- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00205127
Cardiac Water and Fluoromethane Cardiac PET
August 28, 2012 updated by: University of Wisconsin, Madison
Comparison of Cardiac Perfusion by O15-water and F17-fluoromethane PET
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
-- implement myocardial perfusion quantification for O15-labeled water at rest and with pharmacologic stress,
Time Frame: assess at time of PET scan
|
assess at time of PET scan
|
|
-- 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
|
assess at time of PET Scan
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
--develop initial methods for quantification of myocardial perfusion if applicable for labeled fluoromethane.
Time Frame: assess at time of PET scan
|
assess at time of PET scan
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Charles K Stone, MD, Univeristy of Wisconsin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Actual)
March 1, 2004
Study Completion (Actual)
March 1, 2004
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
August 29, 2012
Last Update Submitted That Met QC Criteria
August 28, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 2003-241
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.