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Completed

NCT Number: NCT00580437

Pre-operative Evaluation of Kidney & Pancreas Transplant Patients

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.

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Key information

Conditions

Kidney Transplantation Pancreas Transplantation

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dobutamine Stress Echocardiogram

Procedure

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

Other names: Definity, Optison

Primary outcomes

  1. Stress echocardiogram diagnostic sensitivity

    Time frame: prior to transplantation

    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.

  2. Event-free survival

    Time frame: 3 years

    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.

Secondary outcomes

  1. Abnormal stress myocardial perfusion rate

    Time frame: 3 years

    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.

  2. Abnormal stress wall motion rate

    Time frame: 3 years

    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.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

The Analysis of Data Collected During Angiography and Dobutamine Stress Contrast Echocardiograms in the Pre-Evaluation of Kidney and Pancreas Transplant Patients

Important dates

Study start
2003
Primary completion
2012
Study completion
2012
First posted
Dec 24, 2007
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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