| CTRI Number |
CTRI/2024/07/070720 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Metabolic And Inflammatory Indicators In Patients With High Cardiac Marker Levels. |
|
Scientific Title of Study
|
Correlation of Serum Uric Acid / Hdl-Cholesterol Ratio And Inflammatory Markers in Patients with High Troponin-T Levels – An Observational Case Control Study |
| 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.Vijay Venkataiah |
| Designation |
Associate Professor |
| Affiliation |
VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Biochemistry, VIMS, Cantonment, Ballari-583104, Karnataka, India
Bellary
KARNATAKA
583104
India |
| Phone |
9742888245 |
| Fax |
|
| Email |
dr.venkat.vi22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Vijay Venkataiah |
| Designation |
Associate Professor |
| Affiliation |
VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Biochemistry
VIMS, Cantonment, Ballari-583104,
Karnataka, India
Bellary
KARNATAKA
583104
India |
| Phone |
09742888245 |
| Fax |
|
| Email |
dr.venkat.vi22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Vijay Venkataiah |
| Designation |
Associate Professor |
| Affiliation |
VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Biochemistry
VIMS, Cantonment, Ballari-583104
Karnataka India
Bellary
KARNATAKA
583104
India |
| Phone |
9742888245 |
| Fax |
|
| Email |
dr.venkat.vi22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vijayanagar Institute of Medical Sciences, Ballari-583104, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Vijayanagar Institute of Medical Sciences Ballair |
| Address |
Department of Biochemistry
VIMS Cantonment Ballari-583104 |
| 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 |
| DrVijay Venkataiah |
MCH Hospital VIMS Ballari |
Central Diagnostic laboratory
Department of Biochemistry
Room No. 32
Bellary
KARNATAKA |
9742888245
dr.venkat.vi22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VIMS INSTITUTIONAL ETHICS COMMITTE, BALLARI |
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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with chest pain coming to emergency or casualty OPD with probable diagnosis of ischemic heart disease. |
|
| ExclusionCriteria |
| Details |
Pregnant women and participants who are known cases of Ischemic heart diseases/respiratory diseases/ renal disorders/ gout/cancer/immunological disorders are excluded from the study.
Participants with fever are excluded from the study. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increased Uric acid and HDL ratio [UHR] may be a risk factor for Myocardial infarction [MI]. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increased UHR in high risk patients for MI like Diabetes mellitus, metabolic syndrome etc can be a predictor marker for MI in these patients. |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
01/08/2024 |
| 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)
|
Open to Recruitment |
| 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
|
Hyperuricemia is
associated with metabolic syndrome, Diabetes mellitus (DM) and its
complications. Low HDL-C is associated with high risk for
atherosclerosis and myocardial infarction. Increased Uric
acid/HDL-C ratio (UHR) is associated with, metabolic syndrome,
DM and its complications, and Non-alcoholic fatty liver disease. UHR
has been shown as an new biomarker for evaluating interactions between
inflammatory and anti-inflammatory substances in blood.
In the year 2020, the prevalence of MI in Indians was 21.4% for diabetics
and 11% for non-diabetics. Metabolic inflammation or Chronic low
grade systemic inflammation (also called as adipose inflammation) is one of the
risk factor for pathogenesis of Myocardial Infarction (MI).
MI is a complication of metabolic disorders like DM and Metabolic syndrome. And
Troponin T is a commonly used cardiac marker for diagnosis of MI. Troponin T concentration is
significantly associated with the incidence of cardiovascular death and heart
failure, and also a predictor of acute MI.
Hence this study was under taken to assess the correlation between Uric
acid/HDL-C ratio and inflammatory markers with myocardial infarction indicator,
ie Troponin T. |