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Trial registered on ANZCTR


Registration number
ACTRN12611000783921
Ethics application status
Approved
Date submitted
25/07/2011
Date registered
27/07/2011
Date last updated
15/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cardiovascular Magnetic Resonance Imaging study assessing myocardial ischemia in patients with end-stage renal disease and renal transplant - post renal transplant cohort
Scientific title
Study of myocardial ischemia post renal transplant as assessed by Cardiac MRI in patients with end-stage renal disease
Secondary ID [1] 262373 0
None
Universal Trial Number (UTN)
U1111-1122-1549
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Ischaemia in patients with renal disease 268078 0
Condition category
Condition code
Cardiovascular 268225 268225 0 0
Coronary heart disease
Renal and Urogenital 268226 268226 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Framingham's risk score at baseline (race, age, smoking history, family history of cardiac disease, cardiac risk factors)
Blood tests at baseline - biochemical markers (hsCRP); markers of fibrosis (MMP); troponin T, BNP and homocysteine levels.
Cardiac MRI at baseline - cine images; Blood oxygen level dependent MRI (BOLD) rest and stress using adenosine 140mcg/kg/min for 3-6 minutes; 1st pass perfusion imaging after rapid bolus Gd-DTPA 0.045 mmol/kg body weight, then after 15 minutes a further 0.045 mmol/kg Gd-DTPA would be given to obtain resting perfusion; finally delayed enhancement CMR.
Follow up via phone call at 6, 12 and 24 months for Major Adverse Cardiac Events - including angina, myocardial infarction, rehospitalisation with cardiac event, cerebrovascular event, heart failure and death.
Intervention code [1] 267041 0
Early detection / Screening
Intervention code [2] 267051 0
Diagnosis / Prognosis
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269284 0
Major Adverse Cardiac Events including angina, myocardial infarction, rehospitalisation with cardiac event, cerebrovascular event, heart failure and death assessed by reviewing patients medical records and phone call
Timepoint [1] 269284 0
6, 12 and 24 months
Secondary outcome [1] 279296 0
BOLD, Delayed Enhancement-CMR and first pass perfusion as predictors of Major Adverse Cardiac Events
Timepoint [1] 279296 0
6, 12 and 24 months
Secondary outcome [2] 279320 0
Troponin T and hsCRP as predictors of Major Adverse Cardiac Events
Timepoint [2] 279320 0
6, 12 and 24 months

Eligibility
Key inclusion criteria
all patients who have undergone renal transplant >3 months ago; eGFR >45mls/min
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
inability to give informed consent; extreme claustrophobia; implantable cardiac devices and other contra-indications to MRI; asthma or other reversible bronchospasm; patients on theophylline; inability to lie flat for 1hr; eGFR <45mls/min;

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267512 0
Hospital
Name [1] 267512 0
Flinders Medical Centre
Country [1] 267512 0
Australia
Primary sponsor type
Individual
Name
Professor Joseph Selvanayagam
Address
Dept Cardiovascular Medicine
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK
SA 5042
Country
Australia
Secondary sponsor category [1] 266554 0
None
Name [1] 266554 0
Address [1] 266554 0
Country [1] 266554 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269479 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 269479 0
Ethics committee country [1] 269479 0
Australia
Date submitted for ethics approval [1] 269479 0
09/09/2010
Approval date [1] 269479 0
14/02/2011
Ethics approval number [1] 269479 0
1/10/0380

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32744 0
Address 32744 0
Country 32744 0
Phone 32744 0
Fax 32744 0
Email 32744 0
Contact person for public queries
Name 15991 0
Christine Edwards
Address 15991 0
Flinders Clinical Research
Level 3A
Mark Oliphant Building
Laffer Drive
BEDFORD PARK
SA 5042
Country 15991 0
Australia
Phone 15991 0
+61 8 8201 5656
Fax 15991 0
Email 15991 0
[email protected]
Contact person for scientific queries
Name 6919 0
Professor Joseph Selvanayagam
Address 6919 0
Dept Cardiovascular Medicine
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK
SA 5042
Country 6919 0
Australia
Phone 6919 0
+61 8 8404 3971
Fax 6919 0
Email 6919 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.