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

NCT03528382 | Completed

• 1 other identifier: 2016YFC1301105
• Study Type: interventional
• Target: 3,103
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• The incidence of heart failure in 1 year follow-up

  The incidence of heart failure after cardiac rehabilitate

  1 year

Study Arms (3)

period I group

EXPERIMENTAL

Behavioral: Cardiac rehabilitation quality improvement system

period II group

EXPERIMENTAL

Behavioral: Cardiac rehabilitation quality improvement system

period III group

EXPERIMENTAL

Behavioral: Cardiac rehabilitation quality improvement system

Interventions

Cardiac rehabilitation quality improvement system BEHAVIORAL

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

period I group; period II group; period III group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yu Bo: lead

Study Sites (1)

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China

Location

Related Publications (1)

• Zheng X, Zhang M, Zheng Y, Zhang Y, Wang J, Zhang P, Yang X, Li S, Ding R, Siqin G, Hou X, Chen L, Zhang M, Sun Y, Wu J, Yu B. Quality indicators for cardiac rehabilitation after myocardial infarction in China: a consensus panel and practice test. BMJ Open. 2020 Dec 30;10(12):e039757. doi: 10.1136/bmjopen-2020-039757.

  PMID: 33380480 DERIVED

Study Officials

• Bo Yu, MD,PhD

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 17, 2018
• Study Start: July 1, 2018
• Primary Completion: June 30, 2021
• Study Completion: September 29, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-11

Locations

CN (1)