| CTRI Number |
CTRI/2024/03/063720 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the Association of calcium score and physical activity in cardiac patients |
|
Scientific Title of Study
|
Investigation of the association between physical activity and coronary artery calcium scores in individual referred for cardaic screening. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shashidhar Gudagur |
| Designation |
MSc Student |
| Affiliation |
Manipal College of Health Professions, MAHE, Manipal. |
| Address |
Department of Medical Imaging Technology, Manipal College of Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
7892465840 |
| Fax |
|
| Email |
shashidhar.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Shashidhar Gudagur |
| Designation |
MSc Student |
| Affiliation |
Manipal College of Health Professions, MAHE, Manipal. |
| Address |
Department of Medical Imaging Technology, Manipal College of Health Professions, MAHE, Manipal.
KARNATAKA
576104
India |
| Phone |
7892465840 |
| Fax |
|
| Email |
shashidhar.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mr Visakh T |
| Designation |
Assistant Professor Senior Scale |
| Affiliation |
Manipal College of Health Professions, MAHE, Manipal. |
| Address |
Department of Medical Imaging Technology, Manipal College of Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9008760165 |
| Fax |
|
| Email |
visakh.t@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Kasturba Medical College, MAHE, Manipal |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 |
| DrPrakashini K |
Kasturba Hospital |
Department of Radio diagnosis
and imaging
Room No 2 Main CT Scan
Udupi
KARNATAKA |
9845053325
prakashini.k@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 |
| Healthy Human Volunteers |
. |
| Patients |
(1) ICD-10 Condition: I798||Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All the patients referred for CT Calcium score/CCTA
CAD |
|
| ExclusionCriteria |
| Details |
Patient with coronary artery stents
patient already on statin theraphy
physical disabilities
Inability of physical activity due to mobility issue
participants having chronic breathing difficulties |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
outcome measures
Calcium Score Level
Physical Activity Level |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
18/03/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 International Physical Activity Questionnaire (IPAQ) will be provided to assess the current physical activity levels and Heart rate should be monitored. With this the demographic details will also be collected. Scan will be perform using routine protocol. Patient should follow breathing instruction. Firstly, we acquire dual surview for planning for Ca score axial in 2.5mm thickness. The recon phase will be 75%. Filter should be CB. Windowing will be in abdomen window. All the images will be transferred to ISP server for image analysis. Calcium score will be calculated using Agatston score and summing all the calcium score as percentile or score. |