RecruitingACTRN12611000783921

Cardiovascular Magnetic Resonance Imaging study assessing myocardial ischemia in patients with end-stage renal disease and renal transplant - post renal transplant cohort

Study of myocardial ischemia post renal transplant as assessed by Cardiac MRI in patients with end-stage renal disease


Sponsor

Professor Joseph Selvanayagam

Enrollment

80 participants

Start Date

Jul 7, 2011

Study Type

Interventional

Conditions

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


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is using a special type of heart MRI scan to check whether people who have had a kidney transplant have poor blood flow to their heart muscle (called myocardial ischemia). People with kidney disease have a much higher risk of heart problems, and this study tests a new MRI technique that can detect problems even before symptoms appear. This is the group of patients who received a kidney transplant more than 3 months ago. You may be eligible if: - You are 18 years or older - You received a kidney transplant more than 3 months ago - Your kidney function (eGFR) is above 45 mL/min You may NOT be eligible if: - You cannot give informed consent - You have severe claustrophobia (fear of enclosed spaces) - You have a pacemaker or other metal implant that cannot go in an MRI - You have asthma or reactive airways - You take theophylline medication - You cannot lie flat for 1 hour - Your kidney function (eGFR) is below 45 mL/min Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 (

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.


Locations(1)

Australia

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ACTRN12611000783921