An interventional study of Cardiac Rehabilitation and Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction (AMI), PCI Patients and Percutaneous Coronary Intervention (PCI), sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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:
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.
ST-segment elevation myocardial infarction (STEMI) remains a leading cause of morbidity and mortality worldwide. Primary percutaneous coronary intervention (PCI) is the gold standard for reperfusion therapy in STEMI, significantly improving survival rates. However, adverse left ventricular (LV) remodeling post-STEMI can lead to heart failure, poor clinical outcomes and deterioration in patients' quality of life.
Cardiac rehabilitation (CR) is a multidisciplinary intervention designed to optimize cardiovascular recovery. It involves a spectrum of interventions including a structured exercise program, patient education, nutritional counseling, risk factor modification and psychosocial support. CR is divided into 4 stages. Stage I is in-hospital exercise (early mobilization and patient education). Stage II is early outpatient supervised rehabilitation in rehabilitation centers lasting 3 months post-PCI. Stage III starts at 3-12 months and is usually home-based rehabilitation with frequent visits to rehabilitation centers. Stage IV is long term rehab where the patient continues to exercise and commit to a healthy lifestyle to prevent further episodes of cardiovascular disease. Research has shown that stage II is the most crucial of them all, and starting during early in-hospital setting has shown no further improvement in cardiovascular health.
Exercise-based programs, have especially shown beneficial effects on LV function post-AMI, improving exercise capacity and potentially limiting adverse remodeling process. It has been reported that supervised exercise training after STEMI significantly increased LVEF and reduced the rate of unfavorable remodeling at 6 months compared to usual care.
Moreover, there was a significant reduction in post-treatment LV mass, EF, and LV dimensions relative to pretreatment. It has also been suggested that early initiation of CR may reduce systemic inflammation and promote favorable ventricular remodeling.
However, other studies have shown that CR may not have a clinically significant improvement in LV parameters despite the overall improvement in patient's exercise capacity , but these studies were performed with a small sample size. Other trials have shown mixed results, with some showing favorable remodeling after exercise therapy, and some showing no improvement in cardiac dimensions. Another study mentioned that CR may have a positive effect on LV diastolic dysfunction, without any change to LV dimensions.
As such, the exact impact of CR on LV remodeling specifically in primary PCI-treated STEMI patients requires further clarification, especially with recent evidence highlighting its potential benefits.
Such controversy provides adequate foundation to further research this topic with a larger sample size, inclusion of both sexes, with individualization of exercise protocols based on each patient's tolerance.
105 studies on the registry are indexed under Ventricular Remodeling; 24 are open to participants now.
This study's planned enrollment of 100 is above the median of 81 across 72 interventional studies indexed under Ventricular Remodeling.
Browse Ventricular Remodeling studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard Treatment + Cardiac Rehabilitation
Behavioral: Cardiac Rehabilitation · Procedure: Primary Percutaneous Coronary Intervention
Standrad Treatment Only
Procedure: Primary Percutaneous Coronary Intervention
* 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.
Patients will undergo Primary Percutaneous Coronary Intervention (PPCI) within 24 hours of symptom onset for urgent revascularization of the occluded coronary artery.
Change in LV remodeling assessed by LV ejection fraction (LVEF)
LVEF assessed in "%"
Time frame: Before and after a 3-month cardiac rehabilitation program
Change in LV remodeling assessed by LV end-systolic Volume (LVESV), LV end-diastolic Volume (LVEDV)
LVESV and LVEDV are both assessed in mL
Time frame: Before and after a 3-month cardiac rehabilitation program
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
Time frame: Before and after a 3-month cardiac rehabilitation program
Exercise capacity assessed in METs
Time frame: Before and after a 3-month cardiac rehabilitation program
Heart rate recovery post-exercise.
HRR is measured in BPM
Time frame: Before and after a 3-month cardiac rehabilitation program
Incidence of MACE during follow-up
Time frame: Throughout the 3 month CR program
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This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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