Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol
|ClinicalTrials.gov Identifier: NCT02136706|
Recruitment Status : Withdrawn (Sponsor and site were unable to complete a final contract to support the study)
First Posted : May 13, 2014
Last Update Posted : December 16, 2015
Encouraged by the recent data published ,the investigators think that a waiting time of 10 minutes is feasible while preserving diagnostic accuracy and would like to assess the feasibility and diagnostic efficacy of W10 compared with W30 imaging in a pilot study. By combining W10 imaging with half-time acquisition, the time of the technetium-99m myocardial perfusion imaging procedure could be shortened by at least 50%, lasting only 40 minutes for W10 (10-minute waiting) imaging compared with 90 minutes for W30 imaging (30-minute waiting).
The investigators hypothesize that (1) W10 MPI is clinically feasible and tolerable by the patients, that (2) W10 MPI provides high image quality and that (3) W10 MPI provides diagnostic accuracy comparable to W30 MPI.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Atherosclerosis||Procedure: Myocardial Perfusion imaging with 10 minute waiting period||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol: A Pilot Study|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2017|
No Intervention: 10/30 min rest/stress
Rest and stress T99m-MPI obtained 10 minutes and 30 minutes after tracer injection. After the myocardial perfusion imaging the investigators will have 10 minute waiting period to take images and then wait the 30 minutes, standard of care to take the images.
Procedure: Myocardial Perfusion imaging with 10 minute waiting period
After the Myocardial Perfusion Imaging testing the investigators will wait 10 minutes to take images and then wait the 30 minute standard of care time to take images.
- Visual and semi-quantitative evaluation of W10 and W30 studies. [ Time Frame: Day 1of testing ]The investigators will evaluate image quality of W10 and W30-qualitatively (visually) by 2 independent readers and semi-qualitatively by means of region of interest (ROI) count/pixels parameters of W10 and W30 data and compare their diagnostic accuracy for the diagnosis of myocardial ischemia and infarction.
- Tolerability Questionnaire [ Time Frame: Day 1 of testing ]Each patient will complete a total of 6 questionnaires on the day of testing before and after each stress W10 and W30 scanning. The participants will be asked to rate how they felt, and if present, how they perceived their headache during scanning. Patients will also be asked how they felt and how severe was their headache when comparing the rest W10 and W30 and the stress W10 and W30.
- Feasibility of W10 by written documentation. [ Time Frame: Day 1 of testing ]By documenting any technical or clinical difficulties during the W10 procedure