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Clinical Trial Details

Trial ID: L1708
Source ID: NCT03277183
Associated Drug: Low Dose Erythropoietin
Title: Frequent, Low-Dose Erythropoietin A Mechanistic Approach to Mitigate Adverse Cardiovascular Effects of Erythropoietin
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03277183/results
Conditions: Anemia|CKD|Atherosclerosis|Cardiovascular
Interventions: DRUG: Low dose erythropoietin|DRUG: High dose erythropoietin
Outcome Measures: Primary: Change in Carotid Total Plaque Volume From Baseline to Approximately 1 Year, as Assessed by Non-contrast MRI, The plaque characteristics will be analyzed by MRI-PlaqueViewTM (VP diagnostics Inc., WA). Planimetry will be performed on the image data sets, using histogram equalization to improve edge detection for plaque, arterial wall and lumen. Differences in image contrast between T1-weighted, T2-weighted, Time of Flight, and proton density will be used to characterize the plaque as fibrous, stable, or unstable., 1 year | Secondary: Severity of Maximal Stenosis at Baseline and Upon Follow-up., The plaque characteristics will be analyzed by MRI-PlaqueViewTM (VP diagnostics Inc., WA). Planimetry will be performed on the image data sets, using histogram equalization to improve edge detection for plaque, arterial wall and lumen. Differences in image contrast between T1-weighted, T2-weighted, Time of Flight, and proton density will be used to characterize the plaque as fibrous, stable, or unstable., 1 year|Percentage of Total Plaque Area at Baseline and Upon Follow-up., The plaque characteristics will be analyzed by MRI-PlaqueViewTM (VP diagnostics Inc., WA). Planimetry will be performed on the image data sets, using histogram equalization to improve edge detection for plaque, arterial wall and lumen. Differences in image contrast between T1-weighted, T2-weighted, Time of Flight, and proton density will be used to characterize the plaque as fibrous, stable, or unstable., 1 year|Characteristics of Plaques (Soft or Fibrous and Stable or Unstable) at Baseline and Upon Follow-up., The plaque characteristics will be analyzed by MRI-PlaqueViewTM (VP diagnostics Inc., WA). Planimetry will be performed on the image data sets, using histogram equalization to improve edge detection for plaque, arterial wall and lumen. Differences in image contrast between T1-weighted, T2-weighted, Time of Flight, and proton density will be used to characterize the plaque as fibrous, stable, or unstable., 1 year
Sponsor/Collaborators: Sponsor: VA Office of Research and Development
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 5
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2017-11-02
Completion Date: 2019-06-03
Results First Posted: 2020-08-13
Last Update Posted: 2020-08-13
Locations: North Florida/South Georgia Veterans Health System, Gainesville, FL, Gainesville, Florida, 32608, United States
URL: https://clinicaltrials.gov/show/NCT03277183