Peking University & University of Michigan Study of MI and Atherosclerosis

Coronary Heart Disease Clinical Trial

— PUUMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04950699
• Other study ID #: 2012092
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: December 31, 2016

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4700
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Genetic:
• Single-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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Peking University Third Hospital	Peking University First Hospital, Wuhan Asia Heart Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Retrospective analysis of cases in 6 years before the start of the study