Pulmonary Optical Coherence Tomography in COVID-19 Patients
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ClinicalTrials.gov Identifier: NCT04410549 |
Recruitment Status :
Recruiting
First Posted : June 1, 2020
Last Update Posted : February 25, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid19 Pulmonary Embolism | Diagnostic Test: Optical Coherence Tomography (OCT) | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Optical Coherence Tomography for Microvascular Lung Vessels Obstructive Thromboinflammatory Syndrome Assessment in Patients With COVID-19: an Exploratory Study |
Actual Study Start Date : | June 1, 2020 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: COVID-19 patient with pulmonary thrombosis
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Diagnostic Test: Optical Coherence Tomography (OCT)
To perform OCT in pulmonary artery of patient with COVID-19 |
- optical coherence tomography pulmonary microthrombosis assessment in COVID-19 pneumonia patients [ Time Frame: through study completion, an average of 1 month ]Study primary endpoints will be evaluation of OCT procedure overall safety in COVID-19 pneumonia patients and assessment of the presence of microvascular pulmonary thrombosis in COVID-19 patients, both in "ground glass" and "healthy" ventilated areas.
- Pulmonary artery vessel anatomy characterization [ Time Frame: through study completion, an average of 1 month ]
Pulmonary artery vessel anatomy characterization in COVID-19 pneumonia patients through OCT diagnostic technique
- Correlations with single trans-thoracic echocardiography (TTE) pulmonary hypertension (PH, estimated systolic pulmonary artery pressure > 35 mmHg) and right ventricular disfunction (RVD: tricuspid annular plane systolic excursion < 17 mm or Doppler tissue imaging S wave < 9.5 cm/sec).
- Dynamic correlations with standard inflammatory, coagulation and tissue damage biomarkers: CRP, ferritin, D-dimer, NT-proBNPO, troponins, LDH)
- Correlation between TTE pulmonary hypertension and right ventricular disfunction [ Time Frame: through study completion, an average of 1 month ]Correlations with single trans-thoracic echocardiography (TTE) pulmonary hypertension (PH, estimated systolic pulmonary artery pressure > 35 mmHg) and right ventricular disfunction (RVD: tricuspid annular plane systolic excursion < 17 mm or Doppler tissue imaging S wave < 9.5 cm/sec)
- Correlations with standard inflammatory, coagulation and tissue damage [ Time Frame: through study completion, an average of 1 month ]Pneumonia COVID-19 dynamic correlation with inflammation and coagulation markers

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
(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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410549
Contact: MATTEO MONTORFANO, PRINCIPAL INVESTIGATOR | 0226437331 ext 0039 | montorfano.matteo@hsr.it | |
Contact: MARCO BRUNO MARIA ANCONA, SUB INVESTIGATOR | 0226437331 ext 0039 | ancona.marco@hsr.it |
Brazil | |
Incor - Heart Institute - University of Sao Paulo | Recruiting |
São Paulo, Brazil, 01000 | |
Contact: LUDHMILA HAJJAR, MD ludhmilah@gmail.com | |
Italy | |
IRCCS San Raffaele | Recruiting |
Milano, Italy, 20132 | |
Contact: Matteo Montorfano, PI 0226437371 ext 0039 montorfano.matteo@hsr.it | |
Contact: Marco Bruno Maria Ancona, Sub Investigator 0226437371 ext 0039 ancona.marco@hsr.it |
Responsible Party: | Matteo Montorfano, Interventional Cardiology Unit Director, IRCCS San Raffaele |
ClinicalTrials.gov Identifier: | NCT04410549 |
Other Study ID Numbers: |
OCT COVID |
First Posted: | June 1, 2020 Key Record Dates |
Last Update Posted: | February 25, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 PULMONARY EMBOLISM MICROCLOTS OCT |
Pulmonary Embolism Embolism Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |