| CTRI Number |
CTRI/2024/08/071872 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To estimate the methylation status and levels of cytokine TNFRSF4 in patients suffering from myocardial infarction (MI) |
|
Scientific Title of Study
|
Methylation status and levels of tumor necrosis factor receptor superfamily member 4 (TNFRSF4) in myocardial infarction |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhawna Mahajan |
| Designation |
Professor |
| Affiliation |
G.B.Pant Institute of Postgraduate Medical Education and Research Hospital (GIPMER) |
| Address |
Department of Biochemistry Academic Block 4th floor Room No 413 Govind Ballabh Pant Insititute Of Postgraduate Medical Education And Research (GIPMER) ,1, Jawaharlal Nehru Marg New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
9718599054 |
| Fax |
- |
| Email |
bhawna172@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renu Sehrawat |
| Designation |
Post Graduate Resident |
| Affiliation |
G.B.Pant Institute of Postgraduate Medical Education and Research Hospital (GIPMER) |
| Address |
Department of Biochemistry Academic Block 4th floor Room No 422 Govind Ballabh Pant Insititute Of Postgraduate Medical Education And Research (GIPMER) ,1, Jawaharlal Nehru Marg New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
9354622437 |
| Fax |
- |
| Email |
renusehrawat0907@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhawna Mahajan |
| Designation |
Professor |
| Affiliation |
G.B.Pant Institute of Postgraduate Medical Education and Research Hospital (GIPMER) |
| Address |
Department of Biochemistry Academic Block 4th floor Room No 413 Govind Ballabh Pant Insititute Of Postgraduate Medical Education And Research (GIPMER) ,1, Jawaharlal Nehru Marg New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
9718599054 |
| Fax |
- |
| Email |
bhawna172@gmail.com |
|
|
Source of Monetary or Material Support
|
| G.B.Pant Institute of Postgraduate Medical Education and Research Hospital (GIPMER)
1 Jawaharlal Nehru Marg 64 Khamba Raj Ghat New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Govind Ballabh Pant Hospital |
| Address |
Govind Ballabh Pant Hospital 1 Jawaharlal Nehru Marg 64 Khamba Raj Ghat New Delhi 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Bhawna Mahajan |
Govind Ballabh Pant Insititute Of Postgraduate Medical Education And Research (GIPMER) |
Department of Biochemistry Academic Block 4th floor Room No 420 Govind Ballabh Pant Insititute Of Postgraduate Medical Education And Research (GIPMER) ,1, Jawaharlal Nehru Marg New Delhi 110002
New Delhi
DELHI |
9718599054
bhawna172@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maulana Azad Medical College and Associated Hospital (Lok Nayak, G.B. Pant Institute of Postgraduate Medical Education and Research Hospital (GIPMER), Guru Nanak Eye Centre, New Delhi 110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Observational |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Cases
1. Age more than 18 years
2. Patient having MI according to fourth universal definition of MI.
Controls
More than 18years of age, sex matched. |
|
| ExclusionCriteria |
| Details |
Cases
1 Known case of Autoimmune disease
2 Known case of Leukemias
3 Known case of Rheumatic heart disease
4 Known case of any other systematic illness like
5 Pregnant females and lactating females
Controls
Hypertensive Smokers and Diabetic Pregnant females and lactating females patients with any systematic illness like any cancer
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Methylation status of TNFRSF4 gene in patients suffering from Myocardial infarction.
2. Levels of TNFRSF4 in patients suffering from Myocardial infarction
|
1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Levels of TNFRSF4 in patients suffering from Myocardial infarction |
1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/08/2024 |
| 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="1"
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 most common form of Coronary heart disease (CHD)
is Myocardial Infarction (MI). It is responsible for over 15% of mortality each
year, majority of people suffering from non-ST-segment elevation myocardial
infarction (NSTEMI) than ST-segment elevation myocardial infarction (STEMI).
According to World health organization (WHO), it is estimated that 7.5
million deaths were due to CHD in 2015.
MI is caused by
decreased or complete cessation of blood flow to a portion of the myocardium. Patients
can present with chest discomfort or pressure that can radiate to the neck,
jaw, shoulder, or arm. MI may be associated with electrocardiogram (ECG)changes
and elevated biochemical markers such as cardiac troponins.
The TNFSF4 (tumor necrosis factor ligand superfamily
member 4) gene is expressed by activated B cells, endothelial cells, and
activated CD4+ and CD8+ T-cells. The TNFRSF Rc, TNFRSF4 (tumor necrosis factor
receptor superfamily member 4) is also expressed on activated T cells. When
gets activated, T cells produce proinflammatory cytokines, which are largely
responsible for plaque rupture and thrombus formation. The TNFSF4/TNFRSF4
pathway plays a role in atherosclerosis and atherosclerotic disease.
DNA methylation is an epigenetic mechanism
consisting in which chemical modifications of cytosines, mostly followed by
guanines (CpGs). Epigenome-wide association studies (EWASs) make it possible to
find DNA methylation biomarkers of different traits and outcomes. |