Evaluating 99mTc-ECDG for Coronary Artery Disease

This study is looking at a new imaging agent called 99mTc-ECDG to see how well it can detect coronary artery disease (CAD), a condition where the heart's arteries narrow. Researchers will compare 99mTc-ECDG to a standard test called 99mTc-Sestamibi during rest and stress heart scans. The goal is to see if 99mTc-ECDG is effective and safe in finding the presence, location, and seriousness of CAD, as confirmed by a coronary angiogram (a procedure to look at your heart's blood vessels). About 60 adults aged 18 and older who have been evaluated for CAD and are planning or have recently had a coronary angiogram may be able to join. The study will measure how well 99mTc-ECDG works over approximately 3 to 20 days.

Study design
This is an open-label (meaning you and your doctors will know which treatment you are receiving), multi-center study involving about 60 participants.
What's involved
You would undergo a sequence of imaging procedures, including 99mTc-EC-DG rest and stress studies, and a 99mTc-SPECT MPI rest/stress study, over a period of approximately 3 to 20 days.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for efficacy is measured from Visit 1a through Visit 3, which is approximately 3 to 20 days.

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NCT01899833

Efficacy and Saftey Study of 99mTc-ECDG in the Evaluation of Coronary Artery Disease (CAD)

Not Yet Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Cell>Point LLC
~60 participants
Updated 2025-04-01 on ClinicalTrials.gov
What's tested:99mTc-Sestamibi

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy: Characterization of the efficacy of 99mTCc-ECDG in the evaluation of Coronary Artery Disease
Measured over Visit 1a through Visit 3 approximately 3 to 20 days
Coronary Artery Disease
1 sites across 1 states
Oklahoma1
  • Gary Heller, MD · PRINCIPAL_INVESTIGATOR · Consultant

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  • Efficacy: Characterization of the efficacy of 99mTCc-ECDG in the evaluation of Coronary Artery DiseaseVisit 1a through Visit 3 approximately 3 to 20 days

    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.