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 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT04148833
Eligibility Criteria:
Inclusion Criteria:
* Multi-vessels coronary artery disease diagnosis by coronary CTA scan or invasive angiography
* Aortic atherosclerosis diagnosis by multidetector computed tomography (MDCT) angiography.
* Signing the study informed consent.
Exclusion Criteria:
* History of AMI in the last 30 days
* Heart failure with ejection fraction \<40%
* Estimated glomerular filtration rate \< 40 mL/min/1.73 m2.
* Prior history of chronic infectious disease, including tuberculosis, severe fungal disease, or known HIV positive.
* Chronic hepatitis B or C infection.
* Prior history of nonbasal cell malignancy or myeloproliferative or lymphoproliferative disease within the past 5 years.
* White blood cell count \<4000/mm3, hematocrit \<32%, or platelet count \<75000/mm3.
* Alanine aminotransferase levels (ALT) greater than 3-fold the upper limit of normal.
* History of actual alcohol abuse or unwillingness to limit alcohol consumption to \< 4 drinks per week.
* Pregnancy or breastfeeding.
* Women of child bearing potential, even if currently using contraception.
* Men who plan to father children during the study period or who are unwilling to use contraception.
* Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers.
* Known chronic pericardial effusion, pleural effusion, or ascites.
* Angina pectoris CCS III-IV
* New York Heart Association class III-IV congestive heart failure.
* Contraindication for the use of iodinated contrast
* Life expectancy of \< 1 years.
* Acute or Chronic aortic dissection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04148833
Study Brief:
Protocol Section:
NCT04148833