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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT06378333
Eligibility Criteria:
Inclusion criteria:
* Patients with ischemic symptoms at rest or minor exercise without evidence of acute myocardial necrosis.
* Ischemic symptoms may include typical or atypical angina pectoris and worsening/deterioration of previously stable angina with or without electrical signs of ischemia on the electrocardiogram.
* hs-cTn concentrations are in the normal range or may be slightly elevated \> 99th percentile (i.e. low troponin T elevation ≤ 50 \* Elecsys Roche) but with absence of significant kinetics according to criteria defined in the literature (\<20%).
* One of the following angiographic criteria is required:
* Coronary angiography revealing a stenosis with a diameter of at least 70%.
* Stenosis of at least 50% diameter in the left common trunk.
* FFR (Fractional Flow Reserve) documenting ischemia per coronary angiography of a coronary lesion in the case of intermediate stenosis (50-70%).
* If there are no significant lesions, a spasm must be proven by an ergonovine test.
Exclusion criteria:
* NSTEMI and STEMI.
* Coronaries normal or without significant lesions unless proven spasm.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT06378333
Study Brief:
Protocol Section:
NCT06378333