Coronary Heart DiseaseOmiDETCHDNCT03797339
Multi-omics Study of Clinical Endpoints in CHD
An observational study of Coronary Heart Disease, run by Guangdong Provincial People's Hospital at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- risk factors of adverse cardiovascular events, multi-omics target discovery and validation
- How many people
- 4,000 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jul 2017to 31 Dec 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- age: 18-80 years
- Chinese Han patients with coronary artery disease
- inpatients undergoing coronary angiography or percutaneous coronary intervention
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
XiangYa Hospital Central South University
Changsha, Hunan, 410008
Qilin Ma, MD, 86731-84327203, mqilin2004@163.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Liang Ouyang, PhD, 8613880674611, ouyangliang@scu.edu.cn
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Shilong Zhong, Ph.D, 8618620819696, zhongsl@hotmail.com
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Chen Liu, MD, PhD, 8615013270269, chenliu81@hotmail.com
- Recruiting
Renji Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200233
Linghong Shen, MD, PhD, 8613916495713, drshenlinghong@126.com
About this study
Official title: Multi-omics Study of the Individual Differences of Drug Efficacy and Toxicity in Patients With Coronary Heart Disease
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.
Read the detailed description
The study is a multicenter prospective cohort study, aimed to explore underlying mechanisms of individual differences in drugs for coronary heart disease treatment and its association with adverse consequences.The genomic genotype, DNA methylation and metabolome of 1000 patients with coronary heart disease were determined using illumina high-density genotyping chip, high-throughput sequencing and high-resolution mass spectrometry. Blood exposures of statins and metoprolol and its metabolites was determined by UPLC-MS/MS.
The biological network using cross-omics analysis was reconstructed to identify potential causative key genes, bacteria, and endogenous metabolite targets that cause differences in individual responses. A machine identification algorithm selecting clinical factors and multi-omics targets was used to establish a predictive mathematical model.
A multi-center clinical cohort of 3000 coronal heart disease patients was used to verify the effects of various levels of omic targets on drug blood exposures, efficacy and toxic side effects. A comprehensive model based on multi-target combination of individualized drugs was constructed, and the predictive effect was clinically analyzed.
- Conditions
- Coronary Heart Disease
- Being tested
- risk factors of adverse cardiovascular events, multi-omics target discovery, validation, Predictive mathematical models
- Keywords
- epigenome, metabolome, microbiome, genome, multi-omics targets, individual drug use
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risk factors of adverse cardiovascular eventsOther
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
multi-omics target discoveryOther
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.
validationOther
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.
Predictive mathematical modelsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: risk factors of adverse cardiovascular events; Other: multi-omics target discovery | |
| 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. Receives: Other: risk factors of adverse cardiovascular events; Other: validation; Other: Predictive mathematical models |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
All-cause death
Measured: from date of baseline examination until the date of first documented death,up to 48 months
Secondary outcomes (4)
MACE
MACE was defined as the occurrence of cardiac death, nonfatal myocardial infarctions, coronary revascularisation and cerebral infraction.
Measured: from date of baseline examination until the date of first documented cardiovascular events,up to 48 months
Bleeding
Bleeding was the six-month incidence of combined alarming, internal, and nuisance bleeding events defined according to Serebruany et al15. Alarming bleeding included bleeding requiring a transfusion, intracranial bleeding, and life-threatening bleeding. Internal bleeding included haematoma, epistaxis, blood loss from the mouth, vagina, melaena, eye bleed, haematuria, and haematemesis. Nuisance bleeding included easy bruising, bleeding from small cuts, petechiae, and ecchymosis.
Measured: from date of baseline examination until the date of first documented bleeding,up to 48 months
Statin-induced myopathy (SIM)
The definition of SIM from statin treatment was based on the patients' subjective sense of muscular pain as well as CK elevations. These muscular side effects included myalgia (muscle pain/ache without serum CK elevations), other muscle-related symptoms such as weakness, cramps, spasms, soreness and twitching, CK elevations without physical symptoms, myositis or other muscle symptoms with CK elevations, and rhabdomyolysis.
