Efficacy and Saftey Study of 99mTc=ECDG in the Evaluation of Coronary Artery Disease (CAD)
This study will compare how well a new radiolabeled imaging agent ECDG compares to the current testing for coronary artery disease (radiolabeled Sestamibi) during a rest and stress cardiac test as documented from results of a coronary angiogram (if performed).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Prospective, Open-label, Multicenter Study With Blinded Over-reading Characterizing the Efficacy and Safety of 99mTc-EC-DG in the Evaluation of Coronary Artery Disease (CAD)|
- Efficacy: Characterization of the efficacy of 99mTCc-ECDG in the evaluation of Coronary Artery Disease [ Time Frame: Visit 1a through Visit 3 approximately 3 to 20 days ] [ Designated as safety issue: No ]
1. Determine efficacy (sensitivity and specificity) of 99mTc-ED-DG: i. Compare efficacy of a rest and stress study at approximately 15 minutes post injection compared with efficacy of a standard 99mTc-SPECT rest/stress perfusion study for detecting the presence of CAD using invasive coronary angiography as the truth standard.* ii. Compare efficacy of a rest and stress study at approximately 60 minutes post injection compared with a standard 99mTc-SPECT rest/stress perfusion study for detecting the presence of CAD using invasive coronary angiography as the truth standard.*
* Images will be displayed using the standard Cedars Sinai tomographic display software which projects images in the short axis, vertical long, and horizontal long axis displays.
- Safety: The number of participants with Adverse Events [ Time Frame: From screeniing through up to 14 days after last study related procedure ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: 99mTc-EC-DG, Diagnostic
99mTc-EC-DG (25 ± 5 mCi, up to 250 µg EC-DG) will be administered by intravenous (IV) bolus injection.
An injection of 99mTC-ECDG with a target amount of 25 mCi with no more than 250 micrograms of ECDG will be administered by IV push under medically observed conditions.
Other Name: Technetium-99m-labeled Ethylenedicysteine-Deoxyglucose
This study will be a prospective, open-label, multi-center study assessing the efficacy and safety of 99mTc-EC-DG compared to 99mTc-SPECT MPI imaging for detecting the presence, location, and severity of CAD as established by coronary angiography. Approximately 60 patients will be enrolled in the study.
Group 1 will be patients who have been evaluated for CAD within 3 to 30 days by any cardiovascular diagnostic imaging method (nuclear, ultrasound, CTA, MRI, etc.) and their physician has planned for coronary angiography but angiography has not yet been performed. In addition, the patient has not had coronary artery bypass graft (CABG). These patients can be enrolled.
Group 2 will be patients who have been evaluated for CAD within 3 to 30 days by any cardiovascular diagnostic imaging method (nuclear, ultrasound, CTA, MRI, etc.) and the patient has already had coronary angiography performed but has not received any coronary intervention subsequent to the procedure.
The following sequence of imaging procedures will be performed for both Group 1 and 2 patients: The first procedure will be a 99mTc-EC-DG rest study. This will be followed within 24 hours to 3 days with a 1-day protocol 99mTc-SPECT MPI rest/stress study. This will be followed within 24 hours to 3 days with a 99mTc-EC-DG stress study.
For both Group 1 and 2, if 1 of the diagnostic imaging procedures performed to evaluate the presence of CAD was a traditional 99mTc-SPECT MPI rest/stress study, this procedure must be repeated as 1 of the 3 SPECT imaging procedures required by the trial protocol.
The modality for provocative stress testing (exercise, pharmacologic, or exercise/pharmacologic) will be matched between the 99mTc-SPECT study and the 99mTc-EC-DG study. All prospectively performed 99mTc-EC-DG and 99mTc-SPECT studies will be conducted using regadenoson as the pharmacologic stress agent. All imaging studies (99mTc-EC-DG, 99mTc-SPECT, coronary angiography) will be over-read by blinded, trained reviewers. The consensus blinded read will determine and record the location of the CAD by relating the wall of the myocardium affected to include: anterior, Inferior, lateral, septal and apex. The angiography study will identify the arteries associated with the CAD; namely, left anterior descending, circumflex or right coronary arteries. The study will also determine the severity of the CAD by visually comparing the size and intensity of the ischemic signal on rest and stress images obtained approximately 15 and 60 minutes post injection.
The results from the consensus blinded read of coronary angiography will be considered truth for the presence, location, and severity of obstructive CAD and degree of stenosis.
|Contact: Cynthia Phurroughemail@example.com|