The Impact of Phase I Cardiac Rehabilitation on the Prognosis of AMI Patients After PCI

Last updated: May 5, 2024
Sponsor: Han Yaling, MD
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Blood Clots

Angina

Treatment

Phase I Cardiac Rehabilitation Exercise Training

Clinical Study ID

NCT06406218
AID
  • Ages > 18
  • All Genders

Study Summary

Previous research has confirmed that patients undergoing percutaneous coronary intervention (PCI) can benefit from cardiac rehabilitation programs. However, there is a paucity of studies on Phase I cardiac rehabilitation commenced within three days following PCI in patients with acute myocardial infarction (AMI). Consequently, the objective of the study is to demonstrate whether Phase I cardiac rehabilitation can improve the prognosis at 12 months when compared with the control group. The primary endpoint is the Seattle Angina Questionnaire (SAQ) score at 12 months for the patients. The principal hypothesis of the study is that Phase I cardiac rehabilitation will improve the long-term prognosis for AMI patients at 12 months after PCI.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with AMI (including STEMI and NSTEMI) who were treated in the CCU (CoronaryCare Unit) for more than 12 hours after emergency PCI;
  2. Patients who are expected to meet the discharge criteria without the need for repeatPCI 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

Exclusion Criteria:

  1. Patients with Killip class III or higher, or symptoms and signs of acute pulmonaryedema and respiratory distress;
  2. Malignant arrhythmias that cause hemodynamic instability and potentiallylife-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 upperlimit of normal; EGFR<30 ml/(min·1.73m^2)) or advanced malignant tumors;
  6. Patients who cannot undergo exercise rehabilitation due to orthopedic or psychiatricdiseases;
  7. Patients with language impairment;
  8. Patients currently undergoing systematic training or participating in other clinicaltrials without reaching the primary endpoint collection time;
  9. Researchers believe that patients are not suitable for participation in this study orhave not obtained an informed consent form.

Study Design

Total Participants: 1100
Treatment Group(s): 1
Primary Treatment: Phase I Cardiac Rehabilitation Exercise Training
Phase:
Study Start date:
April 24, 2024
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning 110016
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.