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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03297164
• Other study ID #: 2016YFC1301101
• Status: Completed
• Start date: December 21, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2021
• Source: Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12043
• Est. completion date: June 30, 2021
• Est. primary completion date: December 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Heart Failure
• Infarction
• Myocardial Infarction

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence rate of heart failure	incidence rate of heart failure of acute myocardial infarction at 12th month	12th month after diacharge
Secondary	MACCE rate	the major adverse cardiac celebral events including death,reinfarction,	12th month after diacharge
Secondary	bleeding rate	the incidence rate of bleeding	12th month after diacharge
Secondary	severe adverse drug reactions	severe adverse drug reactions at 12th month	12th month after diacharge