Measured: from date of baseline examination until the date of first documented SIM,up to 48 months
CI-AKI
CI-AKI was diagnosed if a patient had an absolute increase in serum creatinine (sCr) concentration ≥ 0.3 mg/dl (26.4 μmol/L) from baseline or a relative increase ≥ 50 % in sCr concentration for more than 6 h within 48 h after surgery
Measured: more than 6 h within 48 h after Coronary Angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start1 Jul 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, West China Hospital, Xiangya Hospital of Central South University, First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Principal investigator, ShiLong Zhong, Guangdong Provincial People's Hospital
- Investigators
- Shilong Zhong, Ph.D, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797339
- Sponsor's protocol ID
- 2017YFC0909301
- Acronym
- OmiDETCHD
- Status last verified
- Feb 2019
- First submitted
- 5 Jan 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36746922
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omics Study of the Individual Differences of Drug Efficacy and Toxicity in Patients With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT03797339
- Acronym / sponsor ID
- OmiDETCHD / 2017YFC0909301
- Conditions
- Coronary Heart Disease
- Keywords
- epigenome, metabolome, microbiome, genome, multi-omics targets, individual drug use
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- RenJi Hospital, West China Hospital, Xiangya Hospital of Central South University, First Affiliated Hospital, Sun Yat-Sen University
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 9 Jan 2019 (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.
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.
Detailed description
The study is a multicenter prospective cohort study, aimed to explore underlying mechanisms of individual differences in drugs for coronary heart disease treatment and its association with adverse consequences.The genomic genotype, DNA methylation and metabolome of 1000 patients with coronary heart disease were determined using illumina high-density genotyping chip, high-throughput sequencing and high-resolution mass spectrometry. Blood exposures of statins and metoprolol and its metabolites was determined by UPLC-MS/MS.
The biological network using cross-omics analysis was reconstructed to identify potential causative key genes, bacteria, and endogenous metabolite targets that cause differences in individual responses. A machine identification algorithm selecting clinical factors and multi-omics targets was used to establish a predictive mathematical model.
A multi-center clinical cohort of 3000 coronal heart disease patients was used to verify the effects of various levels of omic targets on drug blood exposures, efficacy and toxic side effects. A comprehensive model based on multi-target combination of individualized drugs was constructed, and the predictive effect was clinically analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discovery cohort | – | Other: risk factors of adverse cardiovascular events, Other: multi-omics target discovery1000 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 | – | Other: risk factors of adverse cardiovascular events, Other: validation, Other: Predictive mathematical models3000 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- age: 18-80 years
- Chinese Han patients with coronary artery disease
- inpatients undergoing coronary angiography or percutaneous coronary intervention
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| risk factors of adverse cardiovascular eventsDuring 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 | Other | Discovery cohort, Validation corhort |
| multi-omics target discoveryGenome-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. | Other | Discovery cohort |
| validationThe 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. | Other | Validation corhort |
| Predictive mathematical modelsMachine 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. | Other | Validation corhort |
Primary outcome
Death
Time frame: from date of baseline examination until the date of first documented death,up to 48 months
All-cause death
4 secondary outcomes
MACE
Time frame: from date of baseline examination until the date of first documented cardiovascular events,up to 48 months
Bleeding
Time frame: from date of baseline examination until the date of first documented bleeding,up to 48 months
Statin-induced myopathy (SIM)
Time frame: from date of baseline examination until the date of first documented SIM,up to 48 months
CI-AKI
Time frame: more than 6 h within 48 h after Coronary Angiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Derived from this study: PubMed 36746922Chen 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.
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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.
Shilong Zhong, Ph.D principal investigator
Guangdong Provincial People's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Guangdong Provincial People's Hospital at 5 sites in China.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shilong Zhong, Ph.D (862083827812 ext. 51157, zhongsl@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: from date of baseline examination until the date of first documented death,up to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03797339, which also lists 1 linked publication.
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 12 Feb 2019.