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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT01856504
Eligibility Criteria:
Inclusion Criteria:
1. Consenting adult patients ≥18 years of age;
2. Suspected but without known prior history of CAD
3. Not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., AV nodal blockers such as beta blockers, calcium channel blockers or digoxin)
4. Glomerular filtration rate \>60 ml/min
5. CCTA and ICA within 1 week of each other with no interscan event (e.g., myocardial infarction or coronary revascularization)
Exclusion Criteria:
1. Incomplete ICA or CCTA;
2. Known CAD (prior myocardial infarction, PCI, CABG)
3. Atrial Fibrillation
4. Abnormal Renal Function (GFR \<60 ml/min)
5. Unwilling or unable to give consent
6. Non-cardiac illness with life expectancy \<1 year
7. Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
8. Pregnant women
9. Allergy to iodinated contrast agent
10. Contraindications to nitroglycerin
11. Systolic blood pressure ≤90 mm Hg
12. Contraindications to β blockers or nitroglycerin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01856504
Study Brief:
Protocol Section:
NCT01856504