NCT05744947

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

29 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

February 15, 2023

Last Update Submit

February 28, 2023

Conditions

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

Keywords

Cardiac rehabilitationSpontaneous Coronary Artery Dissection

Outcome Measures

Primary Outcomes (1)

  • Safety of the cardiac rehabilitation program

    absence/presence of chest pain during cardiac rehabilitation, hospitalization for a cardiac complication during the rehabilitation program

    day 0 (inclusion)

Secondary Outcomes (1)

  • Training program modalities

    day 0 (inclusion)

Study Arms (1)

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

Interventions

Data collectionOTHER

Specific "Readapt -DISCO" complementary questionnaire rehabilitation

Recruited patient .

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

CH Annecy Genevois

Annecy, France

RECRUITING

CH Henri Duffaut

Avignon, France

RECRUITING

CHU Besançon, Hôpital Jean Minjoz

Besançon, France

RECRUITING

CHU de Bordeaux

Bordeaux, France

RECRUITING

Clinique Convert de Bourg en Bresse

Bourg-en-Bresse, France

RECRUITING

CHU de Caen

Caen, France

RECRUITING

CH de Cannes

Cannes, France

RECRUITING

CH Métropole Savoie

Chambéry, France

RECRUITING

CH de Chartres

Chartres, France

RECRUITING

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

Hôpital Simone Veil

Eaubonne, France

RECRUITING

Clinique de Fontaine

Fontaine-lès-Dijon, France

RECRUITING

CHU de Grenoble Alpes

Grenoble, France

RECRUITING

CH Haguenau

Haguenau, France

RECRUITING

CHU de la Rochelle

La Rochelle, France

RECRUITING

CHU de Limoges

Limoges, France

RECRUITING

Hôpital de la Croix Rousse - hospices civils de Lyon

Lyon, France

RECRUITING

Hôpital Louis Pradel - Hospices civils de Lyon

Lyon, France

RECRUITING

Hôpital privé Jacques Cartier

Massy, France

NOT YET RECRUITING

CHR de Metz-Thionville

Metz, France

RECRUITING

GHR Mulhouse et Sud Alsace - Hôpital Emile Muller

Mulhouse, France

NOT YET RECRUITING

C.H.U. de Nîmes

Nîmes, France

RECRUITING

Hôpital Bichat-Claude-Bernard

Paris, France

RECRUITING

Hôpital Lariboisière

Paris, France

NOT YET RECRUITING

Hôpital Universitaire de la Pitié-Salpêtrière

Paris, France

RECRUITING

Clinique Saint-Hilaire

Rouen, France

RECRUITING

CH de Saint-Brieuc

Saint-Brieuc, France

RECRUITING

CHU de Toulouse

Toulouse, France

RECRUITING

CHU de Tours-Trousseau

Tours, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 33319763BACKGROUND

  • 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.

    PMID: 35562298BACKGROUND

MeSH Terms

Conditions

Coronary Artery Dissection, Spontaneous

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Edouard GERBAUD, Dr

CONTACT

524 549 188edouard.gerbaud@chu-bordeaux.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2023

First Posted

February 27, 2023

Study Start

February 5, 2023

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations

FR(29)