| CTRI Number |
CTRI/2024/05/067897 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Diagnostic |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Analyzing heart tissues for predicting heart (cardiac) conditions |
|
Scientific Title of Study
|
Multi-modal characterization of endomyocardial biopsy
specimen for predicting myocardial fibrosis and heart failure |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasanna Simha Mohan Rao |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sri Jayadeva Institute of Cardiovascular Sciences and Research |
| Address |
Department of Cardiothoracic and Vascular Surgery, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
9740010294 |
| Fax |
|
| Email |
prasannasimha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Twinkle |
| Designation |
Ph.D. Scholar |
| Affiliation |
Indian Institute of Science (IISc) Bangalore |
| Address |
C/O Dr. Hardik J. Pandya, Department of Electronic Systems Engineering, Indian Institute of Science, Bangalore-560012
Bangalore
KARNATAKA
560012
India |
| Phone |
9463240228 |
| Fax |
|
| Email |
twinkle1@iisc.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Prasanna Simha Mohan Rao |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sri Jayadeva Institute of Cardiovascular Sciences and Research |
| Address |
Department of Cardiothoracic and Vascular Surgery, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
9740010294 |
| Fax |
|
| Email |
prasannasimha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Institute of Science Bangalore, Address: CV Raman Road, Bengaluru, Karnataka-560012 |
| Sri Jayadeva Institute of Cardiovascular Sciences and Research,
Address: B-8, B T M I Stage, Marenahalli Rd, KEB Colony, Jayanagar 9th Block, Jayanagar, Bengaluru, Karnataka-560041 |
|
|
Primary Sponsor
|
| Name |
Sri Jayadeva institute of Cardiovascular Sciences and research |
| Address |
Prasanna Simha Mohan Rao Professor
and Head of Unit Department of
Cardiovascular Surgery Sri Jayadeva
Institute of Cardiovascular Sciences and
Research Bangalore |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hardik J Pandya |
Indian Institute of Science (IISc) |
Room no. 320, Department of Electronic Systems Engineering; Address: IISc, CV Raman Road, Bangalore, Karnataka-560012
Bangalore
KARNATAKA |
8860255254
hjpandya@iisc.ac.in |
| Dr Prasanna Simha Mohan Rao |
Sri Jayadeva Institute of Cardiovascular Sciences and Research |
Department of Cardiothoracic and Vascular Surgery; Address: B-8, B T M I Stage,Marenahalli Rd, KEB Colony, Jayanagara 9th Block, Jayanagar, Bengaluru, Karnataka, 560041
Bangalore
KARNATAKA |
9740010294
08022977395
prasannasimha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Indian Institute of Sciences institutional Human Ethics Commitee |
Approved |
| Sri Jayadeva Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I349||Nonrheumatic mitral valve disorder, unspecified, (2) ICD-10 Condition: I059||Rheumatic mitral valve disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cadaveric tissue and Homograft Donor tissue |
Characterization of myocardial tissues using different modalities such as optical, electrical, and thermal. No intervention is involved for the cadaveric tissues. One tissue sample each from left ventricle and right ventricle will be excised from the cadaver for the study. |
| Intervention |
Muscle Biopsy intraoperatively |
Characterization of myocardial tissues using different modalities such as optical, electrical and thermal. We will be biopsying once, so atmost one biopsy sample each from left ventricle and right ventricle will be used for the study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with heart failure and
myocardial fibrosis who consent to contribute endomyocardial
biopsy specimen during cardiac surgery at Sri Jayadeva
Institute of Cardiovascular Sciences and Research.
Exclusion criteria details: Multiorgan failure |
|
| ExclusionCriteria |
| Details |
Patients with valvular disease not undergoing cardiac surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Extent of myocardial fibrosis and altered heart tissue physical
characteristics. |
At time of tissue characterization at end of study of 3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical outcome related to degree of fibrosis and physical characteristics of tissue |
3 years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
03/06/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
During a cardiovascular disorder, remodeling of heart tissues occurs. If this remodeling is permanent, it can cause organ malfunction and even death, if left untreated. Therefore, if the state of the heart tissues is analyzed at an early stage of the disease, it can be lifesaving. Right ventricular dysfunction (RVD) is known to have prognostic significance for several cardiovascular conditions such as rheumatic heart disease, myocardial infarction, and heart failure. Therefore, the physiological changes of ventricular myocardium can be characterized to predict cardiovascular conditions which can be life-threatening to the patients. Due to the unique morphological and physiological properties of the ventricular myocardium and the clinical significance of ventricular failure, there is a need to explore specific mechanisms of myocardial fibrosis and interstitial remodeling using various characterization methods. We have already developed a portable diagnostic tool for characterizing biopsy tissues based on its electrical, optical, acoustic, and mechanical properties for other parts of the body. As a pilot study, we have already explored the electrical and optical properties of ventricular myocardial tissues obtained from endomyocardial biopsy specimens from patients suffering/who suffered from myocardial fibrosis (for diseased tissue samples) and cadavers (for healthy myocardium samples), using NIR-based linear polarization system and, electrical impedance measurement with fabricated microchip. Our preliminary results using these modalities are encouraging. Hence, we would like to explore the mechanics of fibrosis of heart tissues for predicting cardiovascular condition. This helps us to develop an intraoperative minimally invasive probe for characterizing the heart tissues in-vivo. |