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

November 7, 2024 updated by: Ya-Wei Xu, Shanghai 10th People's Hospital

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

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.).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Recruiting
        • Department of Cardiology, Shanghai Tenth People's Hospital
        • Contact:
        • Contact:
          • Yawei Xu, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The new rehabilitation group
Routine 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.
Device: Metronomic breathing, exercise rehabilitation, external counterpulsation, extracorporeal shock wave.
Phase I rehabilitation(Metronomic breathing，exercise rehabilitation）,Phase II rehabilitation (exercise rehabilitation, external counterpulsation, extracorporeal shock) wave.)
Active Comparator: The traditional rehabilitation group.
Routine drug therapy + traditional cardiac rehabilitation therapy, traditional cardiac rehabilitation treatment for reference domestic and international guidelines and consensus, according to the actual circumstance of patients treated with 1-3 months intervention.
Device: bedside rehabilitation and breathing, balance, flexibility, movement rehabilitation
Phase I rehabilitation (bedside rehabilitation, breathing rehabilitation), Phase II rehabilitation (breathing, balance, flexibility, movement)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day of inclusions and 6 months after the first treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day of inclusions and 6 months after the first treatment.
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)
1 day of inclusions and 6 months after the first treatment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other treatment-related adverse reactions
Time Frame: From the date of inclusion until the date of treatment-related adverse reactions within 6 months
From the date of inclusion until the date of treatment-related adverse reactions within 6 months
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
From the date of inclusion until the date of documented adverse events with 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Collaborators

Science and Technology Commission of Shanghai Municipality

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

November 3, 2024

First Submitted That Met QC Criteria

November 7, 2024

First Posted (Estimated)

November 8, 2024

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 7, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rehabilitation-ICM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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