|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00205127 |
|
Date of registration:
|
12/09/2005 |
|
Primary sponsor: |
|
|
Public title:
|
Cardiac Water and Fluoromethane Cardiac PET
|
|
Scientific title:
|
Comparison of Cardiac Perfusion by O15-water and F17-fluoromethane PET |
|
Date of first enrolment:
|
January 2004 |
|
Target sample size:
|
10 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00205127 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Charles K Stone, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Univeristy of Wisconsin |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Healthy Volunteers
|
|
Intervention(s)
|
|
Procedure: Cardiac PET imaging- rest and pharmacological stress
|
|
Primary Outcome(s)
|
|
-- 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]
|
|
-- implement myocardial perfusion quantification for O15-labeled water at rest and with pharmacologic stress,
[Time Frame: assess at time of PET scan]
|
|
Secondary Outcome(s)
|
|
--develop initial methods for quantification of myocardial perfusion if applicable for labeled fluoromethane.
[Time Frame: assess at time of PET scan]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|