ANZCTR - Registration

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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]

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

Condition category

Condition code

Cardiovascular

Coronary heart disease

Renal and Urogenital

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]

Early detection / Screening

Intervention code [2]

Diagnosis / Prognosis

Comparator / control treatment

nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

6, 12 and 24 months

Secondary outcome [1]

BOLD, Delayed Enhancement-CMR and first pass perfusion as predictors of Major Adverse Cardiac Events

Timepoint [1]

6, 12 and 24 months

Secondary outcome [2]

Troponin T and hsCRP as predictors of Major Adverse Cardiac Events

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Flinders Medical Centre

Address [1]

1 Flinders Drive
BEDFORD PARK
SA 5042

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

1 Flinders Drive
BEDFORD PARK
SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/09/2010

Approval date [1]

14/02/2011

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Christine Edwards

Address

Flinders Clinical Research
Level 3A
Mark Oliphant Building
Laffer Drive
BEDFORD PARK
SA 5042

Country

Australia

Phone

+61 8 8201 5656

Fax

christine.edwards2@health.sa.gov.au

Contact person for scientific queries

Name

Professor Joseph Selvanayagam

Address

Dept Cardiovascular Medicine
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK
SA 5042

Country

Australia

Phone

+61 8 8404 3971

Fax

joseph.selva@health.sa.gov.au

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.

Trial Review

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