J Cardiol. 2022 Jul 15;175:38-43. doi: 10.1016/j.amjcard.2022.04.007. Epub 2022 May 11.