Acute Myocardial InfarctionNCT03158597
Transcriptome Study of Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- Healthy volunteers accepted
- 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.
Who may be able to join
- AMI patients:
- 20-50 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:
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- 20-50 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)
- Fasting blood glucose <100mg/dl (5.6mmol/L)
- Not taking antihypertensive or hypolipidemic or hypoglycemic drugs
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Chaoyang, 100029
Yan Li, 861064456736, torrancely@sina.com
About this study
Official title: Screening Pathogenic Genes Associated With Acute Myocardial Infarction and Studying Its Relevant Molecular Mechanism
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.
- Conditions
- Acute Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AMI | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of screening differentially expressed genes associated with acute myocardial infarction as measured by microarray
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start1 Jun 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Li, Beijing Institute of Heart, Lung and Blood Vessel Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158597
- Sponsor's protocol ID
- 5172011
- Status last verified
- Jul 2017
- First submitted
- 15 May 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Pathogenic Genes Associated With Acute Myocardial Infarction and Studying Its Relevant Molecular Mechanism
- ClinicalTrials.gov ID
- NCT03158597
- Acronym / sponsor ID
- 5172011
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel DiseasesUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMI | – | – |
| Control | – | – |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (17 listed)
- AMI patients:
- Normal control participants:
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of screening differentially expressed genes associated with acute myocardial infarction as measured by microarray
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of screening differentially expressed genes associated with acute myocardial infarction as measured by microarray (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2017.