Microvascular Injury and Distal Thrombosis in COVID-19

NCT ID: NCT04990505

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-22
• Study Completion Date: 2022-02-28

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

Detailed Description

Investigators plan to consecutively enrol 25 patients without clinical or biological evidence for superinfection, without left ventricular dysfunction and for whom a pulmonary embolism was discarded by computed tomography pulmonary angiography. Investigators will investigate lung ventilation and perfusion (LVP) by LVP scintigraphy, and, 24 hours later, left and right ventricular function by 99mTc-labelled albumin gated-blood-pool scintigraphy with late (60 mn) tomographic albumin images on the lungs to evaluate lung albumin retention that could indicate microvascular injuries with secondary edema

Conditions

SARS-CoV-2 Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

lung ventilation/perfusion scintigraphy

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Chest CT-scan; CT pulmonary angiography; 99mTc-albumin gated-blood-pool scintigraphy

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Princesse Grace

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Princesse Grace

Monaco, , Monaco

Countries

Monaco

References

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.

Reference Type: DERIVED

PMID: 35485327 (View on PubMed)

Other Identifiers

MIND

Identifier Type: -

Identifier Source: org_study_id