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

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ClinicalTrials.gov Identifier: NCT03297164
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Yu Bo, Harbin Medical University

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%.

Condition or disease
Acute Myocardial Infarction Heart Failure

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
Estimated Enrollment : 12000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: One Year Incidence Rate of Heart Failure After Acute Myocardial Infarction With Optimal Treatment-A Prospective,Multicenter,Cohort Study
Actual Study Start Date : December 21, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. incidence rate of heart failure [ Time Frame: 12th month after diacharge ]
    incidence rate of heart failure of acute myocardial infarction at 12th month


Secondary Outcome Measures :
  1. MACCE rate [ Time Frame: 12th month after diacharge ]
    the major adverse cardiac celebral events including death,reinfarction,

  2. bleeding rate [ Time Frame: 12th month after diacharge ]
    the incidence rate of bleeding

  3. severe adverse drug reactions [ Time Frame: 12th month after diacharge ]
    severe adverse drug reactions at 12th month



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
acute myocadial infarction
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297164


Contacts
Contact: Bo Yu, MD,PhD +86-0451-86605800 yubodr@163.com
Contact: Haibo Jia, MD,PhD +86-0451-86605359 jhb101180@163.com

Locations
China, Beijing
Beijing An Zhen Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China, 100029
Contact: Chunmei Wang       wangchunmei0214@sina.com   
Peking Univerisity People'Hospital Not yet recruiting
Beijing, Beijing, China, 100044
Contact: Weimin Wang       weiminwang@vip.sina.com   
Beijing Chao-Yang Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China
Contact: Lefeng Wang       wlf311@sohu.com   
Peking University First Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Jianping Li       lijianping@medmail.com.cn   
China, Guangdong
Guangdong general hospital Not yet recruiting
Guangzhou, Guangdong, China
Contact: Ning Tan       tanning100@126.com   
China, Guangxi
The first affiliated hospital of Guangxi medical university Not yet recruiting
Nanning, Guangxi, China, 530021
Contact: Lang Li       drlilang@163.com   
China, Hebei
Second hospital of hebei medical university Recruiting
Shijiazhuang, Hebei, China
Contact: Xinshun Gu       348220248@qq.com   
China, Heilongjiang
Daqing Oilfield General Hospital Not yet recruiting
Daqing, Heilongjiang, China, 163001
Contact: Hui Li       huilee_2006@163.com   
China, Henan
The first affiliated hospital of Zhengzhou medical university Not yet recruiting
Zhengzhou, Henan, China
Contact: Ling Li       liling63035@sina.com   
China, Jiangsu
Zhongda Hospital Southeast University Not yet recruiting
Nanjing, Jiangsu, China, 210009
Contact: Genshan Ma       magenshan@hotmail.com   
China, Jiangxi
The Second Affiliated Hospital of Nanchang University Not yet recruiting
Nanchang, Jiangxi, China, 330006
Contact: Yanqing Wu       wuyanqing01@sina.com   
China, Jilin
The Second Hospital of Jilin University Not yet recruiting
Changchun, Jilin, China, 130000
Contact: Bin Liu       liubin3333@vip.sina.com   
China, Liaoning
the second affiliated hospital of Dalian medical university Not yet recruiting
Dalian, Liaoning, China
Contact: Peng Qu       qupeng777@aliyun.com   
Shenyang military district general hospital of the people's liberation army Not yet recruiting
Shenyang, Liaoning, China
Contact: Bin Wang       wangbindl@hotmail.com   
China, Shanxi
The first affiliated hospital of military medical university Not yet recruiting
Xi'an, Shanxi, China
Contact: Zhijing Zhao       zhaozhj@fmmu.edu.cn   
China, Sichuan
Third Military Medical University Not yet recruiting
Chongqing, Sichuan, China
Contact: Jun Jin       jjxqyy@163.com   
China, Tianjin
Tianjin Chest Hospital Not yet recruiting
Tianjing, Tianjin, China
Contact: Chunjie Li       ykwn@sina.com   
The General Hospital of Tianjin Medical University Not yet recruiting
Tianjin, Tianjin, China
Contact: Wenjuan Zhang       zwjzyy2013@163.com   
China, Xinjiang
The First Affiliated Hospital of Xinjiang Medical University Not yet recruiting
Urumqi, Xinjiang, China
Contact: Yining Yang       yangyn5126@163.com   
Sponsors and Collaborators
Harbin Medical University

Responsible Party: Yu Bo, director, Harbin Medical University
ClinicalTrials.gov Identifier: NCT03297164     History of Changes
Other Study ID Numbers: 2016YFC1301101
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yu Bo, Harbin Medical University:
acute myocardial infarction
heart failure
optimized treatment

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases