| CTRI Number |
CTRI/2024/02/062694 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Transesophageal Echocardiographic Assessment of the Walls of the Left Ventricle in Patients Undergoing Coronary artery bypass grafting. |
|
Scientific Title of Study
|
Transesophageal Echocardiographic Assessment of Regional Left Ventricular Function in Patients Undergoing Elective Surgical Revascularisation - A Prospective Observational 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 |
Anirudh T Patil |
| Designation |
Student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
M19 Jeevan Bima Nagar main road
Sector 11
HAL 3RD stage
Opposite to Laddoos sweets
Bangalore-560075
Nehru Nagar
Belagavi-590010
Belgaum
KARNATAKA
560075
India |
| Phone |
9353794986 |
| Fax |
|
| Email |
atpanirudh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shrangouda S Patil |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
KLE Dr. Prabhakar Kore Hospital and medical research centre
Department of Cardiac Anaesthesiology
Krishna floor
Nehrunagar
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9341101240 |
| Fax |
|
| Email |
drpatilsharan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shrangouda S Patil |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
KLE Dr. Prabhakar Kore Hospital and medical research centre
Department of Cardiac Anaesthesiology
Krishna floor
Nehrunagar
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9341101240 |
| Fax |
|
| Email |
drpatilsharan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| No Extra charges are levied on the patients. |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Nehrunagar
Belagavi -590010 |
| Type of Sponsor |
Private 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 Anirudh T Patil |
KLE Dr. Prabhakar Kore hospital and medical research centre, Cardiac anaesthesia department |
Nehrunagar
Belgaum
KARNATAKA |
9353794986
atpanirudh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
transesophageal echocardiography. |
placement of a transesophageal echocardiographic probe into the esophagus of the patient by a physician expert and assessment of regional left ventricular function and wall motion score indices pre and post revascularisation. This will be done within a duration of 5 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Normal sinus rhythm
2)Normal to mild LV dysfunction (ejection fraction  40%)
3)Patients with or without regional wall motion abnormality as identified on transthoracic echocardiography done pre-operatively. |
|
| ExclusionCriteria |
| Details |
1)patient refusal and contraindications to TEE.
2)patients with arrhythmias and conduction defects and permanent pacemaker in-situ.
3)emergency surgery
4)moderate to severe mitral regurgitation.
5)patients with left ventricular dysfunction. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To quantify the regional wall motion abnormality before surgical revascularisation using 2-Dimensional transesophageal echocardiography.
|
Immediately post revascularisation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the impact of surgical revascularization on left ventricular ejection fraction using Simpsons modified bi-plane method. |
immediately post revascularisation |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/02/2024 |
| 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)
|
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
|
After induction of anaesthesia a transesophageal echocardiography probe will be introduced by a trained physician into the esophagus of the patient. The 2-dimensional echocardiographic data will be assessed by using mid-esophageal (4 chamber, 2 chamber, and long axis) and transgastric (basal, midpapillary and apical) views. The views will be assessed by the 17-segment Americal Heart Association model and will be scored from 1 to 5 (normokinesis to dyskinesis). The mean of the 17 segments will be taken and a wall motion score will be calculated and higher the wall motion score index, indicates higher the number of hibernating segments. The left ventricular function will be assessed pre and post-revascuarisation by using the modified Simpsons bi-plane method. Thus the impact of surgical revascularisation will be assessed, |