Coronary Heart Disease Clinical Trial
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.
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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