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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
| West China Hospital | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| risk factors of adverse cardiovascular events | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Death | All-cause death | from date of baseline examination until the date of first documented death,up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | MACE was defined as the occurrence of cardiac death, nonfatal myocardial infarctions, coronary revascularisation and cerebral infraction. | from date of baseline examination until the date of first documented cardiovascular events,up to 48 months |
| Bleeding |
| Measure | Description | Time Frame |
|---|---|---|
| SYNTAX score | It is mainly used for the treatment of left main coronary artery lesions and/or three-vessel lesions.Patients with a score of ≥33 are recommended for CABG. Patients with a score between 23 and 32 can choose either PCI or CABG. Patients with a score of ≤22 are recommended for PCI and CABG. | more than 6 h within 48 h after Coronary Angiography |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shilong Zhong, Ph.D | Contact | 862083827812 | 51157 | zhongsl@hotmail.com |
| Juer Liu, master | Contact | 13430267895 | 51157 | liujesysu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shilong Zhong, Ph.D | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong General Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36746922 | Derived | 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. |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D054928 | Validation Studies as Topic |
| ID | Term |
|---|---|
| D005069 | Evaluation Studies as Topic |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| OTHER |
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Feces,urine,and blood are from patients with coronary heart disease.
|
| multi-omics target discovery | Other | 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. |
|
| validation | Other | 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 models | Other | 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. |
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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. |
| 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. | 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 | more than 6 h within 48 h after Coronary Angiography |
| The First Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| XiangYa Hospital Central South University | Recruiting | Changsha | Hunan | 410008 | China |
|
| Renji Hospital Affiliated to Shanghai Jiaotong University | Recruiting | Shanghai | Shanghai Municipality | 200233 | China |
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| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
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| D017530 | Health Care Quality, Access, and Evaluation |