| CTRI Number |
CTRI/2025/08/092733 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Diagnostic Accuracy Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of diagnostic test accuracy for the detection of blood clots in the heart |
|
Scientific Title of Study
|
A Comparative Study of Contrast CT and Transesophageal Echocardiography for Left Atrial Appendage Thrombus Detection
|
| 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 Satish Govind |
| Designation |
Head of Non-Invasive Cardiology |
| Affiliation |
Narayana Health |
| Address |
Narayana Institute of Cardiac Sciences,
Narayana Health, Bengaluru
Bangalore KARNATAKA 560099 India |
| Phone |
9845176922 |
| Fax |
|
| Email |
drsatish.govind@narayanahealth.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Satish Govind |
| Designation |
Head of Non-Invasive Cardiology |
| Affiliation |
Narayana Health |
| Address |
Ground Floor, Head of Department Office, Department of Non Invasive Cardiology, Narayana Institute of Cardiac Sciences 258/A, Bommasandra Industrial Area, Anekal Taluk, Hosur Road, Bangalore, Karnataka - 560099 Bangalore KARNATAKA 560099 India |
| Phone |
9845176922 |
| Fax |
|
| Email |
drsatish.govind@narayanahealth.org |
|
Details of Contact Person Public Query
|
| Name |
Pankaj Lakhwan |
| Designation |
Senior Clinical Scientist |
| Affiliation |
nference Labs Private Limited |
| Address |
3rd, 4th & 5th Floor, Indiqube Golf View Homes, 3rd Cross, Rustam Bagh Layout, NAL Wind Tunnel Main Road, Murugeshpalya, Bengaluru, Karnataka 560017
Bangalore KARNATAKA 421204 India |
| Phone |
09845176922 |
| Fax |
9654569437 |
| Email |
pankaj.lakhwan@anumana.ai |
|
|
Source of Monetary or Material Support
|
| nference Labs Private Limited,
3rd, 4th and 5th Floor, Indiqube Golf View Homes, 3rd Cross, Rustam Bagh Layout, NAL Wind Tunnel Main Road, Murugeshpalya, Bengaluru, Karnataka 560017, India |
|
|
Primary Sponsor
|
| Name |
nference Labs Private Limited |
| Address |
3rd 4th and 5th Floor Indiqube Golf View Homes 3rd Cross Rustam Bagh Layout NAL Wind Tunnel Main Road Murugeshpalya Bengaluru Karnataka 560017 |
| Type of Sponsor |
Other [Medical Device Industry] |
|
|
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 Satish Govind |
Narayana Institute of Cardiac Sciences |
Department of Non Invasive Cardiology, Ground Floor, Narayana Institute of Cardiac Sciences, 258/A, Bommasandra Industrial Area, Anekal Taluk, Hosur Road, Bangalore, Karnataka - 560099 Bangalore KARNATAKA |
09845176922
drsatish.govind@narayanahealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Medical Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I489||Unspecified atrial fibrillation and atrial flutter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients with atrial fibrillation or any other indications for LAA thrombus screening referred for routine Transesophageal echocardiogram
and Contrast Computed Tomography.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The accuracy, sensitivity and specificity of Transesophageal Echocardiography (TEE) in detecting left atrial appendage (LAA) thrombus, evaluated against Contrast Cardiac CT as the reference standard
|
Only at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlate anatomical types & location of left atrial appendage (LAA) identified by Transesophageal Echocardiography (TEE) in comparison with Contrast Cardiac CT as reference standard
|
Only at baseline |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
19/08/2025 |
| 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="0" Months="6" 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 investigation is a prospective, blinded comparison study in which adult patients (more than 18 years) requiring evaluation for left atrial appendage (LAA) thrombus will undergo both Transesophageal Echocardiography (TEE) and Contrast Cardiac CT as per standard of care. Patients are enrolled following confirmation that they meet inclusion criteria, such as having atrial fibrillation and being suitable candidates for both TEE and CT. After informed consent is obtained, TEE is performed under routine clinical conditions. Subsequently, within a defined interval to minimize clinical changes, patients receive a Contrast Cardiac CT according to standardized cardiac imaging protocols. The TEE interpreter is blinded to the CT findings, while the CT images are evaluated by a separate cardiac imaging specialist unaware of TEE results. The primary endpoint is the accuracy, sensitivity and specificity of TEE in detecting LAA thrombus, using CT as the reference standard. The sole secondary endpoint included in this study is correlating the anatomical types and location of the left atrial appendage (LAA) identified by TEE with those observed on CT, thereby assessing the consistency of structural characterization between the two modalities. All relevant findings are captured in a secure database for subsequent statistical analysis, enabling a direct comparison of imaging results and a clear evaluation of TEE performance under rigorous, blinded conditions. |