Incidence Rate of Heart Failure After Acute Myocardial Infarction With Optimal Treatment

One Year Incidence Rate of Heart Failure After Acute Myocardial Infarction With Optimal Treatment-A Prospective,Multicenter,Cohort Study

The main purpose of this study is to build a multi-center, prospective and regionally representative acute myocardial infarction(AMI) cohort，and build a study platform for heart failure caused by AMI; To explore the 1 year incidence rate of heart failure after AMI given the optimized treatment and the treatment model affecting the incidence rate of heart failure, and finally to reduce the incidence rate of heart failure by 5%.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Acute Myocardial Infarction

Detailed Description

the study aim to enroll 12000 acute myocardial infartion (AMI) patients, including ST-segment elevation myocardial infarction (STEMI) and non ST-segment elevation myocardial infarction (NSETMI), Patients were divided into two groups(optimized group and un-optimized group) according to treatment models they accepted in 20 reginally representative hosptials of China. whether optimizaed or not is judged by 4 four aspects,including emergency treatment procedure, pre-infusion medication, reperfusion strategy selection, and early rehabilitation after reperfusion.Patients were followed at 1 month, 6 months and 12 months. The physical condition and clinical events(heart failure, death, re-infarction, revascularization, apoplexy, malignant arrhythmias, bleeding events, other adverse events)were collected at follow up.

• Study Type: Observational
• Enrollment (Actual): 12043

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking University First Hospital
    • Beijing, Beijing, China, 100044
      • Peking Univerisity People'Hospital
    • Beijing, Beijing, China
      • Beijing Chao-Yang Hospital, Capital Medical University
    • Beijing, Beijing, China, 100029
      • Beijing An Zhen Hospital, Capital Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangdong General Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The First Affiliated Hospital of Guangxi Medical University
  • Hebei
    • Shijiazhuang, Hebei, China
      • Second Hospital of Hebei Medical University
  • Heilongjiang
    • Daqing, Heilongjiang, China, 163001
      • Daqing Oilfield General Hospital
  • Henan
    • Zhengzhou, Henan, China
      • The first affiliated hospital of Zhengzhou medical university
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The Second Affiliated Hospital of Nanchang University
  • Jilin
    • Changchun, Jilin, China, 130000
      • The Second Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China
      • The Second Affiliated Hospital of Dalian Medical University
    • Shenyang, Liaoning, China
      • Shenyang military district general hospital of the people's liberation army
  • Shanxi
    • Xi'an, Shanxi, China
      • The first affiliated hospital of military medical university
  • Sichuan
    • Chongqing, Sichuan, China
      • Third Military Medical University
  • Tianjin
    • Tianjin, Tianjin, China
      • The General Hospital of Tianjin Medical University
    • Tianjing, Tianjin, China
      • Tianjin Chest Hospital
  • Xinjiang
    • Urumqi, Xinjiang, China
      • The First Affiliated Hospital of Xinjiang Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

acute myocadial infarction

Description

Inclusion Criteria:

• age≥18 years
• diagnosed acute myocardial infarction
• signed the informed consent form

Exclusion Criteria:

• AMI is caused by surgery, trauma, gastrointestinal bleeding or complications of PCI;
• AMI occurred in patients who have been hospitalized for other reasons;
• patients with previous history of chronic heart failure;
• researchers judging that patient's compliance was poor and could not complete the study according to the requirements.
• life expectancy is less than 12 months;
• heart transplant patients;
• patients with tumors;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
optimized group; the patients in this group have been given the suggestive treatment from guideline.
un-optimized group; the patients in this group have not been given the suggestive treatment from guideline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence rate of heart failure	incidence rate of heart failure of acute myocardial infarction at 12th month	12th month after diacharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCE rate	the major adverse cardiac celebral events including death,reinfarction,	12th month after diacharge
bleeding rate	the incidence rate of bleeding	12th month after diacharge
severe adverse drug reactions	severe adverse drug reactions at 12th month	12th month after diacharge

Collaborators and Investigators

• Sponsor: Harbin Medical University

Publications and helpful links

General Publications

• Li L, Zhang X, Wang Y, Yu X, Jia H, Hou J, Li C, Zhang W, Yang W, Liu B, Lu L, Tan N, Yu B, Li K. A Novel Risk Score to Predict In-Hospital Mortality in Patients With Acute Myocardial Infarction: Results From a Prospective Observational Cohort. Front Cardiovasc Med. 2022 Apr 7;9:840485. doi: 10.3389/fcvm.2022.840485. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 21, 2017
• Primary Completion (ACTUAL): December 4, 2020
• Study Completion (ACTUAL): June 30, 2021

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (ACTUAL): September 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: heart failure; acute myocardial infarction; optimized treatment
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Heart Failure
• Other Study ID Numbers: 2016YFC1301101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No