| CTRI Number |
CTRI/2024/08/072105 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of inflammatory mediators RAGE, sRAGE for developing atherosclerosis in patients with Diabetes Mellitus |
|
Scientific Title of Study
|
The role of receptor for advanced glycation end products (RAGE’s) and soluble RAGE (sRAGE) in Coronary Artery Disease patients with Diabetes Mellitus |
| 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 Mohit Singh |
| Designation |
Post Graduate Resident |
| Affiliation |
GB Pant Hospital, GIPMER |
| Address |
Department of Biochemistry, Room no 422 A block 4th floor GB Pant hospital
GB pant hospital, Delhi 110002
Central
DELHI
110002
India |
| Phone |
9354264572 |
| Fax |
|
| Email |
mohit99101@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Kumar Dabla |
| Designation |
Professor, Biochemistry |
| Affiliation |
GB Pant Hospital, GIPMER |
| Address |
Department of Biochemistry, Room no A 417, A block, 4th floor, GB Pant Hospital
GB pant hospital, Delhi 110002
Central
DELHI
110002
India |
| Phone |
9718592467 |
| Fax |
|
| Email |
pradeep.dabla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Singh |
| Designation |
Post Graduate Resident |
| Affiliation |
GB Pant Hospital, GIPMER |
| Address |
Department of Biochemistry, Room No A 422, A block, 4th floor, GB Pant hospital
GB pant hospital, Delhi 110002
Central
DELHI
110002
India |
| Phone |
9354264572 |
| Fax |
|
| Email |
mohit99101@gmail.com |
|
|
Source of Monetary or Material Support
|
| GB Pant postgraduate institute of medical education and research, Delhi - 110002, India |
|
|
Primary Sponsor
|
| Name |
GB Pant Hospital |
| Address |
GB Pant Hospital and GIPMER, Jawahar lal nehru marg , 64 khamba, Raj ghat 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 Pradeep Kumar Dabla |
GB Pant Hospital |
Department of Biochemistry, Room No 417, A block , 4th floor, GB Pant hospital, Central delhi 110002
Central
DELHI |
9718592467
pradeep.dabla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITAL (Lok nayak, GB pant Institute of post graduate medical education and research (GIPMER), Guru nanak eye centre, New delhi - 110002 ) INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with confirmed cases of Atherosclerosis with Coronary Angiography with more than 50% stenosis in atleast one vessel |
|
| ExclusionCriteria |
| Details |
Patients with Acute Coronary Syndrome such as Myocardial Infarction and Patients with Cardiac diseases such as Valvular diseases and Cardiomyopathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum levels of RAGE and sRAGE in Coronary artery disease patients with and without diabetes mellitus |
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| RAGE gene expression and its correlation with blood levels of RAGE and sRAGE and patient phenotype in above patient groups |
1 year |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
19/08/2024 |
| 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
|
Coronary artery disease and Myocardial Infarction is one of the major cause of premature death worldwideadvanced glycation end products is known to be a factor in increasing and starting atherosclerosis in patients of Diabetes Mellitus leading to Myocardial Infarction. Activation of Receptor for Advanced glycation end products (RAGE) is also being considered as a factor for worsening Atherosclerosis By this study we are trying to corelate the Levels and expression of RAGE gene in patients with and without diabetes mellitus and levels of atherosclerosis in patients with CAD The study is divided into 2 groups .Group 1 consists of 80 Patients with angiographically proven Coronary Artery disease (CAD) with Diabetes Mellitus and group 2 consists of 80 Patients with CAD without diabetes mellitus . The study is going to be conducted in GIPMER delhi |