Trial Outcomes & Findings for PET/CT Study in the Diagnosis of Coronary Plaque (NCT NCT00850473)

Results Overview

Coronary FDG uptake will be measured at the site of coronary stenosis. The target coronary stenosis will be identified by its proximity to a clear anatomical landmark seen on CT and conventional angiography.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

During PET CT scan, an average of 2 hours

Results posted on

2018-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	Positron Emitting Image, F-18 FDG, Contrast Dye Patient will have a PET/CT imaging study to determine cardiac stenosis, patient will have an injection of F18 FDG to determine the metabolic uptake of the radio-isotope, patient will have contrast dye injected to better visualize the coronary arteries.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Positron Emitting Image, F18 FDG, Contrast Dye n=3 Participants Patient will have a PET/CT imaging study to determine cardiac stenosis, patient will have an injection of F18 FDG to determine the metabolic uptake of the radio-isotope, patient will have contrast dye injected to better visualize the coronary arteries.
Age, Categorical <=18 years	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=3 Participants
Age, Categorical >=65 years	0 Participants n=3 Participants
Sex: Female, Male Female	2 Participants n=3 Participants
Sex: Female, Male Male	1 Participants n=3 Participants
Region of Enrollment United States	3 Participants n=3 Participants

PRIMARY outcome

Timeframe: During PET CT scan, an average of 2 hours

Coronary FDG uptake will be measured at the site of coronary stenosis. The target coronary stenosis will be identified by its proximity to a clear anatomical landmark seen on CT and conventional angiography.

Outcome measures

Outcome measures
Measure	Positron Emitting Image n=3 Participants Patient will have a PET/CT imaging study to determine cardiac stenosis PET/CT: Patient will have a Positron Emitting Tomography imaging
Number of Participants With Clear Anatomical Landmarks Confirmed by CT	3 Participants

Adverse Events

Positron Emitting Image, F18 FDG, Contrast Dye

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Gropler, MD, Chief of Cardiovascular Imaging Laboratory

Washington University School of Medicine

Phone: 314-747-3877

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place