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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT01310751
Eligibility Criteria:
Inclusion Criteria:
Before corrective procedure for CHD, two of bellow ten criteria should be met
1. Pulse SaO2 smaller than 93% in left-right shunt CHD case (in room air)
2. EKG: right ventricular hypertrophy, right atrial dilatation
3. Chest X-ray: enhanced vascular signs in trans-hilar, loss of blood vessal in bilateral lung fields, pulmonary arterial trunk dilatation, right ventricular enlargement
4. Cardiac echocardiography: fast tricuspid or pulmonary valve regurgitant velocity, ventricular and aortic level bidirectional shunt, or even right-to-left shunt
5. Under-filling of pulmonary capillary, 'pruning' of the peripheral blood vessels
6. Pp/Ps greater than 0.75
7. Qp/Qs smaller than 1.5
8. PVR grater than 9 Wood Unit/m2
9. Rp/Rs graeter than 0.5
Exclusion Criteria:
After corrective procedure for CHD:
1. Deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation
2. Severe arrhythmia led to low cardiac output
3. PLT smaller than 50,000\*109/L and obvious bleeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Days
Maximum Age:
12 Years
Study:
NCT01310751
Study Brief:
Protocol Section:
NCT01310751