NCT05385341

Brief Summary

Despite a clear indication of grade Ia, cardiac rehabilitation (CR) is dramatically underutilized after acute coronary syndrome with less than 30% of patients addressed in France. Mobile technology has the potential to overcome barriers to access to cardiac rehabilitation and may be a useful tool for increasing participation. However, studies have to prove this type of care is as effective as traditional center based cardiac rehabilitation.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2024

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2020

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
2.5 years until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

1.1 years

First QC Date

April 21, 2020

Last Update Submit

September 23, 2024

Conditions

Acute Coronary Syndrome

Keywords

Cardiac rehabilitationTele-health

Outcome Measures

Primary Outcomes (1)

  • Effect analysis 2 month after inclusion

    Change of the peak oxygen volume at 2 months after inclusion

    2 months

Secondary Outcomes (9)

  • Effect analysis 1 month after inclusion

    1 month

  • Effect analysis 1 month after inclusion

    1 month

  • Effect analysis 2 months after inclusion

    2 months

  • Effect analysis 2 months after inclusion

    2 months

  • Health economics criteria

    26 months

  • +4 more secondary outcomes

Study Arms (2)

Telerehabilitation (Tele RCV)

EXPERIMENTAL

Experimental group (Tele-RCV): the treatment will consist of 20 home-based sessions monitored by the REMOTE-ACS device and containing 2 hours/day 5 days/7 of exercise training (the first session in center to form the patient) associated with 8 educative sessions.

Other: Telerehabilitation (Tele RCV)

Rehabilitation (RCV)

ACTIVE COMPARATOR

Group control (RCV) : 20 sessions of cardiac rehabilitation will be realized in a rehabilitation center containing exercise training during 2 hours/day 5 days/7 and educative program.

Other: Rehabilitation (RCV)

Interventions

Telerehabilitation (Tele RCV)OTHER

20 home-based sessions monitored by the REMOTE-ACS device and containing 2 hours/day 5 days/7 of exercise training associated with educative sessions.

Telerehabilitation (Tele RCV)
Rehabilitation (RCV)OTHER

20 sessions of cardiac rehabilitation will be realized in a rehabilitation center containing exercise training during 2 hours/day 5 days/7 and educative program.

Rehabilitation (RCV)

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with acute coronary syndrome less than 6 months,
  • Addressed to ambulatory cardiac rehabilitation,
  • Equipped with a smartphone compatible with the protocol's application, connected to web
  • Having signed an informed consent,
  • Affiliated to the french national health insurance.

You may not qualify if:

  • Incapacity to use application on smartphone,
  • Contraindication to exercise training,
  • Pregnancy,
  • Juridic protection
  • Left ventricular ejection fraction \< 45%
  • Significate ventricular arrhythmia (frequent or polymorph PVC during initial exercise testing, ventricular tachycardia or sudden cardiac death at the beginning)
  • Flutter or atrial fibrillation (transient or permanent)
  • Coronary revascularization needing supplementary procedure
  • Residual myocardial ischemia determined by initial exercise testing or alternative testing (nuclear imaging or stress echocardiography)
  • Mini Mental State \< 26
  • Patients living alone at home
  • Comorbidities limiting participation to the protocol: kidney dialysis, insulin-requiring diabetes, residuals sequels of central and/or peripheral nervous system injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

TelerehabilitationRehabilitationRacivir

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Meyer ELBAZ, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2020

First Posted

May 23, 2022

Study Start

December 1, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share