Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT01778218
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 18 years
2. Reversible perfusion defect indicative of CAD on a MIBI exercise/regadenoson study completed within 30 days prior to screening;
3. When possible, a coronary angiography will be clinically planned; patient and treating physician must be agreeable to completing the angiogram after the 99mTc-EC-DG exercise/regadenoson study in order for the procedure to be performed.
4. The patient is able to provide written informed consent to participate in this study
Exclusion Criteria:
1. Known cardiomyopathy or history of congestive heart failure (CHF) due to left ventricular systolic dysfunction (ejection fraction \< 40%)
2. A scheduled coronary angiogram that prevents the 99mTc-EC-DG exercise/regadenoson or rest study visits from being completed prior to the angiogram
3. Plans to begin new anti-anginal therapy prior to completing the 99mTc-EC-DG rest/stress study visits
4. Contraindication for provocative stress testing based on American College of Cardiology/American Heart Association (ACC/AHA) guidelines for exercise or pharmacologic testing
5. Intolerance or inability to receive sestamibi or regadenoson, or an inability or unwillingness to exercise on a graded treadmill or receive pharmacologic stress
6. Inability to lie still for 30 minutes during image acquisition
7. 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), or a partner with non-reversed vasectomy \> 40 days prior to entry.
8. Pregnant (positive human chorionic gonadotropin \[hCG\]) pregnancy test at screening for women of childbearing potential) or nursing
9. History of malignant disease (excluding treated basal cell or squamous cell carcinoma of skin, or low grade cancers that are stable and do not interfere with exercise which 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
10. 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
11. A known allergy to 99mTc-EC-DG or its components
12. 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
13. Received an investigational drug within 30 days prior to this study
14. Enrolled in or plans to enroll in another clinical trial during this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01778218
Study Brief:
Protocol Section:
NCT01778218