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:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-24 @ 2:11 PM
NCT ID:
NCT04557995
Eligibility Criteria:
Inclusion:
1. High-altitude residents or long-term dwellers (defined as continuous residence at ≥2,500 meters above sea level for ≥1 year), with no history of travel to low-altitude areas in the preceding 2 months and no planned travel to low-altitude areas during the study period;
2. Aged more than 18 years, any gender;
3. Diagnosed with CMS per the Qinghai CMS Criteria: Hemoglobin (Hb): Men: ≥210 g/L Women: ≥190 g/L At least one symptom/sign: headache, dizziness, dyspnea and/or palpitations, sleep disturbances, fatigue, localized cyanosis, burning sensation in palms/soles, venous dilatation, muscle/joint pain, loss of appetite, poor concentration or memory changes. CMS score ≥6;
4. Women of childbearing potential: negative pregnancy test (serum/urine) at screening. No pregnancy plans during the study period;
5. Willing to sign informed consent and able to comply with study procedures.
Exclusion:
1. Hematocrit \<60%;
2. Patients with polycythemia due to: polycythemia vera, underlying cardiopulmonary diseases (e.g. COPD, chronic bronchitis, bronchiectasis, pulmonary fibrosis, heart disease), or other causes including malignancy;
3. Patients with active pneumonia, acute/chronic pulmonary embolism, or severe organ dysfunction (including cardiac, hepatic, or renal failure);
4. patients with contraindications to study procedures: erythrocytapheresis, pulmonary function tests, incremental shuttle walk test et al, including conditions such as pneumothorax, impaired consciousness, severe arrhythmia, or significant coagulation disorders et al.;
5. recent CMS-specific treatments (within the past 6 months): drug therapy, phlebotomy, or erythrocytapheresis;
6. pregnant or breastfeeding women;
7. current participation in other clinical trial (observational studies permitted).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04557995
Study Brief:
Protocol Section:
NCT04557995