Status:
RECRUITING
Quantitative 3-Dimensional Chest CT Vascular Reconstruction Before and After Anticoagulation for Pulmonary Embolism
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Brief Summary
Design: U.S.-based, single-center, proof-of-concept study Brief Description: A standard clinical contrast-enhanced chest CT scan performed 48 hours after clinically-indicated standard anticoagulation...
Detailed Description
The pulmonary vascular response to ultrasound-facilitated, catheter-directed fibrinolysis for treatment of pulmonary embolism (PE) results in rapid improvement in patient symptoms and right ventricula...
Eligibility Criteria
Inclusion
- Inpatients diagnosed with acute PE, in whom clinical providers have elected to prescribe anticoagulation alone for treatment based on clinical grounds at BWH.
- Eligibility for the study will include patients over the age of 18 with bilateral proximal PE on CT (filling defect in ≥ 1 main, lobar, or segmental pulmonary artery), PE symptom duration ≤ 14 days, RV-to-LV diameter ratio ≥ 0.9 on contrast-enhanced chest CT, and a clinically-determined decision to pursue treatment with anticoagulation alone.
Exclusion
- Serum creatinine greater than 2 mg/dL
- GFR \< 60 mL/min
- Pregnancy (pregnancy test will have been done as standardly required by Radiology before the initial clinically-indicated, clinically-protocolled chest CT)
- Contrast allergy
- Treatment with any fibrinolytics-based technique, or surgical/ catheter embolectomy
- Expected hospital stay \< 48 hours. The length of stay will be determined by the treating provider prior to enrollment. Subjects will not extend their stay to 48 hours if they are deemed ready for discharge prior to the time.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04113421
Start Date
December 1 2019
End Date
November 30 2025
Last Update
September 16 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115