Cardiac Rehabilitation Program Following the Management of ACS in Patients Presenting With SCADREADAPT-DISCONCT05744947
Modalities And Safety Of Cardiac Rehabilitation In A Population Managed For Spontaneous Hematoma Or Coronary Disruption
An observational study of Cardiac Rehabilitation Program Following the Management of ACS in Patients Presenting With SCAD, run by University Hospital, Bordeaux at 29 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation Program Following the Management of ACS in Patients Presenting With SCAD
- What is being tested?
- Data collection
- How many people
- 90 participants
- Where
- 29 sitesFrance
- Study dates
- 5 Feb 2023to Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient previsouly recruited in the DISCO Registry with cardiac rehabilitation following the management of acute coronary syndrome
Who may be able to join
- 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).
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
France29 sites, 29 recruiting
- Recruiting
CH Annecy Genevois
Annecy
Loïc BELLE, Dr, lbelle@ch-annecygenevois.fr
- Recruiting
CH Henri Duffaut
Avignon
Stéphane ANDRIEU, Dr, sandrieu@ch-avignon.fr
- Recruiting
CHU Besançon, Hôpital Jean Minjoz
Besançon
Nicolas MENEVEAU, Pr, nicolas.meneveau@univ-fcomte.fr
- Recruiting
CHU de Bordeaux
Bordeaux
Edouard GERBAUD, Dr, edouard.gerbaud@chu-bordeaux.fr
Hervé DOUARD, Pr, herve.douard@chu-bordeaux.fr
- Recruiting
Clinique Convert de Bourg en Bresse
Bourg-en-Bresse
Norbert MAYAUD, Dr, norbert.mayaud@orange.fr ,
- Recruiting
CHU de Caen
Caen
Vincent ROULE, Dr, roule-v@chu-caen.fr
- Recruiting
CH de Cannes
Cannes
Laurent BALI, Dr, laurent.bali@yahoo.fr
- Recruiting
CH Métropole Savoie
Chambéry
Arnaud FLUTTAZ, Dr, arnaud.fluttaz@ch-metropole-savoie.fr
- Recruiting
CH de Chartres
Chartres
Grégoire RANGE, Dr, grange@ch-chartres.fr
- Recruiting
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63000
Pascal MOTREFF, Pr, pmotreff@chu-clermontferrand.fr
- Recruiting
Hôpital Simone Veil
Eaubonne
Gaetan KARRILLON, Dr, gaetan.karrillon@ch-simoneveil.fr
- Recruiting
Clinique de Fontaine
Fontaine-lès-Dijon
Philipe BRUNEL, Dr, phlppbrunel@gmail.com
- Recruiting
CHU de Grenoble Alpes
Grenoble
Stéphanie MARLIERE, Dr, smarliere@chu-grenoble.fr;
- Recruiting
CH Haguenau
Haguenau
Fabien DEPOLI, Dr, fabien.depoli@ch-haguenau.fr;
- Recruiting
CHU de la Rochelle
La Rochelle
Yann VALY, Dr, Yann.valy@ch-larochelle.fr
- Recruiting
CHU de Limoges
Limoges
Louis LE BIVIC, Dr, louis.lebivic87@gmail.com
- Recruiting
Hôpital de la Croix Rousse - hospices civils de Lyon
Lyon
Brahim HARBAOUI, Pr, brahim.harbaoui@chu-lyon.fr
- Recruiting
Hôpital Louis Pradel - Hospices civils de Lyon
Lyon
Gilles RIOUFOL, Pr, gilles.rioufol@univ-lyon1.fr
- Not yet recruiting
Hôpital privé Jacques Cartier
Massy
Hakim BENAMER, Dr, h.benamer@angio-icps.com
- Recruiting
CHR de Metz-Thionville
Metz
Mathieu VALLA, Dr, m.valla@chr-metz-thionville.fr
- Not yet recruiting
GHR Mulhouse et Sud Alsace - Hôpital Emile Muller
Mulhouse
Didier BRESSON, Dr, didier.bresson@ch-mulhouse.fr
- Recruiting
C.H.U. de Nîmes
Nîmes
Guillaume CAYLA, Pr, cayla.guillaume@gmail.com;
- Recruiting
Hôpital Bichat-Claude-Bernard
Paris
Gregory DUCROCQ, Pr, gregory.ducrocq@aphp.fr
- Not yet recruiting
Hôpital Lariboisière
Paris
Stephane MANZO-SILBERMAN, Dr, stephane.manzosilberman@aphp.fr
- Recruiting
Hôpital Universitaire de la Pitié-Salpêtrière
Paris
Johanne SILVAIN, Pr, johanne.silvain@aphp.fr
- Recruiting
Clinique Saint-Hilaire
Rouen
Matthieu GODIN, Dr, mgodin@clinique-sainthilaire.fr;
- Recruiting
CH de Saint-Brieuc
Saint-Brieuc
Amer ZABALAWI, Dr, amer.zabalawi@ch-stbrieuc.fr;
- Recruiting
CHU de Toulouse
Toulouse
Thibault LHERMUSIER, Dr, lhermusier.t@chu-toulouse.fr
- Recruiting
CHU de Tours-Trousseau
Tours
Christophe SAINT-ETIENNE, Dr, C.SAINTETIENNE@chu-tours.fr
