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

Endovascular intervention is one of the most effective treatment for acute coronary syndrome. Therefore, studying the impact of various medical rehabilitation programs on the course of coronary heart disease, patient quality of life, restenosis, and prognosis is of scientific and practical interest. Medical rehabilitation is a crucial stage in patient care after myocardial revascularization. Regular moderate-intensity physical activity helps improve endothelial function and has anti-inflammatory and antithrombogenic effects. Improving a patient's prognosis after myocardial infarction depends on the duration and intensity of cardiac rehabilitation programs, as well as the patient's motivation. Therefore, this issue requires further study, particularly in patients who have undergone endovascular interventions on coronary arteries.

Study Overview

Status

Active, not recruiting

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

Interventional

Enrollment (Actual)

1046

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Acute myocardial infarction, coronary artery stenting

Exclusion Criteria:

  • Age (younger 18 years, older 75 years)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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