Trial Review

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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
1 Flinders Drive
BEDFORD PARK
SA 5042
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
This project is designed to assess myocardial ischemia in various populations of patients with renal disease. These cohorts of patients have significant cardiovascular morbidity and mortality. It is believed that apart from epicardial coronary disease, they also have microvascular or small vessel ischemia. Dialysis is thought to be a major contributor in acceleration of their cardiovascular disease, however even after renal transplantation, there cardiovascular morbidity and mortality does not mirror the general population. We are going to assess myocardial ischemia using cardiac MRI and blood oxygen level dependent imaging. This uses intrinsic contrast of deoxy-hemoglobin to assess ischemia. We are going to assess it in patients on dialysis regardless of their cardiovascular symptoms as this group of patients have significant disease despite lack of traditional cardiac symptoms. We are also going to look at patients being evaluated for renal transplant. In this population, we can directly compare this relatively new technique with traditional method of ischemia assessment. We believe this technique will provided added information to already existing imaging modalities as it looks at oxygenation of the myocardium, which precedes development of ischemia. Our third cohort, evaluates patients after their renal transplant, examining markers that may predict cardiovascular morbidity and mortality in this group. This trial is the post transplant cohort and is linked to trial ACTRN12611000786998 and ACTRN12611000785909
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.