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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT04473560
Eligibility Criteria:
Inclusion Criteria:
1. Clinical symptoms and presentation consistent with pulmonary embolism (PE).
2. PE symptoms duration ≤ 14 days.
3. High risk PE patients with absolute contraindications to systemic thrombolysis or its failure (refractory circulatory collapse) not eligible for surgical embolectomy.
4. Intermediate-high risk PE patients with right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level with concomitant at least one of below criterium for minimum 24 hours:
1. Systolic blood pressure \> 90 mmHg and ≤ 100 mmHg
2. Heart rate ≥ 110/min,
3. Arterial blood saturation \<90% during spontaneous breathing (atm)
5. Intermediate-high risk PE patients with right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level with sudden occurrence of one or more of the below listed factors:
1. Systolic blood pressure \> 90 mmHg and ≤ 100 mmHg
2. Heart rate≥ 110/min,
3. Arterial blood saturation \<90% during spontaneous breathing (atm)
Exclusion Criteria:
1. Pregnancy.
2. Refusal to sign the informed consent form.
3. Presence of intracardiac thrombus.
4. Diagnosed thrombophilia.
5. Severe thrombocytopenia (platelets count below 20 000 µL).
6. History of severe or chronic pulmonary hypertension.
7. Serum creatinine level higher than 1.8 mg/dl.
8. Known serious and uncontrolled sensitivity to radiographic agents.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04473560
Study Brief:
Protocol Section:
NCT04473560