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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 : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Matteo Montorfano, IRCCS San Raffaele

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 also evaluate the extension of microvascular pulmonary thrombosis in patients with contrast CT scan positive for pulmonary embolism in areas where contrast CT scan was negative.

Condition or disease Intervention/treatment Phase
Covid19 Pulmonary Embolism Diagnostic Test: Optical Coherence Tomography (OCT) Not Applicable

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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, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COVID-19 patient with pulmonary thrombosis
  • patients with COVID-19, high D-dimer levels and contrast CT scan negative for pulmonary thrombosis
  • patients with contrast CT scan positive for pulmonary embolism in areas where contrast CT scan was negative.
Diagnostic Test: Optical Coherence Tomography (OCT)
To perform OCT in pulmonary artery of patient with COVID-19




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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
Criteria

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

Information from the National Library of Medicine

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


Contacts
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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

Locations
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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   
Sponsors and Collaborators
IRCCS San Raffaele
  Study Documents (Full-Text)

Documents provided by Matteo Montorfano, IRCCS San Raffaele:
Study Protocol  [PDF] May 6, 2020

Publications:
Tearney GJ, Regar E, Akasaka T, Adriaenssens T, Barlis P, Bezerra HG, Bouma B, Bruining N, Cho JM, Chowdhary S, Costa MA, de Silva R, Dijkstra J, Di Mario C, Dudek D, Falk E, Feldman MD, Fitzgerald P, Garcia-Garcia HM, Gonzalo N, Granada JF, Guagliumi G, Holm NR, Honda Y, Ikeno F, Kawasaki M, Kochman J, Koltowski L, Kubo T, Kume T, Kyono H, Lam CC, Lamouche G, Lee DP, Leon MB, Maehara A, Manfrini O, Mintz GS, Mizuno K, Morel MA, Nadkarni S, Okura H, Otake H, Pietrasik A, Prati F, Räber L, Radu MD, Rieber J, Riga M, Rollins A, Rosenberg M, Sirbu V, Serruys PW, Shimada K, Shinke T, Shite J, Siegel E, Sonoda S, Suter M, Takarada S, Tanaka A, Terashima M, Thim T, Uemura S, Ughi GJ, van Beusekom HM, van der Steen AF, van Es GA, van Soest G, Virmani R, Waxman S, Weissman NJ, Weisz G; International Working Group for Intravascular Optical Coherence Tomography (IWG-IVOCT). Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. J Am Coll Cardiol. 2012 Mar 20;59(12):1058-72. doi: 10.1016/j.jacc.2011.09.079. Erratum in: J Am Coll Cardiol. 2012 May 1;59(18):1662. Dudeck, Darius [corrected to Dudek, Darius]; Falk, Erlin [corrected to Falk, Erling]; Garcia, Hector [corrected to Garcia-Garcia, Hector M]; Sonada, Shinjo [corrected to Sonoda, Shinjo]; Troels, Thim [corrected to Thim, Troels]; van Es, Gerrit-Ann [correct.

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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: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matteo Montorfano, IRCCS San Raffaele:
COVID-19
PULMONARY EMBOLISM
MICROCLOTS
OCT
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases