About this trial
Cardiac rehabilitation has proven to improve the functional capacity of patients who had acute myocardial infarction. However, its effect on Left ventricular remodeling following an MI event treated with Primary PCI is not yet fully understood. So, for this randomized controlled trial our objectives are as follows:
* Primary: To assess the effect of a structured CR program on LV remodeling parameters (LVEF, LVESV, LVEDV, LVESD, LVEDD + SWMA) in STEMI patients treated with primary PCI. * Secondary: To evaluate changes in exercise capacity, heart rate recovery and clinical outcomes such as major adverse cardiovascular events and the effect of CR on the patients' Quality of Life.
These results will be compared to the same parameters in a control group that will not undergo cardiac rehabilitation to properly assess the effect of cardiac rehab.
Participants in the intervention group will be asked to undergo a supervised CR program based on published guidelines (FITT principle). The core will be a moderate-intensity aerobic exercise regimen (e.g. treadmill or cycle ergometer) 2-3 times per week for 12 weeks. Each session will last \~20-60 minutes of exercise followed by cool-down, with intensity gradually increased to High intensity interval training (HIIT) in low-moderate risk individuals, as it has shown better improvement in cardiovascular health while being safe in MI patients. Resistance exercises (e.g. light weights or band exercises) will also be included twice weekly. Exercise dose (frequency, intensity, time) will be tracked. Physical therapists will supervise all sessions in an outpatient CR facility or affiliated gym. Patients' vitals and ECG will be monitored during initial sessions for safety.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Underwent successful primary PCI within 24 hours of symptom onset.
Hemodynamically stable and able to participate in rehabilitation.
Disqualifiers
Stage IV Heart failure, LVEF < 30%
Life-threatening arrhythmias
Unstable Angina
Severe Valvular Diseases
Trial design
Parallel
Treatments tested in this trial
Cardiac Rehabilitation
Behavioral* The cardiac rehabilitation program include supervised exercise training, patient education, and risk factor modification. * CR starts 1-3 weeks after PCI (based on the patient's general condition) and lasting 12 weeks thereafter. * Patients will undergo a supervised CR program based on published guidelines (FITT principle). The core will be a moderate-intensity aerobic exercise regimen (e.g. treadmill or cycle ergometer) 2-3 times per week for 12 weeks. Each session will last \~20-60 minutes of exercise followed by cool-down, with intensity gradually increased to High intensity interval training (HIIT) in low-moderate risk individuals. Resistance exercises (e.g. light weights or band exercises) will also be included twice weekly. Exercise dose (frequency, intensity, time) will be tracked. Physical therapists will supervise all sessions in an outpatient CR facility or affiliated gym. Patients' vitals and ECG will be monitored during initial sessions for safety.
Primary Percutaneous Coronary Intervention
Procedure/SurgeryPatients will undergo Primary Percutaneous Coronary Intervention (PPCI) within 24 hours of symptom onset for urgent revascularization of the occluded coronary artery.
Treatment groups
Trial outcomes
Primary outcomes
Change in LV remodeling assessed by LV ejection fraction (LVEF)
LVEF assessed in "%"
Change in LV remodeling assessed by LV end-systolic Volume (LVESV), LV end-diastolic Volume (LVEDV)
LVESV and LVEDV are both assessed in mL
Change in LV remodeling assessed by LV end-systolic Diameter (LVESD) and LV end-diastolic Diameter (LVEDD).
LVESD and LVEDD are both assessed in millimeters
Secondary outcomes
Exercise capacity assessed in METs
Heart rate recovery post-exercise.
HRR is measured in BPM
Incidence of MACE during follow-up
Locations
Sponsors and contacts
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