Pre-operative Evaluation of Kidney & Pancreas Transplant Patients

University of Nebraska150 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

150

Conditions

Kidney Transplantation Pancreas Transplantation

Interventions

Dobutamine Stress EchocardiogramPROCEDURE

stress echocardiograms involving the use of intravenous Optison or Definity contrast agents to improve endocardial definition

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Nebraska Medical Center

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

Stress echocardiogram diagnostic sensitivity

Prior to the pancreas or kidney transplant, wall motion by stress echocardiograms indicates the cardiac risk. Intravenous administered Optison or Definity contrast agents during the stress echo improve endocardial definition, enabling better assessment of myocardial perfusion and significant angiographic disease. This is particularly crucial in the high-risk subgroup of patients (unstable angina, non-fatal infarction, or death) to identify potential major post-operative complications.

Time frame: prior to transplantation

Event-free survival

Patients were followed up for the primary outcome variable, event-free survival (EFS), defined as the time from transplant to the incidence of myocardial infarction, heart failure hospitalization, or all-cause mortality. Analyze EFS in pancreas or kidney transplant patients.

Time frame: 3 years

Secondary Outcomes

Abnormal stress myocardial perfusion rate

Analyze myocardial perfusion simultaneously during the replenishment phase of contrast following high mechanical index impulses using a 17-segment model. Any abnormal perfusion response had to be confirmed by a second independent expert reviewer, blinded to angiographic or clinical outcome data. Fixed or inducible segments were considered abnormal. Calculate the abnormal stress myocardial perfusion rate in the transplant patients and analyze the association with the risk of an event after transplantation.

Time frame: 3 years

Abnormal stress wall motion rate

Analyze wall motion simultaneously during the replenishment phase of contrast following high mechanical index impulses using a 17-segment model. Any abnormal wall motion response had to be confirmed by a second independent expert reviewer, blinded to angiographic or clinical outcome data. Fixed or inducible segments were considered abnormal. Calculate the abnormal stress wall motion rate in the transplant patients and analyze the association with the risk of an event after transplantation.

Data from ClinicalTrials.gov

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