Pre-operative Evaluation of Kidney & Pancreas Transplant Patients

NCT00580437 | Completed DMC

• 1 other identifier: 0142-03-EP
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplantation; Pancreas Transplantation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Abnormal stress myocardial perfusion rate

  3 years

• Abnormal stress wall motion rate

  3 years

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Procedure: Dobutamine Stress Echocardiogram

Interventions

Dobutamine Stress Echocardiogram PROCEDURE

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

Also known as: Definity, Optison

Arm 1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with unstable angina at the time of their evaluation, or who have a severe underlying cardiomyopathy or valve disease will be excluded.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Interventions

perflutren; FS 069

Study Officials

• Thomas R Porter, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 24, 2007
• Study Start: May 2, 2003
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

US (1)