Clinical trial NCT06406218: The Impact of Phase I Cardiac Rehabilitation on the Prognosis of AMI Patients After PCI
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Myocardial Infarction
Phase I Cardiac Rehabilitation
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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.

Primary outcomes:
measure: Seattle Angina Questionnaire (SAQ)
timeFrame: 6-month and 12-month
Secondary outcomes:
measure: 6 minutes walking distance
timeFrame: 6-month and 12-month
measure: Left ventricular ejection fraction
timeFrame: 6-month
measure: MACCE
timeFrame: 12-month
Other outcomes:
Locations:
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
Study officials:
affiliation: Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China
name: Ya-Ling Han, PhD
role: PRINCIPAL_INVESTIGATOR
References: