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:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-26 @ 5:20 PM
NCT ID:
NCT03139006
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years old;
* Suspected or known stable angina with pre-test likelihood of 50-85% for obstructive coronary disease, using the method recommended by the European Society of Cardiology 2013 Guidelines on the management of stable coronary artery disease (Eur Heart J 2013);
* Referred for invasive testing with fractional flow reserve;
* Willing and able to give informed consent. The consent procedures, as set by the Institutional Review Board (IRB) will be followed.
Exclusion Criteria:
* Subjects with suspected or known stable angina with pre-test likelihood of 0-50% using the method recommended by the European Society of Cardiology 2013 Guidelines on the management of stable coronary artery disease (Eur Heart J 2013 \[24\]);
* Subjects who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent or tolerate the coronary CTA examination;
* Subjects with (severe) renal insufficiency, indicated as glomerular filtration rate (GFR) \<60 ml/min;
* Subjects with unknown GFR or obtained \>3 months before the planned scan;
* Contraindication or allergy to intravenous contrast agent(s);
* Subjects who participate in an other study with radiation which is estimated to be in risk category III (ICRP 62);
* Subjects who are pregnant;
* Subjects with contraindications to cardiac CT and/or S\&S protocol, intravenous contrast, intravenous adenosine, betablockers or nitroglycerine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03139006
Study Brief:
Protocol Section:
NCT03139006