Transcriptome Study of Acute Myocardial Infarction | NCT03158597

Studies
Transcriptome Study of Acute Myocardial Infarction

NCT03158597

Sponsor

Beijing Institute of Heart, Lung and Blood Vessel Diseases

Status

Unknown status

Last Update Posted

Jul 14, 2017Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Acute Myocardial Infarction

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

May 15, 2017

First Submission Date that Met QC Criteria

May 17, 2017

First Posted Date

May 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2017

Last Update Posted Date

Jul 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Measure	Description	Time Frame
Number of screening differentially expressed genes associated with acute myocardial infarction as measured by microarray		up to 3 years

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Type	Date	Date Unknown
Release	Jan 21, 2020
Reset	Jan 29, 2020