A New Cardiac Rehabilitation Treatment in the Application of Ischemic Heart Disease

Not Applicable

Recruiting

• Conditions: Ischemic Heart Disease; Cardiac Rehabilitation

• Registration Number: NCT06681506
• Lead Sponsor: Shanghai 10th People's Hospital

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

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-03
• Study First Submitted QC: 2024-11-07
• Last Update Submitted: 2024-11-07
• Study First Posted: 2024-11-08
• Last Update Posted: 2024-11-08
• Primary Completion: 2028-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline myocardial infarct area at 6 months	1 day of inclusions and 6 months after the first treatment.	The location and extent of myocardial infarction were determined by D-SPECT.

Secondary Outcome Measures

Name	Time	Method
6 months hemodynamic changes in relative to the baseline	1 day of inclusions and 6 months after the first treatment.	Noninvasive hemodynamic evaluation of hemodynamic state, such as, the larger the value of Stroke volume, Stroke volume index, Cardiac output, Cardiac output index parameters, the smaller the value of Systemic vascular resistance, Systemic vascular resistance index parameters, the better the function of the patient's heart and arterial vessels.
Change from baseline peak oxygen consumption at 6 months	1 day of inclusions and 6 months after the first treatment.	maximum oxygen and maximum kilogram oxygen uptake accessed during Cardiopulmonary Exercise Testing (CPET)

Trial Locations

Locations (1)

Department of Cardiology, Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China