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Clinical Trials/CTRI/2025/08/093773
CTRI/2025/08/093773Not yet recruitingNot Applicable

Genotyping and Association study of Candidate Biomarker Gene Polymorphisms with Coronary Artery Disease (CAD) patients, in a tertiary care centre of Kumaon region. A case control

Department Of Health Research (DHR-ICMR)1 site in 1 country300 target enrollmentStarted: September 8, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
300
Locations
1
Primary Endpoint
The anticipated outcomes is to find relationship between genetic polymorphisms in various candidate genes on the development and progression of CAD. Also to establish correlations between the genotypes of candidate genes and various cardiac function tests in CAD patients. The research will also yield statistical data regarding the polymorphisms of these candidate genes in the context of CAD, thereby contributing to the understanding of their potential as biomarkers for the disease.

Study Overview

Brief Summary

The aim of this research is to investigate the genetic variations associated (SNPs) with several key genes in both patients diagnosed with coronary artery disease (CAD) and healthy control subjects. Firstly, the study aims to analyze the polymorphism in five candidate genes (LDL R SMARCA4, LPA, LOX1, PCSK9 and eNOS genes) and its potential impact on CAD. Lastly, the study aims to establish correlations between the identified polymorphisms in these candidate biomarker genes and various CAD test parameters, as well as other relevant anthropometric data, to enhance the understanding of genetic influences on coronary artery disease. The research will also yield statistical data regarding the polymorphisms of these candidate genes in the context of CAD, thereby contributing to the understanding of their potential as biomarkers for the disease. Ultimately, the database generated from this study will serve as a valuable resource for guiding future research initiatives in this area within the Kumaon region of Uttarakhand. The overarching goal is to not only contribute to the scientific community’s understanding of CAD but also to translate these findings into actionable strategies that can transform the management and treatment of this prevalent condition.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • For cases
  • Patients diagnosed with CAD as per clinician advise
  • Age not less than 18 years
  • Given informed consent For Control
  • Age not less than 18 years, and age and sex matched with case groups
  • Negative angiogram or cases with no history of CAD, may be taken for control cases
  • Belong to North India (by descent)
  • Given informed consent.

Exclusion Criteria

  • For Cases
  • Acute or chronic infection
  • Pregnancy
  • Malignancy
  • Autoimmune diseases
  • Mental illnesses
  • Age less than 18 years
  • Declined to give informed consent For Control
  • Are suffering from any other communicable or chronic disease such as AIDS, tuberculosis, hepatitis, etc.
  • Any history CAD
  • Pregnancy
  • Malignancy
  • Alcoholic, smokers and tobacco consumers
  • Age less than 18 years
  • Autoimmune diseases
  • Declined to give informed consent.

Outcomes

Primary Outcomes

The anticipated outcomes is to find relationship between genetic polymorphisms in various candidate genes on the development and progression of CAD. Also to establish correlations between the genotypes of candidate genes and various cardiac function tests in CAD patients. The research will also yield statistical data regarding the polymorphisms of these candidate genes in the context of CAD, thereby contributing to the understanding of their potential as biomarkers for the disease.

Time Frame: 36 months

Secondary Outcomes

  • ii. The results obtained from this study would help in the assessment of role of genetic polymorphism in Lipoprotein A gene in development & progression of CAD in patients of kumaon region.(30 months)
  • iii. The results obtained from this study would help in the assessment of role of genetic polymorphism in Lectin like oxidized-LDL receptor-1 (LOX1) gene in development & progression of CAD in patients of kumaon region.(30 months)
  • iv. The results obtained from this study would help in the assessment of role of genetic polymorphism in Proprotein convertase subtilisin kexin type 9 (PCSK9) gene in development & progression of CAD in patients of kumaon region(30 months)
  • v. The results obtained from this study would help in the assessment of role of genetic polymorphism in Endothelial Nitric Oxide Synthase (eNOS) gene in development & progression of CAD in patients of kumaon region.(30 months)
  • vi. It would help to evaluate the correlation of above candidate genes genotype with various cardiac function tests in CAD patients.(30 months)
  • vii. Statistical information will be obtained from this study regarding above candidate genes polymorphism in CAD patients.(30 months)
  • viii. This study will help in evaluation the role of above candidate genes as a biomarker in CAD.(30 months)
  • ix. The database from this study will help in planning future research in this field from Kumaon region of Uttarakhand.(30 months)

Investigators

Sponsor
Department Of Health Research (DHR-ICMR)
Sponsor Class
Government funding agency
Responsible Party
Principal Investigator
Principal Investigator

Somesh Mehra

Multidisciplinary Research Unit (MRU), Government Medical College Haldwani

Study Sites (1)

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