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Evaluation of Novel Risk Factors and Clinical Outcomes of Acute Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02641184
Recruitment Status : Unknown
Verified February 2016 by Xiao Ye, MD, Zhejiang Provincial People’s Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : December 29, 2015
Last Update Posted : February 17, 2016
Sponsor:
Collaborators:
Yangzhou No.1 People's Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Huaian first people's hospital
Information provided by (Responsible Party):
Xiao Ye, MD, Zhejiang Provincial People’s Hospital

Brief Summary:
The aim of this study is to investigate the potential novel risk factors for acute myocardial infarction. Predictors of poor outcomes will be also evaluated.

Condition or disease
Coronary Artery Disease Percutaneous Coronary Intervention Acute Myocardial Infarction

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Prospective Observational Study to Evaluate the Novel Risk Factors and Clinical Outcomes of Acute Myocardial Infarction (AMI)
Study Start Date : December 2015
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack




Primary Outcome Measures :
  1. Major adverse cardiovascular events (MACE) [ Time Frame: maximum 5 years ]
    Composite of angina pectoris, reinfarction, unplanned rehospitalization, stent thrombosis, incidence of cardiac death in the duration of follow-up


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: in the phase of hospital stay, maximum 30 days ]
    The length of in-hospital stay is counted as a secondary outcome

  2. New-onset diabetes [ Time Frame: the duration of follow-up, maximum 5 years ]
    New-onset diabetes are defined as newly-diagnosed type 2 diabetes mellitus


Biospecimen Retention:   Samples With DNA
Blood specimens for biomarker analysis and storage for future genetic studies


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
Patients presenting to an emergency room and diagnosed as acute myocardial infarction
Criteria

Inclusion Criteria:

  • Less than 12 hours after the onset of myocardial infarction symptoms
  • Myocardial necrosis, as evidenced by increased Creatine Kinase Isoenzyme (CK-MB) or troponin levels

Exclusion Criteria:

  • Age under 18 years-old

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): NCT02641184


Locations
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China, Zhejiang
Zhejiang provincial people's hospital
Hangzhou, Zhejiang, China, 310000
Sponsors and Collaborators
Zhejiang Provincial People’s Hospital
Yangzhou No.1 People's Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Huaian first people's hospital
Investigators
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Principal Investigator: Baiming Qu, MD Department of Cardiology, Zhejiang Provincial People's Hospital
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Responsible Party: Xiao Ye, MD, Doctor, Zhejiang Provincial People’s Hospital
ClinicalTrials.gov Identifier: NCT02641184    
Other Study ID Numbers: ZJPPH01
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data
Keywords provided by Xiao Ye, MD, Zhejiang Provincial People’s Hospital:
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Infarction
Diabetes
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases