NCT00205127

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Jan 2004

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

August 29, 2012

Status Verified

August 1, 2012

Enrollment Period

2 months

First QC Date

September 12, 2005

Last Update Submit

August 28, 2012

Conditions

Healthy Volunteers

Keywords

Cardiac PET imagingRadiopharmaceutical tracers

Outcome Measures

Primary Outcomes (2)

  • -- implement myocardial perfusion quantification for O15-labeled water at rest and with pharmacologic stress,

    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,

    assess at time of PET Scan

Secondary Outcomes (1)

  • --develop initial methods for quantification of myocardial perfusion if applicable for labeled fluoromethane.

    assess at time of PET scan

Interventions

Cardiac PET imaging- rest and pharmacological stressPROCEDURE

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Age 18 to 40 years old 2. Willing to provide written informed consent

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Study Officials

  • Charles K Stone, MD

    Univeristy of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

January 1, 2004

Primary Completion

March 1, 2004

Study Completion

March 1, 2004

Last Updated

August 29, 2012

Record last verified: 2012-08

Locations

US(1)