Distribution of Rubidium-82, Nitrogen-13 Ammonia, and Fluorine-18 Fluorodeoxyglucose in Normal Volunteers

• Status: Completed
• Trial end date: 2018-01-19
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Michigan
• Treatments: Regadenoson

Criteria

Inclusion Criteria:

• Healthy normal volunteers

Exclusion Criteria:

1. Prior participation in a study with significant radiation exposure

2. Significant radiation exposure for other reasons, example: routine medical care

3. Medical history of physical or treadmill exercise stress EKG evidence of heart or vascular disease.

4. Cardiac A-V conduction abnormalities

5. Diabetes Mellitus

6. Liver Disease

7. Kidney Disease

8. Other chronic debilitating illnesses ( Example: Rheumatoid Arthritis, Emphysema, Parkinson's Disease).

9. 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

10. Claustrophobia (fear of tight spaces)

11. Pregnancy

12. Inability to lay flat with your arms positioned next to your head for approximately 20 minutes.

13. Morbid Obesity

14. Asthma

15. Breasts Implants

16. Use of anabolic steroids

17. Use of recreational drugs