Clinical trial NCT06681506: A New Cardiac Rehabilitation Treatment in the Application of Ischemic Heart Disease
Official title: A New Cardiac Rehabilitation Treatment in the Application of Ischemic Heart Disease: a Prospective, Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Heart Disease
Cardiac Rehabilitation
Keywords: coronary atherosclerotic cardiopathy
Cardiac Shock Wave Therapy
exercise rehabilitation
cardiac rehabilitation
Ischemic Heart Disease
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Municipal Science and Technology Commission
First posted: 2024-11-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cardiac rehabilitation is an important link in cardiovascular disease. This study mainly explores the effectiveness of new cardiac rehabilitation therapy (early respiratory rehabilitation, phase I rehabilitation, exercise therapy, external counterpulsation, extracorporeal shock wave, etc.) on patients with ischemic heart disease such as coronary heart disease and heart failure, and the compliance of home rehabilitation compared with traditional cardiac rehabilitation therapy (traditional exercise rehabilitation, rehabilitation education, etc.).

Detailed description: This study is a prospective, randomized, controlled study, follow the principle of PICOST design, specific as follows: Participants (the list) : preliminary clinical diagnosis of coronary atherosclerotic heart disease, heart failure. Intervention (Intervention) : conventional drug therapy + new cardiac rehabilitation therapy, a new cardiac rehabilitation treatment reference guide requirements, according to the actual circumstance of patients treated with 1-3 months Intervention. Comparator(control): conventional drug therapy + traditional cardiac rehabilitation therapy. The traditional cardiac rehabilitation therapy referred to domestic and international guidelines and consensus, and used 1 week-3 months of treatment intervention according to the actual situation of patients. Outcome (the end) : the primary end point: D_SPECT examination, were followed up for 6 months to evaluate myocardial perfusion imaging is reduce ischemic area. The secondary end point: 1) the blood biochemical examination and myocardial necrosis markers, etc.; 2) the cardiopulmonary exercise testing: maximum kilograms oxygen uptake and anaerobic threshold when the maximum kilograms oxygen uptake; 3) the major adverse cardiovascular events: cardioascular death, non-fatal myocardial infarction, unplanned coronary artery reconstruction, stroke, heart failure and angina associated hospitalized again; 4) patients family rehabilitation treatment adherence

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 85 years old
* Female subjects no pregnancy
* The main admission diagnosis of ischemic heart disease (coronary heart disease, myocardial infarction, ischemic heart failure, etc.)
* The need for cardiac rehabilitation treatment

Exclusion Criteria:

* acute respiratory distress syndrome (ARDS);
* acute episode of COPD;
* uncontrolled pulmonary infection;
* acute heart failure; acute pulmonary embolism;
* acute myocarditis/pericarditis;
* severe arrhythmia (degree II or III atrioventricular block, atrial flutter, or atrial fibrillation);
* sternotomy, rib fracture, thoracic deformity, or other neurological diseases that may affect respiratory muscles

Primary outcomes:
measure: Change from baseline myocardial infarct area at 6 months
timeFrame: 1 day of inclusions and 6 months after the first treatment.
Secondary outcomes:
measure: 6 months hemodynamic changes in relative to the baseline
timeFrame: 1 day of inclusions and 6 months after the first treatment.
measure: Change from baseline peak oxygen consumption at 6 months
timeFrame: 1 day of inclusions and 6 months after the first treatment.
Other outcomes:
measure: Major adverse cardiovascular events (MACE）
timeFrame: From the date of inclusion until the date of documented adverse events with 6 months
measure: Other treatment-related adverse reactions
timeFrame: From the date of inclusion until the date of treatment-related adverse reactions within 6 months
Locations:
city: Shanghai
country: China
facility: Department of Cardiology, Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
References: