NCT04950699

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2021

Completed
Last Updated

July 6, 2021

Status Verified

June 1, 2021

Enrollment Period

5 years

First QC Date

June 27, 2021

Last Update Submit

June 27, 2021

Conditions

Keywords

Single-nucleotide PolymorphismDyslipidemia

Outcome Measures

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

    Retrospective analysis of cases in 6 years before the start of the study

Study Arms (2)

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

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

Controlmyocardial infarction

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \- 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.
  • 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.

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary DiseaseDyslipidemias

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Wei Gao, Dr.

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 6, 2021

Study Start

January 1, 2012

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

July 6, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share