| CTRI Number |
CTRI/2019/11/022142 [Registered on: 26/11/2019] Trial Registered Retrospectively |
| Last Modified On: |
22/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Measuring the body fat content in people who are being tested for presence of blockage in the arteries of their heart |
|
Scientific Title of Study
|
Assessment of body composition parameters in patients undergoing a coronary angiogram for suspected coronary artery disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhiren Punja |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical College Manipal, Manipal Academy of Higher Education |
| Address |
Department of Physiology
Kasturba Medical College
Manipal
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
dhiren.punja@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dhiren Punja |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical College Manipal Manipal Academy of Higher Education |
| Address |
Department of Physiology
Kasturba Medical College
Manipal
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
dhiren.punja@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dhiren Punja |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical College Manipal, Manipal Academy of Higher Education |
| Address |
Department of Physiology
Kasturba Medical College
Manipal
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
dhiren.punja@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical college
Manipal |
|
|
Primary Sponsor
|
| Name |
Dhiren Punja |
| Address |
Department of Physiology
Kasturba Medical College
Manipal -576104 |
| Type of Sponsor |
Other [Individual] |
|
|
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 |
| Dhiren Punja |
Kasturba hospital |
Catheterization lab,
Department of Cardiology,
Kasturba Hospital
Manipal -576104
Udupi
KARNATAKA |
9845558131
dhiren.punja@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, (2) ICD-10 Condition: I209||Angina pectoris, unspecified, Patients who are suspected to have coronary artery disease and are undergoing an angiogram , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients who will undergo a coronary angiogram for suspected coronary artery disease |
|
| ExclusionCriteria |
| Details |
Patients with implanted pacemakers or cardioverter defibrillators
Pregnant women
Patients in whom accurate measurements of body composition are not possible:
Electrolyte imbalances
Renal failure
Patients on steroids or diuretics
Patients with edema
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Body Fat % and fat weight , Lean Mass % and lean mass, Body Fat Mass Index (BFMI), Fat-Free mass index and visceral fat % |
At the time of diagnosis of the coronary artery disease |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
History of smoking and alcohol intake
Family history of coronary artery disease
Blood pressure
Body mass index and waist circumference
Values of lab investigations done before the coronary angiogram such as blood glucose levels and lipid profile
|
At the time of diagnosis of the coronary artery disease |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "201"
Final Enrollment numbers achieved (India)="201" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/09/2016 |
| Date of Study Completion (India) |
15/11/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a case control study designed to compare the body composition parameters between patients with evidence of coronary artery disease (CAD) of varying severities and patients with no evidence of coronary artery disease as observed in an angiogram .It will begin as a pilot study of 2 months duration and will involve comparing 15 CAD patients with 15 patients without CAD Coronary artery disease is known to be associated with dyslipidemia, which we hypothesize could be caused by alterations in the body fat composition. The patients included in the study will be those who are undergoing coronary angiogram in Kasturba hospital in Manipal. An instrument called Bodystat 1500MDD will be used to asses body composition parameters such as Body Fat % and fat weight , Lean Mass % and lean mass, Body Fat Mass Index (BFMI), Fat-Free mass index and visceral fat % in the two groups of patients |