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The Impact of Early Cardiac Rehabilitation of AMI Patients on the Incidence of Post-infarction HF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528382
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Yu Bo, Harbin Medical University

Brief Summary:

Background: Acute myocardial infarction (AMI) is the second cause of death worldwide. After AMI, the heart failure (HF) is a main cause of patient rehospitalization and death. Despite the total ischemic time of AMI is decreasing in general at present, the incidence of HF after AMI remains high. The incidence of HF in Switzerland and the United States are 25% and 14-16%, respectively, and the epidemiological statistic of AMI in the past 10 years was lacking in China, but the rate has been exceeded 22% by conservative estimation. Early cardiac rehabilitation quality improvement system has been shown to reduce incidence of post-infarction HF and improve cardiovascular function. However, early cardiac rehabilitation has low proportion and poor quality, which lacks of standard.

Objective: The purposes of this quality improvement study are to evaluate a pointed, two-phase intervention system to improve the proportion and quality of cardiac rehabilitation; to standardize the early cardiac rehabilitation procedure to improve the prognosis among patients with post-infarction HF.

Methods: Including the period I of cardiac rehabilitation, pre-discharge (baseline) assessment and the period II of cardiac rehabilitation.

Statistical analysis: Data analyses are performed using the software package SAS version 9.2 and all tests are 2-sided with P<0.05 denoting statistical significance. Quantitative data changes between groups which are compared with using the paired Student's t test and Wilcoxon rank sum test according to the data distribution, and categorical data is analyzed by chi-square test and ranked data is analyzed by Wilcoxon rank sum test. The investigator compare the incidence of heart failure in early rehabilitation patients between two phases according to the chi-square test of the rate of two groups, to explore the role of early cardiac rehabilitation after AMI in reducing the incidence of HF after AMI.


Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Behavioral: Cardiac rehabilitation quality improvement system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Impact of Early Cardiac Rehabilitation Quality Improvement System on the Incidence of Post-infarction HF: an Interventional Study
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : October 23, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: period I group Behavioral: Cardiac rehabilitation quality improvement system
Cardiac rehabilitation quality improvement system is divided into two period. The period I of rehabilitation has three parts, including daily life, rehabilitation exercise training, publicity and education. And the period II of rehabilitation is based on aerobic exercise, as well as combined with resistance and flexibility exercises

Experimental: period II group Behavioral: Cardiac rehabilitation quality improvement system
Cardiac rehabilitation quality improvement system is divided into two period. The period I of rehabilitation has three parts, including daily life, rehabilitation exercise training, publicity and education. And the period II of rehabilitation is based on aerobic exercise, as well as combined with resistance and flexibility exercises

Experimental: period III group Behavioral: Cardiac rehabilitation quality improvement system
Cardiac rehabilitation quality improvement system is divided into two period. The period I of rehabilitation has three parts, including daily life, rehabilitation exercise training, publicity and education. And the period II of rehabilitation is based on aerobic exercise, as well as combined with resistance and flexibility exercises




Primary Outcome Measures :
  1. The incidence of heart failure in 1 year follow-up [ Time Frame: 1 year ]
    The incidence of heart failure after cardiac rehabilitate



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients aged ≥18 and ≤80 years old with a diagnosis of AMI (include ST segment elevated myocardial infarction and non-ST segment elevated myocardial infarction)

Exclusion Criteria:

  • Pregnancy or lactation or with family planning during the trial;
  • A history of heart failure;
  • Severe liver dysfunction (The Alanine aminotransferase /aspartate aminotransferase level is over 3 times the upper normal limit);
  • End-stage renal disease or creatinine plasma levels > 2.0mg/Dl;
  • Tumor;
  • AMI is caused by surgery, trauma, gastrointestinal bleeding or other complications caused by percutaneous coronary intervention;
  • AMI occurred in patients who have been hospitalized for other reasons;
  • Heart allograft transplantation;
  • Participating in other clinical trials (except other subjects of this project) and have not reach the main end of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528382


Contacts
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Contact: Bo Yu, MD,PhD +86-0451-86605800 yubodr@163.com
Contact: Jian Wu, MD,PhD 15245001123 wujian780805@163.com

Locations
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China, Heilongjiang
The Second Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150086
Contact: Bo Yu, MD, PhD    +86-045186605180    yubodr@163.com   
Contact: Jian Wu, MD, PhD         
Sponsors and Collaborators
Yu Bo
Investigators
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Principal Investigator: Bo Yu, MD,PhD The Second Affiliated Hospital of Harbin Medical University
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Responsible Party: Yu Bo, Director, Harbin Medical University
ClinicalTrials.gov Identifier: NCT03528382    
Other Study ID Numbers: 2016YFC1301105
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases