Status:
WITHDRAWN
Non-Invasive Measurement of Cardiac Output and Stroke Volume in PE
Lead Sponsor:
University of California, Los Angeles
Conditions:
Pulmonary Embolism
Pulmonary Embolus/Emboli
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pulmonary embolism impacts over 1 in 1000 adults annually and is the third leading cause of cardiovascular death after heart attack and stroke. The consequence of each PE is widely variable. Physiolog...
Detailed Description
This is a single center study to evaluate the use of non-invasive measurement of stroke volume and cardiac output to assess risk and response to treatment in patients with acute pulmonary embolism (PE...
Eligibility Criteria
Inclusion
- Patient ≥ 18 years of age.
- The patient must understand and sign informed consent form (ICF).
- Patients requiring intensive care unit (ICU) level care with a confirmed diagnosis of pulmonary embolism (PE) by computed tomography (CT) angiogram or endobronchial ultrasound (EBUS) prior to or within 4 hours of initiation of any PE therapy or intervention.
- If a patient already has non-invasive hemodynamic monitoring by the Edwards system or by other systems, such as the Cheetah NICOM system, as part of their standard of care, this patient can still be enrolled. If the patient is already being followed by another system such as NICOM, the Edwards system would be added to it as long as the patient consents.
Exclusion
- BMI \< 20 or BMI \> 35.
- Height less than 120 cm.
- Diagnosis of atrial fibrillation, moderate to severe aortic or mitral valve insufficiency or stenosis, scleroderma, or end-stage renal disease.
- Patients on extracorporeal membrane oxygenation (ECMO).
Key Trial Info
Start Date :
July 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04855370
Start Date
July 15 2025
End Date
January 31 2026
Last Update
December 22 2025
Active Locations (1)
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1
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095