Pulmonary Optical Coherence Tomography in COVID-19 Patients

NCT04410549 | Completed DMC

• 1 other identifier: OCT COVID
• Study Type: interventional
• Target: 13
• Locations: 2 countries
• Sites: 2

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.

Conditions

Covid19; Pulmonary Embolism

Keywords

COVID-19; PULMONARY EMBOLISM; MICROCLOTS; OCT

Outcome Measures

Primary Outcomes (1)

• optical coherence tomography pulmonary microthrombosis assessment in COVID-19 pneumonia patients

  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.

  through study completion, an average of 1 month

Secondary Outcomes (3)

• Pulmonary artery vessel anatomy characterization

  through study completion, an average of 1 month

• Correlation between TTE pulmonary hypertension and right ventricular disfunction

  through study completion, an average of 1 month

• Correlations with standard inflammatory, coagulation and tissue damage

  through study completion, an average of 1 month

Study Arms (1)

COVID-19 patient with pulmonary thrombosis

EXPERIMENTAL

* 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)

Interventions

Optical Coherence Tomography (OCT) DIAGNOSTIC_TEST

To perform OCT in pulmonary artery of patient with COVID-19

COVID-19 patient with pulmonary thrombosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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
• \< 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (2)

Incor - Heart Institute - University of Sao Paulo

São Paulo, 01000, Brazil

Location

IRCCS San Raffaele

Milan, 20132, Italy

Location

Related Publications (11)

• Ciceri F, Beretta L, Scandroglio AM, Colombo S, Landoni G, Ruggeri A, Peccatori J, D'Angelo A, De Cobelli F, Rovere-Querini P, Tresoldi M, Dagna L, Zangrillo A. Microvascular COVID-19 lung vessels obstructive thromboinflammatory syndrome (MicroCLOTS): an atypical acute respiratory distress syndrome working hypothesis. Crit Care Resusc. 2020 Apr 15;22(2):95-97. doi: 10.51893/2020.2.pov2. Online ahead of print.

  PMID: 32294809 BACKGROUND

• Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.

  PMID: 32073213 BACKGROUND

• Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

  PMID: 32171076 BACKGROUND

• 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, Raber 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.

  PMID: 22421299 BACKGROUND

• Wijns W, Shite J, Jones MR, Lee SW, Price MJ, Fabbiocchi F, Barbato E, Akasaka T, Bezerra H, Holmes D. Optical coherence tomography imaging during percutaneous coronary intervention impacts physician decision-making: ILUMIEN I study. Eur Heart J. 2015 Dec 14;36(47):3346-55. doi: 10.1093/eurheartj/ehv367. Epub 2015 Aug 4.

  PMID: 26242713 BACKGROUND

• Li N, Zhang S, Hou J, Jang IK, Yu B. Assessment of pulmonary artery morphology by optical coherence tomography. Heart Lung Circ. 2012 Dec;21(12):778-81. doi: 10.1016/j.hlc.2012.07.014. Epub 2012 Aug 10.

  PMID: 22884790 BACKGROUND

• Hong C, Wang W, Zhong NS, Zeng GQ, Wu H. Using optical coherence tomography to detect peripheral pulmonary thrombi. Chin Med J (Engl). 2012 Sep;125(17):3171-4.

  PMID: 22932201 BACKGROUND

• Schwaiger JP, Loder CD, Dobarro D, Kaier T, Reddecliffe S, Schreiber BE, Handler C, Denton CP, Coghlan JG. Optical coherence tomography evaluation of pulmonary arterial vasculopathy in Systemic Sclerosis. Sci Rep. 2017 Feb 24;7:43304. doi: 10.1038/srep43304.

  PMID: 28233825 BACKGROUND

• Dai Z, Fukumoto Y, Tatebe S, Sugimura K, Miura Y, Nochioka K, Aoki T, Miyamichi-Yamamoto S, Yaoita N, Satoh K, Shimokawa H. OCT imaging for the management of pulmonary hypertension. JACC Cardiovasc Imaging. 2014 Aug;7(8):843-5. doi: 10.1016/j.jcmg.2014.01.020. No abstract available.

  PMID: 25124017 BACKGROUND

• van der Sijde JN, Karanasos A, van Ditzhuijzen NS, Okamura T, van Geuns RJ, Valgimigli M, Ligthart JM, Witberg KT, Wemelsfelder S, Fam JM, Zhang B, Diletti R, de Jaegere PP, van Mieghem NM, van Soest G, Zijlstra F, van Domburg RT, Regar E. Safety of optical coherence tomography in daily practice: a comparison with intravascular ultrasound. Eur Heart J Cardiovasc Imaging. 2017 Apr 1;18(4):467-474. doi: 10.1093/ehjci/jew037.

  PMID: 26992420 BACKGROUND

• Hajjar LA, Ancona MB, Filho RK, Tresoldi M, Caldas JG, Monti G, Carnevale FC, De Cobelli F, Moreira de Assis A, Ciceri F, Landoni G, Dijkstra J, Moroni F, Abizaid AAC, Willemann Ungaretti F, Carvalho Carmona MJ, De Backer D, Pompilio CE, de Britto FS Jr, Campos CM, Zangrillo A, Montorfano M. Microvascular lung vessels obstructive thromboinflammatory syndrome in patients with COVID-19: Insights from lung intravascular optical coherence tomography. Front Med (Lausanne). 2023 Feb 16;10:1050531. doi: 10.3389/fmed.2023.1050531. eCollection 2023.

  PMID: 36873865 DERIVED

MeSH Terms

Conditions

COVID-19; Pulmonary Embolism

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiology Unit Director

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 1, 2020
• Study Start: June 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); IT (1)