| Trial ID: | L1312 |
| Source ID: | NCT00782639
|
| Associated Drug: |
Iopamidol Injection 76%
|
| Title: |
Renal Safety of Iopamidol Versus Iodixanol During Coronary Angiography in Diabetic Patients
|
| Acronym: |
RECARE
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00782639/results
|
| Conditions: |
Chronic Renal Impairment|Diabetes Mellitus
|
| Interventions: |
DRUG: Iopamidol injection 76%|DRUG: iodixanol
|
| Outcome Measures: |
Primary: The Number of Participants With Contrast-induced Nephropathy (CIN), The number of participants who presented with CIN (defined as an increase in Serum Creatinine (SCr) from baseline greater than or equal to 0.5 mg/dL following the administration of iopamidol-370 or iodixanol 320 while undergoing cardiac angiography). Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event., 48 to 72 hours After Injection of Contrast Media|Baseline and Change From Baseline Measurements for the One Participant With Contrast-Induced Nephropathy (CIN) at the 48 to 72 Hours After Injection of Contrast Media Visit, Only 1 participant presented with incidence of CIN (change from baseline greater than or equal to 0.5 mg/dL) following the administration of iopamidol-370 while undergoing cardiac angiography. The participant's measurements at baseline and at 48 to 72 hours after the injection of contrast agent, as well as the difference between the two, are displayed here. Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event., Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media | Secondary: The Number of Participants With a >=25% Decrease in Estimated Glomerular Filtration Rate (eGFR), This outcome measure provides the total number of participants that had a decrease from baseline in eGFR greater or equal to 25% within 48 to 72 hours following the cardiac angiography procedure., Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media|The Number of Participants With a >=25% Increase in Serum Creatinine (SCr), This outcome measure provides the total number of participants that had a increase from baseline in SCr greater or equal to 25% within 48 to 72 hours following the cardiac angiography procedure., Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media|Number of Participants Requiring Dialysis, This outcome measure provides the total number of participants requiring dialysis occurring from acute renal failure., 48 to 72 hours after injection of contrast media|Number of Participants Who Died From Acute Renal Failure, This outcome measure provides the total number of participants who died as a result of acute renal failure., Any timepoint (Screening [up to 72 hours prior to injection of contrast media], Baseline [just before injection], or 48 to 72 hours or 7 days after injection)
|
| Sponsor/Collaborators: |
Sponsor: Bracco Diagnostics, Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
23
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: DIAGNOSTIC
|
| Start Date: |
2009-03
|
| Completion Date: |
2009-09
|
| Results First Posted: |
2011-09-01
|
| Last Update Posted: |
2012-01-26
|
| Locations: |
Bracco Diagnostics Inc., Princeton, New Jersey, 08540, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00782639
|
