Distribution of Rubidium-82, Nitrogen-13 Ammonia, and Fluorine-18 Fluorodeoxyglucose in Normal Volunteers
Completed · Phase 1
Conditions studied: Heart Disease
In brief
Establish the normal distributions of Rb-82, N-13 ammonia, and F-18 FDG (radioactive tracers) in the heart using PET imaging. These tracers would be eventually used in evaluating the hearts of patients with heart disease. Normal healthy volunteers will be carefully screened for this study. Subjects will be given IV administration of Rb-82 and N-13 to acquire rest/stress imaging. Normal subjects not excluded by any unexpected abnormality during the Rb-82 or N-13 rest/stress studies will undergo a glucose loading F-18 FDG imaging protocol, viability protocol using the hyperinsulinemic euglycemic clamp with simultaneous IV infusions of dextrose and insulin according to standard procedures in our laboratory. These same subjects will have a F-18 FDG protocol after following a high fat, protein permitted, no carbohydrate diet for approximately 30 hours prior to F-18 FDG injection. The F-18 FDG radiotracer will be given through an IV.
Key facts
- Study ID
- NCT01433705
- Run by
- University of Michigan
- People needed
- 70
- Starts
- 2011-11-01
- Expected to finish
- 2018-01-19
- Last updated by the study team
- 2019-01-30
Who can join
Age: 30 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy normal volunteers
You may not qualify if…
- Prior participation in a study with significant radiation exposure
- Significant radiation exposure for other reasons, example: routine medical care
- Medical history of physical or treadmill exercise stress EKG evidence of heart or vascular disease.
- Cardiac A-V conduction abnormalities
- Diabetes Mellitus
- Liver Disease
- Kidney Disease
- Other chronic debilitating illnesses ( Example: Rheumatoid Arthritis, Emphysema, Parkinson's Disease).
- Tobacco use, hypertension, diabetes, family history of coronary artery disease before age 45 in males and 55 in females or other coronary risks factors of more than mild severity
- Claustrophobia (fear of tight spaces)
- Pregnancy
- Inability to lay flat with your arms positioned next to your head for approximately 20 minutes.
- Morbid Obesity
- Asthma
- Breasts Implants
- Use of anabolic steroids
- Use of recreational drugs
Where it is running
- University of Michigan Hospital — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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