| CTRI Number |
CTRI/2025/10/095826 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the heart scan of bypass surgery patients using different temperature technique. |
|
Scientific Title of Study
|
Comparison of Echocardiographic outcome parameters following normothermic and hypothermic On- pump coronary artery bypass grafting surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sowndarya P |
| Designation |
2nd year MSc Perfusion Technology student |
| Affiliation |
Manipal College Of Health Professions, Manipal |
| Address |
Room no. 413, 4th floor, Perfusion Technology Program, Manipal College Of Health Professions, Manipal, Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9626760396 |
| Fax |
|
| Email |
sowndaryagps16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Glory Mini Mol |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions, MAHE, Manipal - 576104 |
| Address |
Room no. 413, 4th floor, Perfusion Technology Program, Manipal College of Health Professions, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7397590555 |
| Fax |
|
| Email |
glory.a@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ms Glory Mini Mol |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions, MAHE, Manipal - 576104 |
| Address |
Room no. 413, 4th floor, Perfusion Technology Program, Manipal College of Health Professions, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7397590555 |
| Fax |
|
| Email |
glory.a@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Cardiovascular and Thoracic Surgery, Room no. 32, 3rd floor OPD building, Kasturba Hospital, Manipal, Udupi, Karnataka - 576104 |
|
|
Primary Sponsor
|
| Name |
Department of Cardiovascular and Thoracic Surgery |
| Address |
Room no. 32, 3rd floor OPD building, Kasturba Hospital, Manipal. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Guruprasad Rai D |
Kasturba Hospital |
Department of Cardiovascular and Thoracic Surgery, Room no. 32, 3rd floor, OPD building, Manipal - 576104
Udupi
KARNATAKA |
9886730726
drgururai13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I20-I25||Ischemic heart diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing Elective CABG |
|
| ExclusionCriteria |
| Details |
Emergency surgeries
Other cardiac surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study to observe and measure the Post- operative Echocardiography parameters such as LVEF, TAPSE, LVSD, LVDD, Valve function, Wall motion abnormality. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
27/10/2025 |
| 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="2"
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
|
This study is done to observe and measure the post operative echocardiography outcome parameters such as left ventricular ejection fraction, tricuspid annular plane systolic excursion, wall motion abnormality, valve function, left ventricular systolic dysfunction, left ventricular diastolic dysfunction between the two temperature techniques of normothermic and hypothermic on- pump coronary artery bypass grafting surgery patients. |