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 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT06393894
Eligibility Criteria:
Inclusion criteria:
* Signed informed consent
* Early atherosclerosis defined as coronary atherosclerosis in men aged \<55 years and women \<65 years
* Coronary artery atherosclerosis with angiographically proven coronary vessel luminal stenosis ≥ 50% and ischaemia
* Coronary artery atherosclerosis with planned revascularization
* History of coronary artery revascularization (PTCA or coronary artery bypass surgery)
* Coronary vessel suitable for NIRS pullback
Exclusion criteria:
* Diabetes
* Total cholesterol ≥7 mmol/l and/or LDL ≥ 5 mmol/l
* family hypercholesterolemia
* positive family history of early cardiovascular disease (myocardial infarction, sudden cardiac death or cardiovascular disease of first degree relatives at young age - men \<55 years, women \<65 years)
* malignant or resistant hypertension ≥ 10 years
* body mass index ≥40 kg/m 2 )
* 20 or more pack years of smoking
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06393894
Study Brief:
Protocol Section:
NCT06393894