Microvascular Injury and Distal Thrombosis in COVID-19

NCT04990505 | Completed

• 1 other identifier: MIND
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators aimed to better understand the pathophysiology of SARS-CoV-2 pneumonia in non-critically ill hospitalized patients secondarily presenting with clinical deterioration and increase in oxygen requirement

Conditions

SARS-CoV-2 Infection

Keywords

lung thrombosis; pulmonary embolism; lung scintigraphy; alveolar albumin uptake

Outcome Measures

Primary Outcomes (2)

• Scintigraphic pattern of peripheral lung thrombosis

  Determination of the number of patients/pulmonary segments with scintigraphic pattern of peripheral lung thrombosis on the basis of a mismatch between normal ventilation and abnormal perfusion

  During hospitalization

• Pulmonary microvascular injury

  Determination of the number of patients/pulmonary segments with evidence for microvascular injury on the basis of a lung 99mTc albumin retention, calculated as albumin uptake normalized by the macro-aggregates perfusion uptake

  During hospitalization

Secondary Outcomes (2)

• Prognosis evolution at 15 days

  15 days after hospitalization

• CT abnormalities prognostic value

  15 days after hospitalization

Interventions

lung ventilation/perfusion scintigraphy DIAGNOSTIC_TEST

Chest CT-scan will be performed with blocked inspiration. Lung ventilation/perfusion scintigraphy imaging will be performed within 24hrs after CT pulmonary angiography, 410MBq of Technegas will be inhaled by patients and ventilation tomography performed thereafter. Then, 185MBq 99mTc-macroaggegates will be injected intravenously followed by the perfusion tomography. A combined CT acquisition will be performed. The day following lung ventilation/perfusion scintigraphy, 740MBq of Tc99m labeled albumin will be intravenously administered. Cardiac gated-blood-pool scintigraphy will be then performed in best septal left anterior oblique and left profile according to specific parameters. 45-60 min after injection, a non-gated tomographic acquisition over the lungs will be done, with the same parameters than for PS SPECT, resulting in a late albumin acquisition.

Also known as: Chest CT-scan, CT pulmonary angiography, 99mTc-albumin gated-blood-pool scintigraphy

Eligibility Criteria

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

Study Population

Patients hospitalized in the COVID-19 Unit for SARS-CoV-2 pneumonia with oxygen requirement

You may qualify if:

• Non-critically ill patients hospitalized in the COVID-19 Unit of the Centre Hospitalier Princesse Grace of Monaco
• Presenting with a sudden clinical deterioration defined by a respiratory rate impairment and/or a rise of oxygen flow to reach a peripheral capillary oxygen saturation (SpO2) of more than 95% during at least 48 hours
• a diagnosis of pulmonary embolism was discarded by CT pulmonary angiography
• no clinical or biological (procalcitonin levels) evidence of lung superinfection
• without clinical evidence for LV dysfunction

You may not qualify if:

• Non confirmed COVID-19 pneumonia according to the WHO guidance by a positive result of RT-PCR assay of nasal and pharyngeal swabs,
• Patients without peripheral pulmonary ground-glass opacities or air-space consolidation on their chest CT scan at admission and common laboratory findings including lymphocytopenia, eosinopenia, significantly elevated markers of organ inflammation such as fibrinogen and C-reactive protein.
• Patients could not be included if their medical condition was unstable or precluded a safe transfer to the nuclear medicine department, if they were under mechanical ventilation (either non-invasive or invasive), if they required critical care unit, or in case of a pregnancy.

Sponsors & Collaborators

• Centre Hospitalier Princesse Grace: lead

Study Sites (1)

Centre Hospitalier Princesse Grace

Monaco, Monaco

Location

Related Publications (1)

• Maincent C, Perrin C, Chironi G, Baque-Juston M, Berthier F, Paulmier B, Hugonnet F, Dittlot C, Farhad RL, Renvoise J, Serrano B, Nataf V, Mocquot F, Keita-Perse O, Claessens YE, Faraggi M. Microvascular injuries, secondary edema, and inconsistencies in lung vascularization between affected and nonaffected pulmonary segments of non-critically ill hospitalized COVID-19 patients presenting with clinical deterioration. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221096040. doi: 10.1177/17534666221096040.

  PMID: 35485327 DERIVED

MeSH Terms

Conditions

COVID-19; Pulmonary Embolism

Interventions

Respiration; Perfusion Imaging

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)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Radionuclide Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 4, 2021
• Study Start: February 22, 2020
• Primary Completion: October 18, 2021
• Study Completion: February 28, 2022
• Last Updated: March 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)