About this study
Official title: Modalities And Safety Of Cardiac Rehabilitation In A Population Managed For Spontaneous Hematoma Or Coronary Disruption (DISCO): Data From The DISCO Study
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).
Read the 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.
- Conditions
- Cardiac Rehabilitation Program Following the Management of ACS in Patients Presenting With SCAD
- Being tested
- Data collection
- Keywords
- Cardiac rehabilitation, Spontaneous Coronary Artery Dissection
- Medical subject headings
- Coronary Artery Dissection, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Specific "Readapt -DISCO" complementary questionnaire rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the cardiac rehabilitation program
absence/presence of chest pain during cardiac rehabilitation, hospitalization for a cardiac complication during the rehabilitation program
Measured: day 0 (inclusion)
Secondary outcomes (1)
Training program modalities
Medications changes during cardiac rehabilitation program
Measured: day 0 (inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start5 Feb 2023
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac Rehabilitation Program Following the Management of ACS in Patients Presenting With SCADStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744947
- Sponsor's protocol ID
- CHUBX 2021/52
- Acronym
- READAPT-DISCO
- Status last verified
- Feb 2023
- First submitted
- 15 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33319763Combaret 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.
PubMed 35562298
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modalities And Safety Of Cardiac Rehabilitation In A Population Managed For Spontaneous Hematoma Or Coronary Disruption (DISCO): Data From The DISCO Study
- ClinicalTrials.gov ID
- NCT05744947
- Acronym / sponsor ID
- READAPT-DISCO / CHUBX 2021/52
- Conditions
- Cardiac Rehabilitation Program Following the Management of ACS in Patients Presenting With SCAD
- Keywords
- Cardiac rehabilitation, Spontaneous Coronary Artery Dissection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recruited patient . | – | Other: Data collectionPatient 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient previsouly recruited in the DISCO Registry with cardiac rehabilitation following the management of acute coronary syndrome
Key inclusion criteria (9 listed)
- Patient previously recruited in The Study of the Prevalence Fibromuscular Dysplasia in Patient With Haematoma or Spontaneous Coronary Artery Dissection. (DISCO trial - NCT02799186) :
- patient who has undergone cardiac rehabilitation following the management of acute coronary syndrome.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionSpecific "Readapt -DISCO" complementary questionnaire rehabilitation | Other | Recruited patient . |
Primary outcome
Safety of the cardiac rehabilitation program
Time frame: day 0 (inclusion)
absence/presence of chest pain during cardiac rehabilitation, hospitalization for a cardiac complication during the rehabilitation program
1 secondary outcome
Training program modalities
Time frame: day 0 (inclusion)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 33319763Combaret 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.
- Background: PubMed 35562298Combaret 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Rehabilitation Program Following the Management of ACS in Patients Presenting With SCAD, run by University Hospital, Bordeaux at 29 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edouard GERBAUD, Dr (524 549 188 ext. +33, edouard.gerbaud@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the cardiac rehabilitation program (time frame: day 0 (inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05744947, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.