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

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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

Tracking Information
First Submitted Date December 14, 2015
First Posted Date December 29, 2015
Last Update Posted Date February 17, 2016
Study Start Date December 2015
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 28, 2015)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 28, 2015)
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Novel Risk Factors and Clinical Outcomes of Acute Myocardial Infarction
Official Title A Multicenter Prospective Observational Study to Evaluate the Novel Risk Factors and Clinical Outcomes of Acute Myocardial Infarction (AMI)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood specimens for biomarker analysis and storage for future genetic studies
Sampling Method Non-Probability Sample
Study Population Patients presenting to an emergency room and diagnosed as acute myocardial infarction
Condition
  • Coronary Artery Disease
  • Percutaneous Coronary Intervention
  • Acute Myocardial Infarction
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 28, 2015)
3000
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02641184
Other Study ID Numbers ZJPPH01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: No plan to share data
Responsible Party Xiao Ye, MD, Zhejiang Provincial People’s Hospital
Study Sponsor Zhejiang Provincial People’s Hospital
Collaborators
  • Yangzhou No.1 People's Hospital
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • Huaian first people's hospital
Investigators
Principal Investigator: Baiming Qu, MD Department of Cardiology, Zhejiang Provincial People's Hospital
PRS Account Zhejiang Provincial People’s Hospital
Verification Date February 2016