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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT05536960
Eligibility Criteria:
Inclusion Criteria:
* Aged 50 years and older
* Underwent CCTA imaging within 78 weeks from the screening visit
* Either CAD-RADS 4 or higher or 0/1 on CCTA.
* Able to provide written informed consent
Exclusion Criteria:
* History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI value of \< 45 ml/min/1,73m2.
* CVD events/revascularization in history
* Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
* Chronic or recent (\< 1 month) infections and/or clinical signs of acute infection.
* History of auto-immune diseases.
* Standard contra-indications to 68Ga-Dotatate PET, and CT based on physicians experience and current practices.
* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
* Elevated liver enzymes (\> 2 ULN of liver transaminases), acute liver failure or known liver disease.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT05536960
Study Brief:
Protocol Section:
NCT05536960