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

NCT ID: NCT05744947

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-05

Study Completion Date

2023-04-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Data collection

Intervention Type OTHER

Specific "Readapt -DISCO" complementary questionnaire rehabilitation

Interventions

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Data collection

Specific "Readapt -DISCO" complementary questionnaire rehabilitation

Intervention Type OTHER

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CH Annecy Genevois

Annecy, , France

Site Status RECRUITING

CH Henri Duffaut

Avignon, , France

Site Status RECRUITING

CHU Besançon, Hôpital Jean Minjoz

Besançon, , France

Site Status RECRUITING

CHU de Bordeaux

Bordeaux, , France

Site Status RECRUITING

Clinique Convert de Bourg en Bresse

Bourg-en-Bresse, , France

Site Status RECRUITING

CHU de Caen

Caen, , France

Site Status RECRUITING

CH de Cannes

Cannes, , France

Site Status RECRUITING

CH Métropole Savoie

Chambéry, , France

Site Status RECRUITING

CH de Chartres

Chartres, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Hôpital Simone Veil

Eaubonne, , France

Site Status RECRUITING

Clinique de Fontaine

Fontaine-lès-Dijon, , France

Site Status RECRUITING

CHU de Grenoble Alpes

Grenoble, , France

Site Status RECRUITING

CH Haguenau

Haguenau, , France

Site Status RECRUITING

CHU de la Rochelle

La Rochelle, , France

Site Status RECRUITING

CHU de Limoges

Limoges, , France

Site Status RECRUITING

Hôpital de la Croix Rousse - hospices civils de Lyon

Lyon, , France

Site Status RECRUITING

Hôpital Louis Pradel - Hospices civils de Lyon

Lyon, , France

Site Status RECRUITING

Hôpital privé Jacques Cartier

Massy, , France

Site Status NOT_YET_RECRUITING

CHR de Metz-Thionville

Metz, , France

Site Status RECRUITING

GHR Mulhouse et Sud Alsace - Hôpital Emile Muller

Mulhouse, , France

Site Status NOT_YET_RECRUITING

C.H.U. de Nîmes

Nîmes, , France

Site Status RECRUITING

Hôpital Bichat-Claude-Bernard

Paris, , France

Site Status RECRUITING

Hôpital Lariboisière

Paris, , France

Site Status NOT_YET_RECRUITING

Hôpital Universitaire de la Pitié-Salpêtrière

Paris, , France

Site Status RECRUITING

Clinique Saint-Hilaire

Rouen, , France

Site Status RECRUITING

CH de Saint-Brieuc

Saint-Brieuc, , France

Site Status RECRUITING

CHU de Toulouse

Toulouse, , France

Site Status RECRUITING

CHU de Tours-Trousseau

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Edouard GERBAUD, Dr

Role: CONTACT

524 549 188 ext. +33

Facility Contacts

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Loïc BELLE, Dr

Role: primary

Stéphane ANDRIEU, Dr

Role: primary

Nicolas MENEVEAU, Pr

Role: primary

Edouard GERBAUD, Dr

Role: primary

Hervé DOUARD, Pr

Role: backup

Norbert MAYAUD, Dr

Role: primary

Vincent ROULE, Dr

Role: primary

Laurent BALI, Dr

Role: primary

Arnaud FLUTTAZ, Dr

Role: primary

Grégoire RANGE, Dr

Role: primary

Pascal MOTREFF, Pr

Role: primary

Gaetan KARRILLON, Dr

Role: primary

Philipe BRUNEL, Dr

Role: primary

Stéphanie MARLIERE, Dr

Role: primary

Fabien DEPOLI, Dr

Role: primary

Yann VALY, Dr

Role: primary

Louis LE BIVIC, Dr

Role: primary

Brahim HARBAOUI, Pr

Role: primary

Gilles RIOUFOL, Pr

Role: primary

Hakim BENAMER, Dr

Role: primary

Mathieu VALLA, Dr

Role: primary

Didier BRESSON, Dr

Role: primary

Guillaume CAYLA, Pr

Role: primary

Gregory DUCROCQ, Pr

Role: primary

Stephane MANZO-SILBERMAN, Dr

Role: primary

Johanne SILVAIN, Pr

Role: primary

Matthieu GODIN, Dr

Role: primary

Amer ZABALAWI, Dr

Role: primary

Thibault LHERMUSIER, Dr

Role: primary

Christophe SAINT-ETIENNE, Dr

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 33319763 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35562298 (View on PubMed)

Other Identifiers

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CHUBX 2021/52

Identifier Type: -

Identifier Source: org_study_id

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