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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myocardial Infarction; Phase I Cardiac Rehabilitation
• Intervention / Treatment: Behavioral: Phase I Cardiac Rehabilitation Exercise Training

• Study Type: Interventional
• Enrollment (Estimated): 1100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ya-Ling Han, PhD; Phone Number: +86 024-28897309; Email: hanyaling@263.net

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110016
      • Recruiting
      • General Hospital of Northern Theater Command
      • Contact: Ya-Ling Han, PhD; Phone Number: +86 024-28897309; Email: hanyaling@263.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase I Cardiac Rehabilitation Exercise Training	Behavioral: Phase I Cardiac Rehabilitation Exercise Training; A) In the morning, take a supine position and perform straight leg raises with each leg individually, lifting to a height of 30° and holding for 3-5 seconds. Raise both arms to the side of the head to a 90° angle and hold for 5-10 seconds. Inhale deeply when exerting force and exhale slowly when lowering. Alternate between leg lifts and arm raises, performing 5 sets per session. Adjust intensity based on individual condition and may be repeated. In the afternoon, sit beside the bed for 5 minutes. B) After transitioning to secondary care according to the patient's condition, stand beside the bed for 5 minutes in the morning; in the afternoon, march in place beside the bed for 5 minutes. C) Walk beside the bed for 10 minutes per session, twice a day. D) Move around and doing activities under supervision inside the ward, 10 minutes per session, twice a day. Spend approximately one day at each level, gradually progressing the exercise to the patient's tolerance level.
No Intervention: Guideline control; During hospitalization, patients assigned to the guideline control only receive routine medication treatment according to the guidelines, without any exercise intervention or education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seattle Angina Questionnaire (SAQ)	Seattle Angina Questionnaire Score (from 0 to 500) higher scores mean a better outcome. The assessment consists of five specific dimensions, with each dimension scored on a scale ranging from 0 to 100.; Degree of physical activity limitation.; Stable angina status.; Frequency of angina attacks.; Satisfaction with treatment.; Level of disease awareness.	6-month and 12-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minutes walking distance		6-month and 12-month
Left ventricular ejection fraction	The percentage of the left ventricular stroke volume relative to the left ventricular end-diastolic volume(%).	6-month
MACCE	All-cause death, myocardial infarction, stroke, revascularization again	12-month

Collaborators and Investigators

• Sponsor: Han Yaling, MD
• Investigators: Principal Investigator: Ya-Ling Han, PhD, Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: May 5, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 5, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: AID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No