Actively Recruiting
A New Cardiac Rehabilitation Treatment in the Application of Ischemic Heart Disease: a Prospective, Randomized Controlled Clinical Study
Led by Shanghai 10th People's Hospital · Updated on 2024-11-08
100
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
S
Shanghai 10th People's Hospital
Lead Sponsor
S
Shanghai Municipal Science and Technology Commission
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new cardiac rehabilitation therapy for patients with ischemic heart disease, including coronary heart disease and heart failure. This prospective, randomized, controlled study aims to compare the effectiveness and home rehabilitation compliance of the new therapy against traditional cardiac rehabilitation. The study follows a PICOST design and focuses on improving myocardial perfusion and other cardiovascular health measures. Participants receive either conventional drug therapy combined with the new cardiac rehabilitation treatment, which includes early respiratory rehabilitation, phase I rehabilitation, exercise therapy, external counterpulsation, and extracorporeal shock wave therapy, or conventional drug therapy combined with traditional cardiac rehabilitation based on national and international guidelines. Treatment duration varies between 1 week and 3 months depending on patient needs. During the study, participants will undergo assessments such as D_SPECT imaging to measure changes in myocardial infarct area over 6 months. Additional evaluations include blood biochemical tests, myocardial necrosis markers, cardiopulmonary exercise testing, and monitoring of major adverse cardiovascular events. Researchers will also track patient and family adherence to rehabilitation treatments to evaluate long-term outcomes and safety.
CONDITIONS
Brief Title
A New Cardiac Rehabilitation Treatment in the Application of Ischemic Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 85 years old
- Female subjects not pregnant
- Main admission diagnosis of ischemic heart disease such as coronary heart disease, myocardial infarction, or ischemic heart failure
- Need for cardiac rehabilitation treatment
You will not qualify if you...
- Acute respiratory distress syndrome (ARDS)
- Acute episode of COPD
- Uncontrolled pulmonary infection
- Acute heart failure or acute pulmonary embolism
- Acute myocarditis or pericarditis
- Severe arrhythmia including degree II or III atrioventricular block, atrial flutter, or atrial fibrillation
- Sternotomy, rib fracture, thoracic deformity, or neurological diseases affecting respiratory muscles
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 3 months
Participants receive routine drug therapy combined with either new cardiac rehabilitation therapy or traditional cardiac rehabilitation therapy according to their assigned group. The rehabilitation includes various phases of exercise, breathing, balance, flexibility, and external therapies tailored to the participant’s condition.
Visits occur according to treatment phases over 1 to 3 months
Duration - 6 months
Participants are followed up to assess myocardial perfusion imaging and other health outcomes including hemodynamic changes and peak oxygen consumption after treatment completion.
At least 1 visit at 6 months after treatment starts
Trial Site Locations
Total: 1 location
1
Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China, 200072
Actively Recruiting
Research Team
L
liujing liu, MD, PhD
Z
zhaoxin zhu, B.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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