Peking University & University of Michigan Study of MI and Atherosclerosis (PUUMA)

June 27, 2021 updated by: Peking University Third Hospital

Peking University and University of Michigan- Study of Myocardial Infarction and Atherosclerosis

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

4700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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:

  • (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
This study is an observational study to study the effect of different genotypes on the incidence of myocardial infarction
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.
This study is an observational study to study the effect of different genotypes on the incidence of myocardial infarction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
myocardial infarction
Time Frame: Retrospective analysis of cases in 6 years before the start of the study
This study is a retrospective study, selected patients with myocardial infarction and control group as the research object, no other research endpoint was set
Retrospective analysis of cases in 6 years before the start of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Wei Gao, Dr., Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2012

Primary Completion (ACTUAL)

December 31, 2016

Study Completion (ACTUAL)

December 31, 2016

Study Registration Dates

First Submitted

June 27, 2021

First Submitted That Met QC Criteria

June 27, 2021

First Posted (ACTUAL)

July 6, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 6, 2021

Last Update Submitted That Met QC Criteria

June 27, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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