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NCT Number: NCT06681506

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

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.).

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location status: Recruiting

Location contact

Weijing Liu, PhD

CONTACT

[email protected]

+86 189 1768 4041

Yawei Xu, MD, PhD

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metronomic breathing, exercise rehabilitation, external counterpulsation, extracorporeal shock wave.

Device

Phase I rehabilitation(Metronomic breathing,exercise rehabilitation),Phase II rehabilitation (exercise rehabilitation, external counterpulsation, extracorporeal shock) wave.)

bedside rehabilitation and breathing, balance, flexibility, movement rehabilitation

Device

Phase I rehabilitation (bedside rehabilitation, breathing rehabilitation), Phase II rehabilitation (breathing, balance, flexibility, movement)

Primary outcomes

  1. Change from baseline myocardial infarct area at 6 months

    Time frame: 1 day of inclusions and 6 months after the first treatment.

    The location and extent of myocardial infarction were determined by D-SPECT.

Secondary outcomes

  1. 6 months hemodynamic changes in relative to the baseline

    Time frame: 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.

  2. Change from baseline peak oxygen consumption at 6 months

    Time frame: 1 day of inclusions and 6 months after the first treatment.

    maximum oxygen and maximum kilogram oxygen uptake accessed during Cardiopulmonary Exercise Testing (CPET)

Other outcomes

  1. Major adverse cardiovascular events (MACE)

    Time frame: From the date of inclusion until the date of documented adverse events with 6 months

    cardiovascular death, non-fatal myocardial infarction, unplanned coronary revascularization, stroke, heart failure, and angina-related rehospitalization

  2. Other treatment-related adverse reactions

    Time frame: From the date of inclusion until the date of treatment-related adverse reactions within 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

liujing liu, MD, PhD

CONTACT

[email protected]

+86 18917684041

zhaoxin zhu, B.D

CONTACT

[email protected]

+86 13162999337

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Collaborators

  • Shanghai Municipal Science and Technology Commission

Registry information

Official study title

A New Cardiac Rehabilitation Treatment in the Application of Ischemic Heart Disease: a Prospective, Randomized Controlled Clinical Study

Important dates

Study start
2024
Primary completion
2028
Study completion
2031
First posted
Nov 8, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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