Coronary Heart DiseasePUUMANCT04950699
Peking University & University of Michigan Study of MI and Atherosclerosis
An observational study of Coronary Heart Disease, run by Peking University Third Hospital.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Single-nucleotide Polymorphism of genes related with Dyslipidemia
- How many people
- 4,700 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Dec 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The samples of this study are from Peking University Third Hospital, Peking University First Hospital and Wuhan Asian Heart Hospital.
Who may be able to join
- 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.
Who cannot join
- (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
About this study
Official title: 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.
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.
- Conditions
- Coronary Heart Disease
- Being tested
- Single-nucleotide Polymorphism of genes related with Dyslipidemia
- Keywords
- Single-nucleotide Polymorphism, Dyslipidemia
- Medical subject headings
- Coronary Disease, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-nucleotide Polymorphism of genes related with DyslipidemiaGenetic
This study is an observational study to study the effect of different genotypes on the incidence of myocardial infarction
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Genetic: Single-nucleotide Polymorphism of genes related with Dyslipidemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Retrospective analysis of cases in 6 years before the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Jan 2012
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 4,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Wuhan Asia Heart Hospital
- Responsible party
- Sponsor
- Investigators
- Wei Gao, Dr., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950699
- Sponsor's protocol ID
- 2012092
- Acronym
- PUUMA
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peking University and University of Michigan- Study of Myocardial Infarction and Atherosclerosis
- ClinicalTrials.gov ID
- NCT04950699
- Acronym / sponsor ID
- PUUMA / 2012092
- Conditions
- Coronary Heart Disease
- Keywords
- Single-nucleotide Polymorphism, Dyslipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,700 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Wuhan Asia Heart Hospital
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 6 Jul 2021 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Genetic: Single-nucleotide Polymorphism of genes related with DyslipidemiaPatients 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. |
| myocardial infarction | – | Genetic: Single-nucleotide Polymorphism of genes related with DyslipidemiaThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The samples of this study are from Peking University Third Hospital, Peking University First Hospital and Wuhan Asian Heart Hospital.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-nucleotide Polymorphism of genes related with DyslipidemiaThis study is an observational study to study the effect of different genotypes on the incidence of myocardial infarction | Genetic | Control, myocardial infarction |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Wei Gao, Dr. principal investigator
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Peking University Third Hospital.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myocardial infarction (time frame: Retrospective analysis of cases in 6 years before the start of the study). 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 6 Jul 2021.