Status:
NOT_YET_RECRUITING
Efficacy and Saftey Study of 99mTc-ECDG in the Evaluation of Coronary Artery Disease (CAD)
Lead Sponsor:
Cell>Point LLC
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 doc...
Detailed 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...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Either of the following:
- 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
- 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
- The patient is able to provide informed consent to participate in this study
- No change in medical therapy between study procedures.
Exclusion
- Known cardiomyopathy or history of congestive heart failure (CHF) due to left ventricular systolic dysfunction (ejection fraction \< 40%)
- Starting a new anti-anginal drug or performance of revascularization prior to completing the 99mTc-EC-DG rest and stress study visits
- Contraindication for provocative stress testing based on American College of Cardiology/American Heart Association (ACC/AHA) guidelines for exercise or pharmacologic testing
- Intolerance or inability to receive sestamibi, tetrofosmin, or regadenoson, or an inability or unwillingness to exercise on a graded treadmill or receive pharmacologic stress
- Inability to lie still for approximately 30 minutes during image acquisition
- Women of childbearing potential, unless willing to use adequate contraception throughout the duration of the trial. Adequate contraception is considered hormonal contraception for \> 3 months prior to entry, intrauterine device (IUD) in place for at least 3 months, double barrier methods (condoms, diaphragm or spermicide), abstinence, or a partner with non-reversed vasectomy \> 40 days prior to entry.
- Pregnant or nursing
- History of malignant disease (excluding treated basal cell or squamous cell carcinoma of skin, or low grade cancers that are stable and not interfering with exercise may be allowed with permission from the Medical Monitor) within 5 years prior to screening. Resolution of a prior malignancy more than 5 years prior to screening must be deemed as cured by the investigator
- Any physical, psychological or substance abuse (drug or alcohol) condition which, in the opinion of the investigator, would interfere with the ability to provide informed consent or comply with study instructions or may adversely affect the safety of the patient if enrolled in this trial
- A known allergy to 99mTc-EC-DG or its components
- Inability to adhere to requirements specific to the study site's protocols for imaging and exercise/pharmacological stress testing, including but not limited to dietary restrictions and prohibited medications
- Received an investigational drug within 30 days prior to this study
- Prior bypass surgery
- Enrolled or plans to enroll in another clinical trial during this study
Key Trial Info
Start Date :
May 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01899833
Start Date
May 10 2025
End Date
April 1 2026
Last Update
April 1 2025
Active Locations (1)
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1
Tom Hennebry, MD
Oklahoma City, Oklahoma, United States, 73210