NCT03528382

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

Completed NA Last updated 8 November 2021

What this trial tests

NA trial testing Cardiac rehabilitation quality improvement system in Acute Myocardial Infarction in 3,103 participants. Completed in 29 September 2021.

Timeline

1 July 2018

Primary endpoint
30 June 2021

29 September 2021

Quick facts

Lead sponsor	Yu Bo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	3,103
Start date	1 July 2018
Primary completion	30 June 2021
Estimated completion	29 September 2021
Sites	1 location across China

Drugs / interventions tested

• Cardiac rehabilitation quality improvement system

Conditions studied

• Acute Myocardial Infarction — all drugs for Acute Myocardial Infarction →

Sponsor

Yu Bo

Who can join

Adults 18 to 80, any sex, with Acute Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Quality indicators for cardiac rehabilitation after myocardial infarction in China: a consensus panel and practice test.
   Zheng X, Zhang M, Zheng Y, Zhang Y, et al · · 2020 · cited 4× · PMID 33380480 · DOI 10.1136/bmjopen-2020-039757