None listed
Conditions
Brief summary
Comparing safety outcomes of patients treated based on Cardiac MR/ imaging screening of acute rejection compared to endomyocardial biopsy guided screening. The imaging technniques used will be a combination of tissue characterisation, strain and ventricular function on CMR and TTE. Objectives: Primary Safety Outcomes Endpoints 1) Frequency and severity of cardiac rejection 2) Frequency and severity of serious infections 3) Cardiovascular morbidity 4) Cardiovascular hospitilisation 5) All cause for hospitilization 6) Death 7) Biopsy - related complications 8) Frequency and severity of cardiac allograft vasculopathy as determined by CTCA or Invasive angiography at 1 year 9) Total immunosuppression required 10) Measures of tissue characterisation and myocardial performance by CMR and TTE utilising in addition CMR strain and TTE global longitudinal strain
Interventions
Intervention Group- Cardiac MR based protocols will be used for screening for cardiac transplant allograft rejection as opposed to traditional endomyocardial biopsy
Consultant Cardiologist and Research Fellow Will be Supervising and Reporting the Cardiac MRI scans
Cardiac MRI protocol involved undergoing a cardiac MRI scan. This takes 30 minutes including the wait time.
Visits will be as per the biopsy clinic protocol
The screening protocols are part of the pre -existing protocol at St Vinc
Intervention Group- Cardiac MR based protocols will be used for screening for cardiac transplant allograft rejection as opposed to traditional endomyocardial biopsy Consultant Cardiologist and Research Fellow Will be Supervising and Reporting the Cardiac MRI scans Cardiac MRI protocol involved undergoing a cardiac MRI scan. This takes 30 minutes including the wait time. Visits will be as per the biopsy clinic protocol The screening protocols are part of the pre -existing protocol at St Vincent's Hospital and the fidelity to the intervention will have to be monitored by the reporting consultant cardiologist and the trial coordinator as the intervention group will only have CMR based protocols for screening for rejection. The same Cardiac MRI consultant will be reporting all the scans therefore there will be no inter-reporter variability Fortnightly for 3 months 3 monthly for the subsequent 3 months Monthly for the subsequent 3 months And 2 final scans at month 11 and 12 post transplant
Sponsors
Victor Chang Cardiac Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Stable Recipient of orthotopic heart transplant 4 weeks post transplant No contraindication to cardiac MRI
Exclusion criteria
Contraindication to cardiac MRI
Outcome results
None listed