Distribution of Rubidium-82, Nitrogen-13 Ammonia, and Florine-18 Fluorodeoxyglucose in Normal Volunteers
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| First Received Date ICMJE | September 13, 2011 | ||||||||
| Last Updated Date | January 14, 2013 | ||||||||
| Start Date ICMJE | August 2011 | ||||||||
| Estimated Primary Completion Date | August 2016 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
analysis of healthy cardiac distribution of Rb-82, N-13 ammonia, and F-18 FDG. [ Time Frame: approximately 4 to 10 hours ] [ Designated as safety issue: Yes ] Normal healthy volunteers will undergo PET imaging during vasodilator pharmacologic stress with regadenoson and at rest with Rb-82 or N-13 ammonia and at rest with F-18FDG. |
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| Original Primary Outcome Measures ICMJE |
analysis of healthy cardiac distribution of Rb-82, N-13 ammonia, and F-18 FDG. [ Time Frame: approximately 4 hours ] [ Designated as safety issue: Yes ] Normal healthy volunteers will undergo PET imaging during vasodilator pharmacologic stress with regadenoson and at rest with Rb-82 or N-13 ammonia and at rest with F-18FDG. |
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| Change History | Complete list of historical versions of study NCT01433705 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Distribution of Rubidium-82, Nitrogen-13 Ammonia, and Florine-18 Fluorodeoxyglucose in Normal Volunteers | ||||||||
| Official Title ICMJE | Evaluation of the Normal Distribution of RubiniumRubidium-82(Rb-82), Nitrogen-13 (N-13)Ammonia, and Florine-18 Fluorodeoxyglucose (F-18FDG)in Normal Volunteers | ||||||||
| Brief Summary | Establish the normal distributions of Rb-82, N-13 ammonia, and F-18 FDG in the heart using PET imaging for subsequent use in the evaluation of U of M clinical patient studies using these procedures. Normal healthy volunteers will be extensively screened for this study. Subjects will be given IV administration of Rb-82 and N-13 to acquire rest/stress imaging. Patients not excluded by any abnormality during the Rb-82 and N-13 rest/stress studies will be given 100 grams of dextrose orally and when glucose levels are below 120mg/dl, the F-18 FDG imaging will be administered IV per protocol. |
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| Detailed Description | Cardiac rubidium-82(Rb-82)and N-13 ammonia heart perfusion (blood flow) studies and florine-18 fluorodeoxyglucose (F-18FDG)heart PET glucose metabolism studies are important tools for the evaluation of patients with coronary heart disease. This includes patients with known or suspected heart disease and patients with congestive heart failure following myocardial infarction (heart attack)with indeterminant assessments of cardiac health from other imaging modalities, for example SPECT perfusion imaging and echocardiography. These studies help physicians plan potentially life saving procedures to re-establish coronary blood flow to living but severly compromised heart muscle. Rb-82 and N-13 ammonia studies can tell if there is reduced blood flow to the heart muscle either at rest or during stress. FDG studies can tell whether there is any chance of a beneficial effect from coronary revascularization procedures, for example coronary angioplasties and stents or coronary artery bypass. Revascularization procedures in patients like these may be technically difficult, risky and costly. Unfortunately the normal cardiac distributions of Rb-82, N-13 and ammonia, and F-18FDG for computer analysis of human studies are not well known and what is known is not widely available for clinical use. The latest imaging guidelines from the American Society of Nuclear Cardiology recommend that Rb-82, N-13 ammonia, and FDG cardiac studies be compared to normal distributions or patterns of these radiotracers in the heart developed from a series of normal individuals. The purpose for these studies is to generate databases of normal Rb-82, N-13 ammonia, and F-18FDG cardiac distributions so that they can be used in the analysis of clinical patient studies at the University of Michigan Hospital. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE | Heart Disease | ||||||||
| Intervention ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 145 | ||||||||
| Estimated Completion Date | August 2016 | ||||||||
| Estimated Primary Completion Date | August 2016 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 30 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01433705 | ||||||||
| Other Study ID Numbers ICMJE | HUM00016183 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | James R. Corbett, M.D., University of Michigan | ||||||||
| Study Sponsor ICMJE | University of Michigan | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Michigan | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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