| CTRI Number |
CTRI/2018/08/015149 [Registered on: 01/08/2018] Trial Registered Prospectively |
| Last Modified On: |
31/07/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Cardiac MRI in Rheumatic heart disease |
|
Scientific Title of Study
|
MRI to Aid Surgical Timing Decision in Rheumatic Heart Disease |
| Trial Acronym |
MASTD-RHD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varsha Kiron |
| Designation |
Assistant Professor |
| Affiliation |
Christian Medical College and Hospital, Vellore |
| Address |
Department of Cardiology
Christian Medical College and Hospital,
Vellore, India.632004
Vellore TAMIL NADU 632004 India |
| Phone |
04162282698 |
| Fax |
|
| Email |
kironvarsha@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Varsha Kiron |
| Designation |
Assistant Professor |
| Affiliation |
Christian Medical College and Hospital, Vellore |
| Address |
Department of Cardiology
Christian Medical College and Hospital,
Vellore, India.632004
Vellore TAMIL NADU 632004 India |
| Phone |
04162282698 |
| Fax |
|
| Email |
kironvarsha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Varsha Kiron |
| Designation |
Assistant Professor |
| Affiliation |
Christian Medical College and Hospital, Vellore |
| Address |
Department of Cardiology
Christian Medical College and Hospital,
Vellore, India.632004
Vellore TAMIL NADU 632004 India |
| Phone |
04162282698 |
| Fax |
|
| Email |
kironvarsha@gmail.com |
|
|
Source of Monetary or Material Support
|
| University of South Australia |
|
|
Primary Sponsor
|
| Name |
University of South Australia |
| Address |
Dr Ross McLennan
Director: Research and Innovation Services
GPO Box 2471 Adelaide SA 5001
08 8302 5797
grant.management@unisa.edu.au
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Christian Medical College and Hospital |
Christian Medical College and Hospital, Vellore, India. 642004 |
|
|
Countries of Recruitment
|
Australia India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Varsha Kiron |
Christian Medical College and Hospital |
Department of Cardiology
Christian Medical College and Hospital,
Ida Scudder Road Vellore TAMIL NADU |
9894365503
kironvarsha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD, CHRISTIAN MEDICAL COLLEGE, VELLORE. REG NO.ECR/326/INST/TN/23/2013 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Rheumatic heart disease with established mitral valve disease, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Asymtpomatic moderate or severe MS (MVA<1.5cm2 or mean PG >5mmHg)
2. Asymptomatic moderate-severe mixed mitral valve disease (mean PG>5).
3. Asymptomatic moderate or severe MR. |
|
| ExclusionCriteria |
| Details |
1. Moderate or severe aortic regurgitation as this affects LV dilation that occurs due to mitral regurgitation.
2. Any other severe valvular lesion as this would confound the data (tricuspid, pulmonary and aortic lesions that are moderate in severity are acceptable excluding moderate aortic regurgitation).
3. Significant ischaemic heart disease (previous MI or known coronary stenosis >70%) as this would affect the stress test and scar results.
4. LV ejection fraction < 60% or LV end-diastolic diameter (LVEDD) >44mm.
5. Participant must not be part of another active trial.
6. Participant must not be pregnant or lactating.
7. Other severe comorbid condition, concurrent medication, or other issue that renders the participant unsuitable for participation in the study (e.g. exercise limiting lung disease).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in exercise treadmill test time
2. Class I indications for surgery/intervention
3. New atrial fibrillation
4. Stroke (or transient ischaemic attack (TIA) with CT or MRI evidence of an event)
5. Surgery or valvuloplasty
6.Cardiac death (including stroke)
|
1.Change in exercise treadmill test time at six months
2. Class I indications for surgery/intervention in six months
3. New atrial fibrillation in six months
4.Stroke (or transient ischaemic attack in six months (TIA) with CT or MRI evidence of an event)
5. Surgery or valvuloplasty in six months
6. Cardiac death (including stroke)i six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Change in EQ-5D-5L Health Questionnaire score
- Change in pro-BNP
- Hospitalisations
• Including heart failure related admissions
- New subclinical atrial fibrillation
- Atrial fibrillation burden
|
Baseline, six months, twelve months and two years |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="45"
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 1 |
|
Date of First Enrollment (India)
|
16/08/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/08/2018 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The publication which comes out of the data collected will be published in peer reviewed journals for the advancement of science. The veracity of the data will be the collective responsibility of both the prinicipal investigators and the co-investigators at the respective sites |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective, multi-centre observational study looking at baseline, one year, and two year changes in cardiac function compared to clinical outcomes in participants with rheumatic heart disease and examining whether CMR can predict outcomes better than echocardiography or exercise stress testing alone. This will aim to enrol 45 asymptomatic patients with RHD from CMC Vellore (15 severe MS, 15 moderate MMVD, 15 severe MR). The date of birth, body weight, height, gender, race and all medications will be collected. The medical history of the participant will also be recorded. Heart failure related hospitalisations, new symptoms, new atrial fibrillation and strokes will be recorded. Participants will complete the EQ-5D-5L Health Questionnaire at regular intervals. Blood will be drawn and processed to determine the creatinine, haemoglobin, haematocrit, CRP and BNP. A regular and comprehensive TTE with 3D is standard of care for every participant with mitral valve disease. LV strain, left atrial LA ejection fraction and LA systolic function requires no additional views to the standard echocardiogram for comprehensive mitral valve assessment. Images for these novel indices will be assessed offline using customized software. An exercise stress test for evaluation of symptoms and changes in pulmonary pressures will be performed yearly. The minimum target number of participants for each group in this study is 20. This is based upon power calculations showing that 16 patients would be needed to show a 10% reduction in exercise treadmill time with an α of 0.05 and 80% power. |