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



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:30 - 70
Updated:2/1/2019
Start Date:November 2011
End Date:January 19, 2018

Use our guide to learn which trials are right for you!

Evaluation of the Normal Distribution of Rubidium-82(Rb-82), Nitrogen-13 (N-13)Ammonia, and Fluorine-18 Fluorodeoxyglucose (F-18FDG) in Normal Volunteers

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.

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 evaluating 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 types of imaging, such as SPECT perfusion imaging and
echocardiography.

These studies help physicians plan potentially life saving procedures to re-establish
coronary blood flow to living but severely 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.

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
We found this trial at
1
site
Ann Arbor, Michigan 48109
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials