Pre-operative Evaluation of Kidney & Pancreas Transplant Patients

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580437
• Other study ID #: 0142-03-EP
• Status: Completed
• Phase: N/A
• Start date: May 2, 2003
• Est. completion date: April 1, 2012

Study information

• Verified date: February 2024
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 1, 2012
• Est. primary completion date: March 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplantation
• Pancreas Transplantation

Intervention

Procedure:
• Dobutamine Stress Echocardiogram
stress echocardiograms involving the use of intravenous Optison or Definity contrast agents to improve endocardial definition

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	prior to transplantation
Primary	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.	3 years
Secondary	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.	3 years
Secondary	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.	3 years