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:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT03179592
Eligibility Criteria:
Inclusion Criteria:
1. Referred for a clinically indicated CCTA scan.
2. Subject must be 18 - 85 years of age.
3. Subject must provide written informed consent prior to any study-related procedures being performed.
4. Subject must be willing to comply with all clinical study procedures.
Exclusion Criteria:
1. Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
* By testing (serum or urine beta HCG) within 24 hours before study agent administration, or
* By surgical sterilization, or
* Post-menopausal, with minimum one (1) year history without menses.
2. Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that is not 70, 80, 90, 100, 110, 120, or 130 kV.
3. Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that has previously reached the maximum subject number (20 subjects per tube voltage).
4. Subject has an acute psychiatric disorder.
5. Subject is unwilling to comply with the requirements of the protocol.
6. Subject has previously entered this study.
7. Subject has an allergy against iodinated contrast agents or pharmaceutical stressors used in this study.
8. Subject has impaired renal function (creatinine \> 1.5 mg/dl).
9. Subject is in unstable condition.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03179592
Study Brief:
Protocol Section:
NCT03179592