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)
Cell>Point LLC
Summary
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).
Description
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 n…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age \> 18 years 2. Either of the following: 1. Standard 99mTc-SPECT perfusion rest/stress study completed within 30 days prior to screening and a coronary angiography study is clinically planned after the 99mTc-C-DG rest and stress visits in this study 2. Coronary angiography study planned or completed within 30 days of screening and no coronary intervention has been performed and willingness to complete a standard 99mTc-SPECT rest/stress study 3. The patient is able to provide informed consent to participate in this study 4. No change in medical therapy between…
Interventions
- Diagnostic Test99mTc-Sestamibi
An injection of 99mTC-Sestamibi will be administered by IV push under medically observed conditions.
Location
- Tom Hennebry, MDOklahoma City, Oklahoma