| CTRI Number |
CTRI/2023/08/056382 [Registered on: 10/08/2023] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of thyroid function tests and chemical markers in heart disease (myocardial infarction) patients |
|
Scientific Title of Study
|
A study of thyroid function tests and inflammatory response markers in acute myocardial infarction patients |
| 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 Neethu Mary George |
| Designation |
Junior Resident (PG) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology
Maulana Azad Medical College
Bahadur shah zafar marg
New Delhi - 110002
Central
DELHI
110002
India |
| Phone |
9846027047 |
| Fax |
|
| Email |
neethumarygeorge4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dayaram Haldwani |
| Designation |
Director Professor |
| Affiliation |
Maulana azad medical college |
| Address |
Department of Physiology
Maulana Azad Medical College
Bahadur shah zafar marg
New Delhi - 110002
Central
DELHI
110002
India |
| Phone |
9810622392 |
| Fax |
|
| Email |
drhaldwani@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dayaram Haldwani |
| Designation |
Director Professor |
| Affiliation |
Maulana azad medical college |
| Address |
Department of Physiology
Maulana Azad Medical College
Bahadur shah zafar marg
New Delhi - 110002
Central
DELHI
110002
India |
| Phone |
9810622392 |
| Fax |
|
| Email |
drhaldwani@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College, New Delhi |
| Address |
Maulana Azad Medical College
Bahadur shah zafar marg
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 Neethu Mary George |
Maulana Azad medical college and associated LNJP and GIPMER hospital |
Maulana Azad Medical College
Bahadur shah zafar marg
New Delhi - 110002
Central
DELHI |
9846027047
neethumarygeorge4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee , Maulana azad Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I213||ST elevation (STEMI) myocardial infarction of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with acute ST elevation myocardial infarction (STEMI) and admitted
within 72 hours of onset of chest pain. |
|
| ExclusionCriteria |
| Details |
1. Previous history of myocardial infarction.
2. Pre-existing thyroid illness.
3. On anticoagulant therapy or taking any thyroid related drug.
4. Previous history of cardiovascular disorder.
5. Cancer, severe renal or liver failure, and inflammatory or infectious disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The proportion of thyroid dysfunction among myocardial infarction patients less than
45 years of age. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The proportion of altered inflammatory markers among MI patients less than 45 years
of age.
|
baseline |
The proportion of altered adiponectin levels among MI patients less than 45 years of
age. |
baseline |
The correlation between adiponectin levels, hs-CRP & thyroid function status in MI
patients less than 45 years of age. |
baseline |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "57"
Final Enrollment numbers achieved (India)="57" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2023 |
| Date of Study Completion (India) |
30/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/08/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
In this PG thesis, we are planning to study about the thyroid status as well as inflammatory response in acute myocardial infarction patients less than 45 years of age. The study will be conducted in Maulana Azad Medical College and associated LNJP and GIPMER hospitals. |