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CompletedNCT04950699PUUMAUpdated Jul 6, 2021

Peking University & University of Michigan Study of MI and Atherosclerosis

An observational study in Coronary Heart Disease, sponsored by Peking University Third Hospital. Completed. Per ClinicalTrials.gov, last updated 2021-07-06.

Sponsored by Peking University Third Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
4,700
Sex
All
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Study summary

Coronary heart disease and myocardial infarction have become a major threat to the health of our people. Their incidence rate and mortality rate are still rising. Dyslipidemia is one of the important risk factors. However, little is known about the genetic information of myocardial infarction and dyslipidemia, especially in Chinese population. This project aims to identify new loci related to myocardial infarction and blood lipid level in Chinese population, compare these gene variations with 94 gene variations related to myocardial infarction and blood lipid level in European population, and extract gene variations related to myocardial infarction and blood lipid level in Chinese population. In this case-control study, 3998 blood samples and 702 new blood samples were collected from the sample bank of Peking University Third Hospital and first hospital, respectively. The blood samples were collected from Asian heart disease hospital, Taiyuan cardiovascular disease hospital, Beijing Third Hospital and Shijingshan community follow-up population According to the results of carotid ultrasound or treadmill exercise test, the samples were divided into myocardial infarction group and control group, and the corresponding blood lipid levels were collected. The samples were genotyped by the metabochip gene chip of Illumina company. The data were processed by the calling algorithm of BeadStudio Gentrain 1.0 and the GenoSNP software. The related genes of myocardial infarction were analyzed by logistic regression, and the related genes of blood lipid level were analyzed by linear regression.

Read the detailed description

Background: coronary heart disease and myocardial infarction have become a major disease threatening the health of our people. Their incidence rate and mortality rate are still rising. Dyslipidemia is one of the important risk factors. However, little is known about the genetic information of myocardial infarction and dyslipidemia, especially in Chinese population.

Objective: to identify new loci related to myocardial infarction and blood lipid level in Chinese population, compare these gene variations with 94 gene variations related to myocardial infarction and blood lipid level in European population, and extract gene variations related to myocardial infarction and blood lipid level in Chinese population.

Methods: This is a case-control study. 9498 blood samples and 702 new blood samples were collected from the sample bank of Peking University Third Hospital and first hospital respectively. The blood samples were collected from Asian heart disease hospital, Beijing Third Hospital and Shijingshan community follow-up population According to the results of carotid ultrasound or treadmill exercise test, the samples were divided into myocardial infarction group and control group, and the corresponding blood lipid levels were collected. The samples were genotyped by the metabochip gene chip of Illumina company. The data were processed by the calling algorithm of BeadStudio Gentrain 1.0 and the GenoSNP software. The related genes of myocardial infarction were analyzed by logistic regression, and the related genes of blood lipid level were analyzed by linear regression.

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Conditions studied

  • Coronary Heart Disease

Keywords

  • Single-nucleotide Polymorphism
  • Dyslipidemia
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In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 4,700 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The samples of this study are from Peking University Third Hospital, Peking University First Hospital and Wuhan Asian Heart Hospital.

Inclusion criteria

  • Myocardial infarction group: case group

This group includes acute myocardial infarction (ST segment elevation and non ST segment elevation) and old myocardial infarction. The diagnostic basis of acute myocardial infarction: cardiac biomarkers (cardiac troponin and / or myocardial enzymes) increased or decreased, at least once the value exceeded the upper limit of normal, and there was the following evidence of myocardial ischemia: (1) clinical symptoms of myocardial ischemia( 2) New changes of myocardial ischemia appeared in ECG, i.e. new ST segment changes or left bundle branch block( 3) Pathological Q wave appeared in ECG( 4) Imaging evidence showed new loss of myocardial viability or regional wall motion abnormalities. Diagnosis basis of old myocardial infarction: Patients with previous history of myocardial infarction and confirmed by Peking University Third Hospital, first hospital, Asian heart hospital and Taiyuan cardiovascular hospital.

3.4.2 non coronary heart disease group: control group

The patients in the control group can be enrolled if they meet any of the following criteria: (1) if the patients have no typical symptoms of coronary heart disease, and there is no obvious stenosis on coronary angiography and / or coronary CT (the degree of stenosis in the main coronary artery is less than 30%)( 2) if the patient had no typical symptoms of coronary heart disease, and the risk factors of coronary heart disease (smoking, hypertension, diabetes, hyperlipidemia, family history of premature coronary heart disease) were not more than 2, no plaque and / or treadmill exercise test were negative for carotid artery ultrasound.

Exclusion criteria

Exclusion Criteria:

  • (1) There was severe hepatic and renal insufficiency (2) Cancer and malignant disease patients (3) Severe acute infection or metabolic disorder (4) Acute attack of chronic heart failure (5) Acute myocardial infarction without revascularization within 2 weeks (6) Secondary to obvious valvular heart disease, hypertrophic obstructive heart disease
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
4,700 participants (actual)
Patient registry
No

Groups and cohorts

  • Control

    Patients without typical symptoms of coronary heart disease, and coronary angiography or coronary CT showed no significant stenosis (coronary stenosis less than 30%), they were non coronary heart disease group, namely control group.

    Genetic: Single-nucleotide Polymorphism of genes related with Dyslipidemia

  • myocardial infarction

    This group includes acute myocardial infarction (ST segment elevation and non ST segment elevation) and old myocardial infarction. The diagnostic basis of acute myocardial infarction: cardiac biomarkers (cardiac troponin and / or myocardial enzymes) increased or decreased, at least once the value exceeded the upper limit of normal, and there was the following evidence of myocardial ischemia: (1) clinical symptoms of myocardial ischemia( 2) New changes of myocardial ischemia appeared in ECG, i.e. new ST segment changes or left bundle branch block( 3) Pathological Q wave appeared in ECG( 4) Imaging evidence showed new loss of myocardial viability or regional wall motion abnormalities. Diagnosis of old myocardial infarction: the patient provided a history of previous myocardial infarction and confirmed as old myocardial infarction by the third or First Hospital of Peking University.

    Genetic: Single-nucleotide Polymorphism of genes related with Dyslipidemia

Interventions

  • GeneticSingle-nucleotide Polymorphism of genes related with Dyslipidemia

    This study is an observational study to study the effect of different genotypes on the incidence of myocardial infarction

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What researchers measure

Primary outcomes

  1. myocardial infarction

    This study is a retrospective study, selected patients with myocardial infarction and control group as the research object, no other research endpoint was set

    Time frame: Retrospective analysis of cases in 6 years before the start of the study

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04950699
Lead sponsor
Peking University Third Hospital
Collaborators
Peking University First Hospital, Wuhan Asia Heart Hospital
Responsible party
Sponsor
First posted
Jul 6, 2021
Start date
Jan 1, 2012
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016
Last update
Jul 6, 2021

Study contacts

Wei Gao, Dr.
principal investigator · Peking University Third Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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