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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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Rheumatic heart disease with established mitral valve disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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