Cardiac Water and Fluoromethane Cardiac PET
This study has been completed.
Sponsor:
University of Wisconsin, Madison
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205127
First received: September 12, 2005
Last updated: August 28, 2012
Last verified: August 2012
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Purpose
In this study we are looking at the blood flow to the heart using two different chemical tags or tracers that give off a low level of radiation. The tracers used in this study are called O15-water and F17-fluoromethane. These tracers mix with the blood and will move through the body. The researchers will use positron emission tomography (PET scans)to track the tracers as they moe through the heart and chest.
| Condition | Intervention |
|---|---|
|
Healthy Volunteers |
Procedure: Cardiac PET imaging- rest and pharmacological stress |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Comparison of Cardiac Perfusion by O15-water and F17-fluoromethane PET |
Resource links provided by NLM:
Further study details as provided by University of Wisconsin, Madison:
Primary Outcome Measures:
- -- implement myocardial perfusion quantification for O15-labeled water at rest and with pharmacologic stress, [ Time Frame: assess at time of PET scan ] [ Designated as safety issue: No ]
- -- determine the biodistribution of fluoromethane in the thorax to see if it is usable for a cardiac perfusion tracer, [ Time Frame: assess at time of PET Scan ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- --develop initial methods for quantification of myocardial perfusion if applicable for labeled fluoromethane. [ Time Frame: assess at time of PET scan ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | January 2004 |
| Study Completion Date: | March 2004 |
| Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 1. Age 18 to 40 years old 2. Willing to provide written informed consent
Exclusion Criteria:
- 1. A history of CAD 2. A history of active bronchospasm or asthma on theophylline bronchodilators 3. A history of any cardiac risk factors including: HTN, Diabetes, Hyperlipidemia, Smoking, and premature CAD in immediate family member 4. A history of liver disease or other significant disease 5. Females who are pregnant or lactating
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205127
Locations
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
| Principal Investigator: | Charles K Stone, MD | Univeristy of Wisconsin |
More Information
No publications provided
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00205127 History of Changes |
| Other Study ID Numbers: | 2003-241 |
| Study First Received: | September 12, 2005 |
| Last Updated: | August 28, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Wisconsin, Madison:
|
Cardiac PET imaging Radiopharmaceutical tracers |
ClinicalTrials.gov processed this record on May 23, 2013