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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000786998

Enrollment

Registered

2011-07-27

Start date

2011-07-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 study, evaluates patients after their renal transplant, examining markers that may predict cardiovascular morbidity and mortality in this group. This study is the evaluation for renal transplant cohort and is associated with ACTRN12611000783921 and ACTRN12611000785909

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 (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. These patients will then undergo dobutamine stress echocardiography (40 patients) or coronary angiography (40 patients) at the discretion of their cardiologist or renal physician as part of routine work up for transplant. Clinic visit at 12 months for repeat bloods. A subset of 50% of these patients who have been transplanted will have follow-up BOLD-MRI imaging performed 3 months after transplant, and delayed enhancement CMR imaging. Final phone follow up at 24 months.

Study design

Allocation

Non-randomised trial

Primary purpose

Diagnosis

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All patients placed on renal transplant waiting list and referred for cardiac assessment, regardless of their symptoms will be recruited in this study. 40 patients who have undergone DSE and 40 patients who have undergone coronary angiography

Exclusion criteria

Inability to give informed consent; Extreme Claustrophobia; Implantable cardiac devices and other contra-indications to MRI (i.e. metal in eyes); Asthma or other reversible bronchospasm; Patients on theophylline; Inability to lie flat for 1 hour

Outcome results