| CTRI Number |
CTRI/2025/08/093773 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
The genotyping and association study of candidate biomarker gene variants in CAD patients at a tertiary care hospital, in Kumaon region, to find the relationships between these gene variants and several heart function tests in CAD patients, ultimately to enhance the effective CAD management. |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Somesh Mehra |
| Designation |
Research Scientist II (Scientist C) |
| Affiliation |
Multidisciplinary Research Unit (MRU), Government Medical College Haldwani |
| Address |
Multidisciplinary Research Unit (MRU), 2nd Floor Pathology Building, Government Medical College, Rampur Road, Haldwani 263139 U.K.
Nainital
UTTARANCHAL
263139
India |
| Phone |
9410431774 |
| Fax |
|
| Email |
drsomeshmehra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Somesh Mehra |
| Designation |
Research Scientist II (Scientist C) |
| Affiliation |
Multidisciplinary Research Unit (MRU), Government Medical College Haldwani |
| Address |
Multidisciplinary Research Unit (MRU), 2nd Floor Pathology Building, Government Medical College, Rampur Road, Haldwani 263139 U.K.
UTTARANCHAL
263139
India |
| Phone |
9410431774 |
| Fax |
|
| Email |
drsomeshmehra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Somesh Mehra |
| Designation |
Research Scientist II (Scientist C) |
| Affiliation |
Multidisciplinary Research Unit (MRU), Government Medical College Haldwani |
| Address |
Multidisciplinary Research Unit (MRU), 2nd Floor Pathology Building, Government Medical College, Rampur Road, Haldwani 263139 U.K.
UTTARANCHAL
263139
India |
| Phone |
9410431774 |
| Fax |
|
| Email |
drsomeshmehra@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Department Of Health Research (DHR-ICMR) |
|
|
Primary Sponsor
|
| Name |
Department Of Health Research (DHR-ICMR) |
| Address |
Department of Health Research, Ministry of Health and Family Welfare 2nd Floor, IRCS Building,
1, Red Cross Road, New Delhi - 110001. |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arun Joshi |
Dr. Susheela Tiwari Government Hospital, Government Medical College, Haldwani |
Department of Medicine, Dr. Susheela Tiwari Government Hospital, Rampur Road, Haldwani (Nainital – 263129) Uttarakhand.
Nainital
UTTARANCHAL |
7351726777
arunjoshi1960@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College, Haldwani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (2) ICD-10 Condition: I70-I79||Diseases of arteries, arterioles and capillaries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
For cases
1. Patients diagnosed with CAD as per clinician advise
2. Age not less than 18 years
3. Given informed consent
For Control
1. Age not less than 18 years, and age and sex matched with case groups
2. Negative angiogram or cases with no history of CAD, may be taken for control cases
3. Belong to North India (by descent)
4. Have epidemiologically similar data to the patients
5. Given informed consent |
|
| ExclusionCriteria |
| Details |
For Cases
1. Acute or chronic infection
2. Pregnancy
3. Malignancy
4. Autoimmune diseases
5. Mental illnesses
6. Age less than 18 years
7. Declined to give informed consent
For Control
1. Are suffering from any other communicable or chronic disease such as AIDS, tuberculosis, hepatitis, etc.
2. Any history CAD
3. Pregnancy
4. Malignancy
5. Mental illnesses
6. Alcoholic, smokers and tobacco consumers
7. Age less than 18 years
8. Autoimmune diseases
9. Declined to give informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
36 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |