Status:
COMPLETED
Pulmonary Optical Coherence Tomography in COVID-19 Patients
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Covid19
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate by intravascular OCT study the presence of microvascular pulmonary thrombosis in patients with COVID-19, high D-dimer levels and contrast CT scan negative for pulmonary thrombosis. We'll a...
Detailed Description
Background:Severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) infection represents a pandemic emergency of dramatic proportions. The clinical course of SARS-CoV-2 infection often meets the ...
Eligibility Criteria
Inclusion
- (part A)
- Severe pulmonary coronarvirus disease 19 (COVID 19) with suspect for MicroCLOTS (microvascular COVID-19 lung vessels obstructive thromboinflammatory syndrome) AND
- Contrast CT scan negative for pulmonary thrombosis AND
- D-Dimer \> 10 mcg/mL OR
- 5 \< D-dimer \< 10 mcg/mL and either C Reactive Protein (CRP) \> 100 mg/dL or IL-6 \> 6 pg/mL or ferritin \> 900 ng/L
- (part B)
- Severe pulmonary coronarvirus disease 19 (COVID 19) with suspect for MicroCLOTS (microvascular COVID-19 lung vessels obstructive thromboinflammatory syndrome) AND
- Contrast CT scan positive for pulmonary thrombosis
Exclusion
- Age \< 18
- Pregnancy or breastfeeding
- Known allergy to iodinated contrast dye
- Hemodynamic instability
- Glomerular Filtration rate \< 30 ml/min
- Active bleeding or absolute contraindication to anticoagulant therapy
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04410549
Start Date
June 1 2020
End Date
September 30 2021
Last Update
October 27 2021
Active Locations (2)
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1
Incor - Heart Institute - University of Sao Paulo
São Paulo, Brazil, 01000
2
IRCCS San Raffaele
Milan, Italy, 20132