Evaluation of the Normal Distribution of Rubidium-82(Rb-82), Nitrogen-13 (N-13)Ammonia, and Fluorine-18 Fluorodeoxyglucose (F-18FDG) in Normal Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- analysis of healthy cardiac distribution of Rb-82, N-13 ammonia, and F-18 FDG.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy normal volunteers
排除标准
- •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)
- •Inability to lay flat with your arms positioned next to your head for approximately 20 minutes.
- •Morbid Obesity
- •Breasts Implants
- •Use of anabolic steroids
- •Use of recreational drugs
研究组 & 干预措施
Rb-82 and N-13 ammonia Pet scans
Rest and vasodilator stress Rb-82 images and N-13 ammonia images will be taken according to standard clinical imaging protocol. Each of these two imaging studies require the injection of Rb-82 and N-13 ammonia by intravenous administration (IV) in the patient's arm.
干预措施: Rb-82 Pet scans (Other)
Rb-82 and N-13 ammonia Pet scans
Rest and vasodilator stress Rb-82 images and N-13 ammonia images will be taken according to standard clinical imaging protocol. Each of these two imaging studies require the injection of Rb-82 and N-13 ammonia by intravenous administration (IV) in the patient's arm.
干预措施: N-13 ammonia Pet scans (Other)
Rb-82 and N-13 ammonia Pet scans
Rest and vasodilator stress Rb-82 images and N-13 ammonia images will be taken according to standard clinical imaging protocol. Each of these two imaging studies require the injection of Rb-82 and N-13 ammonia by intravenous administration (IV) in the patient's arm.
干预措施: Regadenoson (Drug)
F-18 FDG Imaging and Rb-82
Volunteers not excluded by abnormal rest/stress imaging with Rb-82, will begin F-18 FDG protocol.
干预措施: Rb-82 Pet scans (Other)
F-18 FDG Imaging and Rb-82
Volunteers not excluded by abnormal rest/stress imaging with Rb-82, will begin F-18 FDG protocol.
干预措施: F-18 FDG Pet scans (Other)
F-18 FDG Imaging and Rb-82
Volunteers not excluded by abnormal rest/stress imaging with Rb-82, will begin F-18 FDG protocol.
干预措施: Regadenoson (Drug)
F-18 FDG Imaging and N-13 ammonia
Volunteers not excluded by abnormal rest/stress imaging with N-13 ammonia, will begin F-18 FDG protocol.
干预措施: F-18 FDG Pet scans (Other)
F-18 FDG Imaging and N-13 ammonia
Volunteers not excluded by abnormal rest/stress imaging with N-13 ammonia, will begin F-18 FDG protocol.
干预措施: N-13 ammonia Pet scans (Other)
F-18 FDG Imaging and N-13 ammonia
Volunteers not excluded by abnormal rest/stress imaging with N-13 ammonia, will begin F-18 FDG protocol.
干预措施: Regadenoson (Drug)
结局指标
主要结局
analysis of healthy cardiac distribution of Rb-82, N-13 ammonia, and F-18 FDG.
时间窗: approximately 4 to 10 hours
Normal healthy volunteers will undergo PET imaging during vasodilator pharmacologic stress with regadenoson and at rest with Rb-82 and or N-13 ammonia and or at rest with F-18FDG. Participants will have either rest and stress Rb-82 and rest and stress N-13 ammonia or one of these stress tests and F-18 FDG imaging.
次要结局
未报告次要终点
研究者
James R. Corbett, M.D.
Principal Investigator
University of Michigan