11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension
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|ClinicalTrials.gov Identifier: NCT01917136|
Recruitment Status : Completed
First Posted : August 6, 2013
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension||Drug: 11C-acetate Drug: [18F]Fluoro-2-deoxy-2-D-glucose Other: Cardiac MRI||Phase 2|
We will measure right ventricular metabolic and structural changes using serial 11C-acetate and 18F-FDG PET/CT and cardiac MRI as response to treatment with ranolazine. Subjects undergo imaging procedures at week 0 and week 26 (optional for normal function patients). This is a companion imaging trial for patients who are eligible for the treatment trial entitled "A randomized, double-blind, placebo controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative study of cellular metabolism in subjects with pulmonary hypertension with and without right ventricular dysfunction". Subjects must enroll in companion treatment protocol to qualify for the imaging protocol.
The cardiac MRI portion of the study continued, but the PET portion of the study was discontinued due to funding.
The treatment protocol is registered under: NCT01839110. Due to funding issues, the completed study was registered under NCT02829034.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Regional Myocardial Perfusion, Glucose Utilization and Oxidative Metabolism in Patients With Pulmonary Hypertension Using Combined [11C]Acetate and [18F]Fluorodeoxyglucose (FDG) PET/CT and Cardiovascular MRI|
|Actual Study Start Date :||August 2013|
|Actual Primary Completion Date :||October 2018|
|Actual Study Completion Date :||October 2018|
Experimental: 11c-acetate and 18F-FDG, and cardiac MRI
For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate and a 10 millicurie injection of 18F-FDG At baseline/6 months follow up, a cardiac MRI will be performed.
For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate
For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG
Other Name: 18F-FDG
Other: Cardiac MRI
Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.
- Changes in RV Function [ Time Frame: 6 months ]RV function as measured by cardiac MRI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917136
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Yuchi Han, MD||University of Pennsylvania|