Overview

This trial is active, not recruiting.

Conditions kidney transplantation, pancreas transplantation
Treatment dobutamine stress echocardiogram
Sponsor University of Nebraska
Start date April 2003
End date March 2012
Trial size 150 participants
Trial identifier NCT00580437, 142-03-FB

Summary

Examine the clinical utility of the dobutamine stress contrast echoes and angiograms obtained routinely in the evaluation of patients prior to kidney or pancreas transplantation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
stress echocardiograms involving the use of intravenous Optison or Definity contrast agents to improve endocardial definition
dobutamine stress echocardiogram Definity
stress echocardiograms involving the use of intravenous Optison or Definity contrast agents to improve endocardial definition

Primary Outcomes

Measure
Provide a higher sensitivity required to adequately assess risks in the pancreas/ kidney transplant evaluation
time frame: I year

Secondary Outcomes

Measure
Eliminate the need for costly and invasive additional procedures
time frame: 1 year

Eligibility Criteria

Male or female participants at least 19 years old.

Inclusion Criteria: - Patients who are being evaluated for a kidney and or pancreas transplant and scheduled for a dobutamine stress echocardiogram and a coronary angiogram will be eligible to participate Exclusion Criteria: - Patients with unstable angina at the time of their evaluation, or who have a severe underlying cardiomyopathy or valve disease will be excluded.

Additional Information

Official title The Analysis of Data Collected During Angiography and Dobutamine Stress Contrast Echocardiograms in the Pre-Evaluation of Kidney and Pancreas Transplant Patients
Principal investigator Thomas R Porter, MD
Description Although there is an increasing quantity of data demonstrating the value of stress echo in risk stratifying patients for cardiac risk prior to major non-cardiac surgery, the current clinical practice utilized for assessing patients being evaluated for kidney or pancreas transplantation is both a stress echocardiogram and a coronary angiogram. This gap in opinion appears to be a concern on the part of both nephrologists, endocrinologists, and surgeons that the stress echocardiogram may miss significant angiographic disease that could result in major post-operative complications in this high-risk subgroup of patients (unstable angina, non-fatal infarction, or death).
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by University of Nebraska.