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 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT06565702
Eligibility Criteria:
Inclusion Criteria:
Subjects should meet all of the following requirements for inclusion in the study:
1. Both sexes; at least 30% of the subjects are male and at least 30% of the subjects are female.
2. Subject's age \> 12 years.
3. Arm circumference distribution:
1. At least 20% of the subjects should have arm circumference within each quarter interval of the total arm circumference range;
2. At least 10% of the subjects should have arm circumference within the upper one-eighth interval of the total arm circumference range;
3. At least 10% of the subjects shall have an arm circumference within the lower one-eighth interval of the total arm circumference range.
4. Blood pressure distribution:
1. At least 5% of subjects shall have a systolic blood pressure ≤100 mmHg (13.33 kPa);
2. At least 5% of subjects shall have a systolic blood pressure ≥ 160 mmHg (21.33 kPa);
3. At least 20% of subjects should have a systolic blood pressure ≥ 140 mmHg (18.66 kPa);
4. Diastolic blood pressure should be ≤60 mmHg (8.0 kPa) in at least 5% of subjects;
5. Diastolic blood pressure should be ≥100 mmHg (13.33 kPa) in at least 5% of subjects; (f) At least 20% of subjects should have a diastolic blood pressure ≥85 mmHg (11.33 kPa);
5. Subjects must be willing and able to comply with the study procedures by signing an informed consent form after being informed about the study.
consent form after understanding the contents of the study.
6. Good compliance and ability to complete the clinical trial.
Exclusion Criteria:
Subjects who fulfill any of the following requirements cannot be included in the study:
(1) Mental illness, impaired consciousness, or other conditions that prevent them from cooperating with the study; (2) Require hemodialysis; (3) Taking anticoagulant drugs for cardiovascular diseases; (4) Pregnant and lactating women; (5) Patients with cardiac arrhythmia; (6) Patients with peripheral arterial disease and diseases that may affect arterial compliance; (7) Other conditions that are considered by the physician to be unsuitable for enrollment.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT06565702
Study Brief:
Protocol Section:
NCT06565702