NCT03158597

Brief Summary

This study aims to compare whole-blood microarray gene-expression profiling between patients with acute myocardial infarction and normal participants without cardiovascular diseases. Firstly, screening differentially genes of mRNA to perform gene ontology and pathway analysis. Secondly, predicting target genes regulated by microRNA and constructing coexpression network with mRNA. Thirdly, biological function experiment of microRNA. Finally, revealing pathogenic mechanisms associated with acute myocardial infarction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2017

Typical duration 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

First Submitted

Initial submission to the registry

May 15, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

2.6 years

First QC Date

May 15, 2017

Last Update Submit

July 12, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of screening differentially expressed genes associated with acute myocardial infarction as measured by microarray

    up to 3 years

Study Arms (2)

AMI

Control

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

AMI patients will be selected from Emergency Department of Beijing An Zhen Hospital or Beijing Tong Ren Hospital. Normal control participants will be recruited from Health Examination Center of Beijing An Zhen Hospital.

You may qualify if:

  • AMI patients:
  • years of age
  • Symptoms of ischaemia
  • New significant ST-segment-T wave changes in ECG and definitive diagnosis of non-ST elevation MI or ST elevation MI
  • Cardiac troponin with at least one value above the 99th percentile upper reference limit
  • Normal control participants:
  • years of age
  • Normal ECG
  • BMI \<24kg/m2
  • systolic blood pressure \<140mmHg
  • diastolic blood pressure \<90mmHg
  • Total cholesterol \<200mg/dl (5.18mmol/L)
  • Triglyceride \<150mg/dl (1.70mmol/L)
  • High density lipoprotein cholesterol \>=40mg/dl (1.04mmol/L)
  • Low density lipoprotein cholesterol \<130mg/dl (3.37mmol/L)
  • +2 more criteria

You may not qualify if:

  • Cardiac death with symptoms suggestive of myocardial ischaemia and presumed new ischaemic ECG changes, but death occurred before cardiac biomarkers were obtained, or before cardiac biomarker values would be increased
  • Prior myocardial infarction
  • Percutaneous coronary intervention related MI
  • Stent thrombosis associated with MI
  • Coronary artery bypass grafting related MI
  • Recurrent MI or reinfarction
  • Myocardial injury with necrosis caused by transcatheter aortic valve implantation or mitral clip or ablation of arrhythmias
  • Myocardial injury or infarction associated with heart failure
  • Myocardial infarction in the intensive care unit
  • Other diseases: previous history of ASCVD, cancer, rheumatoid arthritis, liver or kidney disease, myeloproliferative disorders, chronic inflammation, peripheral vascular disease
  • Not available informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Chaoyang, 100029, China

RECRUITING

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 18, 2017

Study Start

June 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

July 14, 2017

Record last verified: 2017-07

Locations