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

September 11, 2019

Overview

The Efficacy and Safety Study of 99mTc-ECDG in the Evaluation of Coronary Artery Disease compares the radiolabeled imaging agent to Sestamibi – the current testing method for CAD. The study investigates the testing during a rest and stress cardiac test.

 

Study Information

The study will enroll approximately 60 patients and divide them into two groups. Group 1 are patients who have been tested for CAD within 3-30 days and have planned a coronary angiography with their physician but it has not been performed yet. Group 2 is made up of patients who have had the coronary angiography but have not had any coronary intervention afterwards. Both groups will participate in the 99mTc-EC-DG rest study procedure, followed by two other protocols within the next few days. The studies will find several things about the CAD including the location, severity, and the arteries associated with the CAD.

 

Inclusion Criteria

  • Ages 18+
  • Patients able to provide informed consent
  • Patients with no change in medical therapy between study procedures
  • 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

 

Exclusion Criteria

  • 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

 

Location

Oklahoma City, Oklahoma, United States, 73210

Contact: B Hudson       bhudson@okheart.com  

Principal Investigator: Tom Hennebry, MD         

 

Collaborators/Sponsors

Cell>Point LLC

Principal Investigator: Gary Heller, MD, Consultant

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