Remote Exercise SWEDEHEART Study

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    1500
  • sponsor
    Sahlgrenska University Hospital, Sweden
Updated on 19 February 2024
myocardial infarction
infarct
cardiac rehabilitation
acute myocardial infarction

Summary

This study evaluates if remote video exercise-based cardiac rehabilitation (exCR), offered as an alternative to centre-based exCR, can increase the proportion of patients post myocardial infarction (MI) successfully completing an exCR-program.

Description

Primary aim is to evaluate if remote video exCR, offered as an alternative to centre-based exCR, can increase the proportion of patients post myocardial infarction (MI) successfully completing an exCR-program.

Secondary aims are to investigate if remote video exCR is at least as effective as centre-based exCR, in terms of physical fitness, patient-reported outcome measures (PROMs) and cost-effectiveness. Follow-up of cardiovascular events (all-cause mortality, cardiovascular mortality, recurrent hospitalization for acute coronary syndrome (ACS), heart failure and stroke, and repeat coronary revascularization) will be performed.

CR centers (not patients) will be cluster randomized to either the intervention or control. Patients at intervention centers will be offered remote video exCR or usual care centre-based exCR, as self-preferred choice. At control centers, patients will be offered usual care centre-based exCR only. The duration of each time period for each center will be approximately 15 months.

A number of 1500 of eligible patients post MI, meeting the inclusion and exclusion criteria over a period of approximately three years.

Details
Condition Myocardial Infarction, Ischemic Heart Disease
Age 18-79 years
Treatment Exercise-based cardiac rehabilitation
Clinical Study IdentifierNCT04260958
SponsorSahlgrenska University Hospital, Sweden
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent
Diagnosis of acute myocardial infarction (AMI)
Age 18-79 years at discharge from hospital

Exclusion Criteria

Patients with incomplete coronary revascularization defined as at least one remaining hemodynamically significant stenosis
Severe valve or structural heart disease
Severe heart failure (NYHA IIIb - IV)
Inability to understand Swedish
No internet access at home (only applicable for intervention group)
Any condition that may interfere with the possibility for the patient to comply with the study protocol
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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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