Trial Outcomes & Findings for Assessment of Coronary Artery Disease by Hybrid PET/CT (NCT NCT00320931)

Results Overview

All data were acquired in list-mode for 8 minutes and retrospectively sorted into static, ECG gated and dynamic images. Rubidium retention was calculated by dividing the late (3-8 minute) whole myocardium region-of-interest data by the integral of the input function over the first minute. Adenosine flow reserve was estimated by dividing rubidium retention during adenosine vasodilation by the same measure at rest. These quantitative flow and flow reserve values were compared to clinically acquired gated studies in the 30 participants.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

3-8 minute

Results posted on

2021-06-09

Participant Flow

The recruitment period was from 2006 to 2008 at the University of Maryland Medical Center

Enrolled participants who were claustrophobic did not complete the studies

Participant milestones

Participant milestones
Measure	Hybrid PET/CT The participants underwent rest and vasodilator rubidium PET and CT angiography studies using standard doses for clinically indicated studies
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Coronary Artery Disease by Hybrid PET/CT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Undergoing Imaging Studies n=30 Participants
Age, Continuous	30 over 18 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3-8 minute

Population: This study was terminated and the hybrid PET/CT scanner that was available to use for the study at the University of Maryland Medical Center was unable to generate quantitatively accurate absolute myocardial blood flow values. As such, we were unable to have scientifically accurate results and data to report.

All data were acquired in list-mode for 8 minutes and retrospectively sorted into static, ECG gated and dynamic images. Rubidium retention was calculated by dividing the late (3-8 minute) whole myocardium region-of-interest data by the integral of the input function over the first minute. Adenosine flow reserve was estimated by dividing rubidium retention during adenosine vasodilation by the same measure at rest. These quantitative flow and flow reserve values were compared to clinically acquired gated studies in the 30 participants.

Outcome measures

Outcome data not reported

Adverse Events

Subjects Undergoing Imaging Studies

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

Vasken Dilsizian, MD

University of Maryland, Baltimore

Phone: 410-328-6890

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place