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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03158597
Other study ID # 5172011
Secondary ID
Status Recruiting
Phase N/A
First received May 15, 2017
Last updated July 12, 2017
Start date June 1, 2017
Est. completion date December 31, 2019

Study information

Verified date July 2017
Source Beijing Institute of Heart, Lung and Blood Vessel Diseases
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- AMI patients:

1. 20-50 years of age

2. Symptoms of ischaemia

3. New significant ST-segment-T wave changes in ECG and definitive diagnosis of non-ST elevation MI or ST elevation MI

4. Cardiac troponin with at least one value above the 99th percentile upper reference limit

- Normal control participants:

1. 20-50 years of age

2. Normal ECG

3. BMI <24kg/m2

4. systolic blood pressure <140mmHg

5. diastolic blood pressure <90mmHg

6. Total cholesterol <200mg/dl (5.18mmol/L)

7. Triglyceride <150mg/dl (1.70mmol/L)

8. High density lipoprotein cholesterol >=40mg/dl (1.04mmol/L)

9. Low density lipoprotein cholesterol <130mg/dl (3.37mmol/L)

10. Fasting blood glucose <100mg/dl (5.6mmol/L)

11. Not taking antihypertensive or hypolipidemic or hypoglycemic drugs

Exclusion Criteria:

1. 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

2. Prior myocardial infarction

3. Percutaneous coronary intervention related MI

4. Stent thrombosis associated with MI

5. Coronary artery bypass grafting related MI

6. Recurrent MI or reinfarction

7. Myocardial injury with necrosis caused by transcatheter aortic valve implantation or mitral clip or ablation of arrhythmias

8. Myocardial injury or infarction associated with heart failure

9. Myocardial infarction in the intensive care unit

10. Other diseases: previous history of ASCVD, cancer, rheumatoid arthritis, liver or kidney disease, myeloproliferative disorders, chronic inflammation, peripheral vascular disease

11. Not available informed consent

Study Design


Locations

Country Name City State
China Beijing Anzhen Hospital Beijing Chaoyang

Sponsors (1)

Lead Sponsor Collaborator
Beijing Institute of Heart, Lung and Blood Vessel Diseases

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of screening differentially expressed genes associated with acute myocardial infarction as measured by microarray up to 3 years
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