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
NCT number | NCT00580437 |
Other study ID # | 0142-03-EP |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2, 2003 |
Est. completion date | April 1, 2012 |
Verified date | February 2024 |
Source | University of Nebraska |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska Medical Center | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska |
United States,
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 |
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