- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07465692
Long-term Results of Rehabilitation of Patients With Myocardial Infarction After Coronary Artery Stenting. The Register.
Long-term Results of Rehabilitation of Patients With Myocardial Infarction After Endovascular Intervention on Coronary Arteries at the Outpatient Stage. Register
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study was an interventional (clinical) trial, randomized in parallel groups. A total of 1,046 patients were included.
A total of 1,046 patients of both sexes were randomized into two groups. Group 1 (control) patients received standard therapy required for patients undergoing coronary artery stenting during the acute phase of myocardial infarction. They continued their usual physical activity and attended a school for patients with myocardial infarction. Group 2 patients received standard therapy required for patients undergoing coronary artery stenting during the acute phase of myocardial infarction, attended a school for patients with myocardial infarction, and participated in a physical training program. The training program lasted over four months. Postoperatively, patients underwent blood tests, echocardiography, ECG, and bicycle ergometry. The next visit was performed after an average of eight years (with a maximum follow-up period of 11 years). Cardiovascular events were assessed at this stage. Patients who were unable to attend the clinic were interviewed by telephone.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Acute myocardial infarction, coronary artery stenting
Exclusion Criteria:
- Age (younger 18 years, older 75 years)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physical training
Integrated Rehabilitation consisting of exercise training and school for patients
|
Integrated Rehabilitation consisting of exercise training for at least 1.5 months
|
|
No Intervention: Control
Standard follow-up and attending school for patients at the participating heart center
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Combined
Time Frame: 20 years
|
Cardiovascular mortality, non-fatal acute myocardial infarction, non-fatal stroke, need for revascularization
|
20 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All-cause mortality
Time Frame: 20 years
|
20 years
|
|
|
Composite endpoint of major adverse cardiovascular events (MACE)
Time Frame: 20 years
|
Composite endpoint of major adverse cardiovascular events (MACE), defined as the first occurrence of any of the following: recurrent myocardial infarction, ischemic or hemorrhagic stroke, repeat coronary revascularization (PCI or CABG), cardiovascular death.
|
20 years
|
|
cardiovascular mortality
Time Frame: 20 years
|
20 years
|
|
|
myocardial infarction
Time Frame: 20 years
|
20 years
|
|
|
stroke
Time Frame: 20 years
|
20 years
|
|
|
need for revascularization
Time Frame: 20 years
|
20 years
|
|
|
hospitalization due to cardiovascular complications
Time Frame: 20 years
|
20 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCRAS07-01/13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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