Impact of early cardiac rehabilitation on heart attack recovery

The Impact of Phase I Cardiac Rehabilitation on the Prognosis of Acute Myocardial Infarction (AMI) Patients After Percutaneous Coronary Intervention (PCI): A Single-Center, Randomized Controlled Study

This study is testing if starting heart rehab just a few days after a heart attack can help patients recover better and feel good a year later.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shenyang Northern Hospital (Academic / other)
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT06406218 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of Phase I cardiac rehabilitation initiated within three days after percutaneous coronary intervention (PCI) in patients who have experienced an acute myocardial infarction (AMI). The primary goal is to determine if this early rehabilitation can enhance long-term prognosis, measured by the Seattle Angina Questionnaire (SAQ) score at 12 months. Patients will be compared to a control group to assess the effectiveness of the rehabilitation program. The study aims to fill a gap in existing research regarding the timing and benefits of cardiac rehabilitation post-PCI.

Who should consider this trial

Good fit: Ideal candidates include patients who have experienced an AMI and are stable after PCI without complications.

Not a fit: Patients with severe complications or significant comorbidities that prevent participation in rehabilitation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery outcomes and quality of life for heart attack patients after PCI.

How similar studies have performed: Previous studies have shown positive outcomes for cardiac rehabilitation after PCI, but this specific timing and approach is less explored.

Eligibility criteria

Inclusion Criteria:

1. Patients with AMI (including STEMI and NSTEMI) who were treated in the CCU (Coronary Care Unit) for more than 12 hours after emergency PCI;
2. Patients who are expected to meet the discharge criteria without the need for repeat PCI during the current hospital stay after PCI;
3. No chest pain episodes within 8 hours, with no recurrence of myocardial infarction; remained hemodynamically stable;
4. No further increase in serum levels of cardiac biomarkers such as Creatine Kinase -MB (CK-MB) and cardiac troponins (cTn).

Exclusion Criteria:

1. Patients with Killip class III or higher, or symptoms and signs of acute pulmonary edema and respiratory distress;
2. Malignant arrhythmias that cause hemodynamic instability and potentially life-threatening conditions;
3. Mechanical lesions such as ventricular wall rupture, valve or tendon rupture;
4. Patients who have not yet been weaned off ECMO, IABP, temporary pacemakers, CRRT;
5. Patients with liver or kidney dysfunction (transaminase exceeded three times the upper limit of normal; EGFR\<30 ml/(min·1.73m\^2)) or advanced malignant tumors;
6. Patients who cannot undergo exercise rehabilitation due to orthopedic or psychiatric diseases;
7. Patients with language impairment;
8. Patients currently undergoing systematic training or participating in other clinical trials without reaching the primary endpoint collection time;
9. Researchers believe that patients are not suitable for participation in this study or have not obtained an informed consent form.

Where this trial is running

Shenyang, Liaoning

• General Hospital of Northern Theater Command — Shenyang, Liaoning, China (Recruiting)

Study contacts

• Principal investigator: Ya-Ling Han, PhD — Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China
• Study coordinator: Ya-Ling Han, PhD

Conditions Acute Myocardial Infarction; Phase I Cardiac Rehabilitation