Clinical trial NCT03297164: Incidence Rate of Heart Failure After Acute Myocardial Infarction With Optimal Treatment
Official title: One Year Incidence Rate of Heart Failure After Acute Myocardial Infarction With Optimal Treatment-A Prospective,Multicenter,Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Heart Failure
Keywords: acute myocardial infarction
heart failure
optimized treatment
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 12043
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: acute myocadial infarction

Brief summary: 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%.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: incidence rate of heart failure
timeFrame: 12th month after diacharge
Secondary outcomes:
measure: MACCE rate
timeFrame: 12th month after diacharge
measure: bleeding rate
timeFrame: 12th month after diacharge
measure: severe adverse drug reactions
timeFrame: 12th month after diacharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing An Zhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking Univerisity People'Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong general hospital
state: Guangdong
city: Nanning
country: China
facility: The first affiliated hospital of Guangxi medical university
state: Guangxi
city: Shijiazhuang
country: China
facility: Second hospital of hebei medical university
state: Hebei
city: Daqing
country: China
facility: Daqing Oilfield General Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: The first affiliated hospital of Zhengzhou medical university
state: Henan
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: the second affiliated hospital of Dalian medical university
state: Liaoning
city: Shenyang
country: China
facility: Shenyang military district general hospital of the people's liberation army
state: Liaoning
city: Xi'an
country: China
facility: The first affiliated hospital of military medical university
state: Shanxi
city: Chongqing
country: China
facility: Third Military Medical University
state: Sichuan
city: Tianjing
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Tianjin
country: China
facility: The General Hospital of Tianjin Medical University
state: Tianjin
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
References:
citation: 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.