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Safety and dosimetry of CardioPETâ„¢ will be evaluated in normal healthy volunteers and CAD subjects both male and female between the ages of 50-85. Nine normal controls will undergo repeated whole body imaging for biodistribution and dosimetry estimation. Six other normal healthy subjects will undergo heart imaging only. Six CAD subjects will undergo heart imaging only.
CardioPETâ„¢ is a modified fatty acid (MFA) that closely resembles naturally-occurring free fatty acids (FFAs) in the human body.
Study Procedures:
Visit 1: Screening - Eligibility determination
Visit 2: Injection and PET Imaging
Visit 3: Follow-up Visit
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CardioPET | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioPET | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in vital signs. Change in physical examination. Change in ECG. Change in 24-hour Holter. Change in dosimetry (blood and urine)measured at time 0 (immediately folloing injection), 1, 5, 15, 30, 60, and 90 minutes. Adverse event assessment. | Normal healthy volunteers for whole body imaging group and NHV and Coronary Artery Disease (CAD)undergoing cardiac imaging. | Screening, Pre-dose, Baseline, Day 1, Pre-, Post-Dose 0, 24-48 hours and 7 days (Adverse events). |
| Measure | Description | Time Frame |
|---|---|---|
| Performance characteristics of CardioPET as a PET tracer for myocardial imaging. | Normal healthy volunteers and CAD subjects for Cardiac Imaging Only. | 0, 1 min, 5 min, 15 min, 30 min, 60 min, and 90 min. |
| Evaluation and optimization of the methods of image acquisition, output processing, display, reconstruction, and imaging data |
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Inclusion Criteria:
Normal Healthy Volunteers:
Coronary Artery Disease (CAD) subjects:
Exclusion Criteria:
Normal Healthy Volunteers:
Coronary Artery Disease (CAD) Subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Alan J. Fischman, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Baseline, 15 second time frames for first 2 minutes, 1 min. time frame for next 8 min., 2 min frames for remainder of 60 min study. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |