| CTRI Number |
CTRI/2025/09/094174 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Echocardiography for predicting heart dysfunction |
|
Scientific Title of Study
|
Right atrial strain in predicting right ventricular-pulmonary artery uncoupling in adult valvular heart disease patients with pulmonary artery hypertension undergoing cardiac surgery: 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 |
Satyajeet Misra |
| Designation |
Professor and HOD |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Dept of Anaesthesia and Critical Care,
All India Institute of Medical Sciences, Bhubaneswar
Sijua, Patrapada, Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Satyajeet Misra |
| Designation |
Professor and HOD |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Dept of Anaesthesia and Critical Care,
All India Institute of Medical Sciences, Bhubaneswar
Sijua, Patrapada, Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Satyajeet Misra |
| Designation |
Professor and HOD |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Dept of Anaesthesia and Critical Care,
All India Institute of Medical Sciences, Bhubaneswar
Sijua, Patrapada, Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Khorda, Orissa, 751019 |
|
|
Primary Sponsor
|
| Name |
Satyajeet Misra |
| Address |
Room no-409, Academic block,
All India Institute of Medical Sciences Sijua, Patrapada, Bhubaneswar, Orissa, India, 751019 |
| Type of Sponsor |
Other [Individual] |
|
|
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 |
| Deepak Borde |
Ozone Hospitals, Aurangabad |
Department of Cardiac Anesthesia, Ozone Hospitals, Aurangabad Aurangabad MAHARASHTRA |
7350357108
deepakborde2482@gmail.com |
| Dr Satyajeet Misra |
All India Institute of Medical Sciences Bhubaneswar |
Sijua, Patrapada, Bhubaneswar, Orissa Khordha ORISSA |
9438884048
misrasatyajeet@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee |
Approved |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I061||Rheumatic aortic insufficiency, (2) ICD-10 Condition: I060||Rheumatic aortic stenosis, (3) ICD-10 Condition: I051||Rheumatic mitral insufficiency, (4) ICD-10 Condition: I050||Rheumatic mitral stenosis, (5) ICD-10 Condition: I052||Rheumatic mitral stenosis with insufficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults with left sided heart disease and pulmonary artery hypertension will be included in this study. |
|
| ExclusionCriteria |
| Details |
Adults with insufficient images will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the correlation of peak RA strain with TAPSE/PASP that predicts RV-PA uncoupling in patients with PAH. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Differences in peak RA strain values between coupled & uncoupled RVs |
Baseline |
| Cutoff values of peak RA strain that predicts RV-PA uncoupling. |
Baseline |
| Correlation of peak RA strain with other echocardiographic measures of uncoupled RVs |
Baseline |
| Correlation of conduit & contractile strain values with TAPSE/PASP in uncoupled ventricles. |
Baseline |
| Changes in RA EF in RV-PA uncoupling. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
15/09/2025 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Right ventricular–pulmonary artery (RV-PA) coupling refers to the interplay between RV contractility and RV afterload. Normal RV-PA coupling is maintained only when the RV function and RV afterload, i.e., the pulmonary vascular resistance are appropriately matched. A normal RV-PA coupling leads to a more efficient energy transfer between the RV and PA, and optimizes myocardial work. RV-PA uncoupling occurs when RV contractility cannot increase to match increased RV afterload as in patients with pulmonary artery hypertension (PAH), resulting in RV dysfunction and failure. Identifying uncoupled RVs in patients with PAH may help determine which patients are at a greater risk of RV failure following cardiac surgery; thus, potentially serving as a risk-stratification marker. RV-PA coupling is computed as the ratio of RV end-systolic elastance (contractility index) to PA elastance (arterial load index), measured invasively with right heart catheterization. Though it has high sensitivity and accuracy, it is technically difficult to perform and has limited bedside applicability. RV-PA coupling can be also assessed non-invasively with echocardiography. Amongst the various non-invasive surrogates for RV-PA coupling, the tricuspid annular plane systolic excursion (TAPSE)/pulmonary artery systolic pressure (PASP) ratio has emerged as the best parameter that identifies uncoupled RVs. A cutoff value of TAPSE/PASP of < 0.36 mm/mm Hg predicts RV-PA uncoupling in patients with left heart disease. RA strain is a novel parameter that provides a measure of RV function. It includes reservoir strain (peak RA strain), which indicates atrial compliance during ventricular systole; and conduit and pump (contractile) strain during ventricular diastole. It can easily be obtained by the apical 4-chamber view and is an angle as well as load independent parameter. Though RA strain has been used to predict RV dysfunction in patients with type I PAH, cardiomyopathies, atrial arrhythmias etc., its usefulness in predicting RV-PA uncoupling is yet unexplored in adult valvular heart disease patients with PAH undergoing cardiac surgery. We hypothesize that preoperative RA strain can be used to predict RV-PA uncoupling following cardiac surgery. |