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 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT02886793
Eligibility Criteria:
Inclusion Criteria:
1. Patients with PAH:
* Hemodynamic diagnosis of precapillary pulmonary hypertension: PAPm ≥25 mmHg, PCWP ≤15 mmHg
* Exclusion of group 2,3,4 or 5
2. Patients with CTEPH:
* Hemodynamic diagnosis of precapillary pulmonary hypertension: PAPm ≥25 mmHg, PCWP ≤15 mmHg
* Persistence of thrombotic perfusion defects on pulmonary scintigraphy or angioCT, after 3 months or more of correct anticoagulant therapy
3. Healthy subjects
* No known disease or condition
* Normal lung function, chest x-ray, EKG and blood chemistry and haematology
Exclusion Criteria:
* Severe comorbidity.
* Pulmonary, pleural or rib cage disease interfering with FDG-PET acquisition
* Malignancy with exception of basocellular carcinoma
* Current smoker or former smoker (last 10 years or more than 10-year-pack).
* Pregnant or lactating women Hyperglycemia (fasting above 200 mg/dL)
* Hypersensitivity to the product or its excipients
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02886793
Study Brief:
Protocol Section:
NCT02886793