NCT02641184

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

December 14, 2015

Last Update Submit

February 13, 2016

Conditions

Coronary Artery DiseasePercutaneous Coronary InterventionAcute Myocardial Infarction

Keywords

Myocardial InfarctionCardiovascular DiseasesHeart DiseasesInfarctionDiabetes

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular events (MACE)

    Composite of angina pectoris, reinfarction, unplanned rehospitalization, stent thrombosis, incidence of cardiac death in the duration of follow-up

    maximum 5 years

Secondary Outcomes (2)

  • Length of hospital stay

    in the phase of hospital stay, maximum 30 days

  • New-onset diabetes

    the duration of follow-up, maximum 5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Age under 18 years-old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang provincial people's hospital

Hangzhou, Zhejiang, 310000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens for biomarker analysis and storage for future genetic studies

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial InfarctionCardiovascular DiseasesHeart DiseasesInfarctionDiabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular DiseasesIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Baiming Qu, MD

    Department of Cardiology, Zhejiang Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 14, 2015

First Posted

December 29, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2017

Last Updated

February 17, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

No plan to share data

Locations

CN(1)