Multi-omics Study of Clinical Endpoints in CHD
OmiDETCHD
Multi-omics Study of the Individual Differences of Drug Efficacy and Toxicity in Patients With Coronary Heart Disease
1 other identifier
observational
4,000
1 country
5
Brief Summary
This study aimed to explore underlying mechanisms of individual differences in drugs for coronary heart disease treatment and its association with adverse consequences. It will enroll approximately 4000 coronal heart disease patients aged between 18 and 80 years in mainland China and follow-up for at least 1 years. Questionnaires, anthropometric measures, laboratory tests, and biomaterials will be collected . The principal clinical outcomes of the study consist of ischemia attack , cardiac death, renal injury,and myotoxic activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 5, 2019
CompletedFirst Posted
Study publicly available on registry
January 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFebruary 12, 2019
February 1, 2019
2.5 years
January 5, 2019
February 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death
All-cause death
from date of baseline examination until the date of first documented death,up to 48 months
Secondary Outcomes (4)
MACE
from date of baseline examination until the date of first documented cardiovascular events,up to 48 months
Bleeding
from date of baseline examination until the date of first documented bleeding,up to 48 months
Statin-induced myopathy (SIM)
from date of baseline examination until the date of first documented SIM,up to 48 months
CI-AKI
more than 6 h within 48 h after Coronary Angiography
Other Outcomes (1)
SYNTAX score
more than 6 h within 48 h after Coronary Angiography
Study Arms (2)
Discovery cohort
1000 cases of coronary heart disease follow-up cohort was used for multi-omics target discovery.During the follow-up period, the information about the occurrence and risk factors of adverse cardiovascular events will be collected.
Validation corhort
3000 coronary heart disease follow-up cohorts was used for validating the results from the discovery corhort. During the follow-up period, the occurrence and risk factors of adverse cardiovascular events.Predictive mathematical models based on multi-omics combination will be constructed finally.
Interventions
During the follow-up period,general information(age, sex, BMI, blood pressure, the history of drink and smoke, medical history, etc).Blood biochemistry parameters（Lipid, hsCRP levels, etc）and other laboratory examination parameters will be collected
Genome-wide genotype , DNA methylation and metabolomes were determined using illumina high-density genotyping chips, high-throughput sequencing, and high-resolution mass spectrometry respectly. Blood exposure of statins and metoprolol and its metabolites was determined by UPLC-MS/MS.
The genome-wide genotype of patients with coronary heart disease was detected using the illumina chip. The methylation level of the functional region was detected by the target region enrichment methylation sequencing method. Intestinal flora differences were detected using 16SrDNA high-throughput sequencing.
Machine learning algorithms such as multiple linear regression or Bayesian classification are used to optimize clinical factors and multi-group targets to establish predictive mathematical models.
Eligibility Criteria
Chinese Han patients with coronary artery disease who have ingested metoprolol and statins were prospectively recruited from Guangdong General Hospital, Shanghai Jiao Tong University, Central South University, Sun Yat-sen University and Sichuan University.
You may qualify if:
- age: 18-80 years
- Chinese Han patients with coronary artery disease
- inpatients undergoing coronary angiography or percutaneous coronary intervention
You may not qualify if:
- renal insufficiency (defined as serum creatinine concentration \> 2 times the upper limit of normal \[230 μmol/L\], renal transplantation or dialysis)
- hepatic insufficiency (defined as serum transaminase concentration \> 2 times the upper limit of normal \[80 U/L\], or a diagnosis of cirrhosis)
- pre-existing bleeding disorders
- being pregnant or lactating
- advanced cancer or haemodialysis
- history of thyroid problems, and use of antithyroid drugs or thyroid hormone medication
- incomplete information about cardiovascular events during follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guangdong Provincial People's Hospitallead
- RenJi Hospitalcollaborator
- West China Hospitalcollaborator
- Xiangya Hospital of Central South Universitycollaborator
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
Study Sites (5)
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
XiangYa Hospital Central South University
Changsha, Hunan, 410008, China
Renji Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200233, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Related Publications (1)
Chen Y, Jiang H, Zhan Z, Lu J, Gu T, Yu P, Liang W, Zhang X, Liu S, Bi H, Zhong S, Tang L. Restoration of lipid homeostasis between TG and PE by the LXRalpha-ATGL/EPT1 axis ameliorates hepatosteatosis. Cell Death Dis. 2023 Feb 6;14(2):85. doi: 10.1038/s41419-023-05613-6.
PMID: 36746922DERIVED
Biospecimen
Feces,urine,and blood are from patients with coronary heart disease.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shilong Zhong, Ph.D
Guangdong Provincial People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 5, 2019
First Posted
January 9, 2019
Study Start
July 1, 2017
Primary Completion
December 31, 2019
Study Completion
December 31, 2020
Last Updated
February 12, 2019
Record last verified: 2019-02