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 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT04737408
Eligibility Criteria:
Inclusion Criteria:
1. Symptoms suggestive of stable coronary artery disease (CAD)
2. No known CAD
3. At least one coronary stenosis with \>49% lumen reduction determined by CT angiography
4. Sinus rhythm
5. At least one lesion with FFRCT \<0.81 (see below)
6. Life expectancy \>3 years
7. Fertile women must use safe contraception throughout the study period
8. Signed informed consent
5\. LDL cholesterol \>2.0 mM (patients already on lipid lowering medical therapy \< 3 months can be included if meeting all of the above mentioned criteria)
Exclusion Criteria:
1. Unstable angina
2. Known CAD
3. Body mass index \>40
4. Allergy to iodinated contrast media
5. Known statin intolerance
6. Poor coronary CT angiography image quality inadequate for FFRCT calculation (determined by core-laboratory)
7. Significant left main coronary artery (stenosis \>49%) or three-vessel CAD determined by coronary CT angiography leading to direct referral to ICA
8. FFRCT \<0.81 over the left main coronary artery or the proximal left anterior descendens artery (LAD) segment, or \<0.76 over the mid-LAD, proximal circumflex, right coronary artery or intermediate coronary segments
9. Pregnancy (women with age \>45 will be screened for pregnancy)
10. Moderate to severe liver failure
11. Estimated glomerular filtration rate (eGFR) \< 60 ml/min
12. Participation in another trial
13. Does noes not wish to participate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04737408
Study Brief:
Protocol Section:
NCT04737408