The Effect of Cardiac Rehabilitation on Left Ventricular Remodeling in Patients Undergoing Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction

NCT07155928 | Not Yet Recruiting

• 1 other identifier: CR on LV Remod in PPCI Pt
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Myocardial Infarction (AMI); PCI Patients; Percutaneous Coronary Intervention (PCI); Primary Percutaneous Coronary Intervention; Left Ventricle Remodeling

Keywords

Cardiac Rehabilitation; Acute Myocardial Infarction; Primary Percutaneous Coronary Intervention; Left Ventricular Remodeling; Ejection fraction; End-systolic volume; End-systolic diameter; End-diastolic volume; End-diastolic diameter; Functional capacity; Aerobic exercise; Resistance Training

Outcome Measures

Primary Outcomes (3)

• Change in LV remodeling assessed by LV ejection fraction (LVEF)

  LVEF assessed in "%"

  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

  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

  Before and after a 3-month cardiac rehabilitation program

Secondary Outcomes (3)

• Exercise capacity assessed in METs

  Before and after a 3-month cardiac rehabilitation program

• Heart rate recovery post-exercise.

  Before and after a 3-month cardiac rehabilitation program

• Incidence of MACE during follow-up

  Throughout the 3 month CR program

Study Arms (2)

Intervention Group

EXPERIMENTAL

Standard Treatment + Cardiac Rehabilitation

Behavioral: Cardiac Rehabilitation; Procedure: Primary Percutaneous Coronary Intervention

Control Group

ACTIVE COMPARATOR

Standrad Treatment Only

Procedure: Primary Percutaneous Coronary Intervention

Interventions

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.

Intervention Group

Primary Percutaneous Coronary Intervention PROCEDURE

Patients will undergo Primary Percutaneous Coronary Intervention (PPCI) within 24 hours of symptom onset for urgent revascularization of the occluded coronary artery.

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Underwent successful primary PCI within 24 hours of symptom onset.
• Hemodynamically stable and able to participate in rehabilitation.

You may not qualify if:

• Stage IV Heart failure, LVEF \< 30%
• Life-threatening arrhythmias
• Unstable Angina
• Severe Valvular Diseases
• Uncontrolled Hypertension
• CKD Stages IV and V
• Hypothyroidism
• Cardiomyopathy
• Inability to ambulate or consent

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• Soleimannejad K, Nouzari Y, Ahsani A, Nejatian M, Sayehmiri K. Evaluation of the effect of cardiac rehabilitation on left ventricular diastolic and systolic function and cardiac chamber size in patients undergoing percutaneous coronary intervention. J Tehran Heart Cent. 2014;9(2):54-8.

  PMID: 25861319 BACKGROUND

• Scalvini S, Zanelli E, Comini L, Dalla Tomba M, Troise G, Febo O, Giordano A. Home-based versus in-hospital cardiac rehabilitation after cardiac surgery: a nonrandomized controlled study. Phys Ther. 2013 Aug;93(8):1073-83. doi: 10.2522/ptj.20120212. Epub 2013 Apr 18.

  PMID: 23599353 BACKGROUND

• Qi Z, Zheng Y, Chan JSK, Tse G, Liu T. Exercise-based cardiac rehabilitation for left ventricular function in patients with heart failure: A systematic review and meta-analysis. Curr Probl Cardiol. 2024 Feb;49(2):102210. doi: 10.1016/j.cpcardiol.2023.102210. Epub 2023 Nov 20.

  PMID: 37993005 BACKGROUND

• Mahmoud, S. Y. Z., Mohamed Ahmed; Alamin, Ali Mohamed; Yassin, Ibrahim Abdel-Fattah; and Hassaan, Ahmad Mohammad (2024) (2024). Effect of Cardiac Rehabilitation on Left Ventricular Remodeling After Acute Anterior Wall ST Segment Elevation Myocardial Infarction Treated by Late PCI Using 3D Echocardiography: A Randomized Study. Al-Azhar International Medical Journal, 33. https://doi.org/DOI: https://doi.org/10.58675/2682-339X.2235

  BACKGROUND

• Dubach P, Myers J, Dziekan G, Goebbels U, Reinhart W, Vogt P, Ratti R, Muller P, Miettunen R, Buser P. Effect of exercise training on myocardial remodeling in patients with reduced left ventricular function after myocardial infarction: application of magnetic resonance imaging. Circulation. 1997 Apr 15;95(8):2060-7. doi: 10.1161/01.cir.95.8.2060.

  PMID: 9133516 BACKGROUND

• Ahmed Galal A. Fattah Fahmy MD , Gamal Abdel Hady MD , M. H. H., MD , K. M. M. M. a., & MD, M. E. B. (2021). Continuous Moderate Exercise Influence on Cardiac Remodeling in Patients Underwent Percutaneous Coronary Intervention. SciVision.

  BACKGROUND

MeSH Terms

Conditions

Ventricular Remodeling

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Hamdy Shams Eddin Mohammad Taher, MD

  Assiut University

  STUDY CHAIR

• Magdy Ibrahim Aldesowky Mohamed Algowhary, MD

  Assiut University

  STUDY CHAIR

Central Study Contacts

Muhammad Hatem Maghraby, Bachelor's

CONTACT

+201014321553; Mohamed.17289566@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Prospective, Randomized Control Trial including 2 Parallel Groups

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: September 4, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-08