NCT05353608

Brief Summary

A frequent complication of COVID-19 disease is pulmonary embolism (PE). Lung ventilation/perfusion (V/P) scintigraphy is a well-established test for PE diagnosis. The test is interpreted based on the recognition of wedge shaped perfusion mismatched defects. However, the ventilation procedure increases the potential risk of contamination by the aerosol secretion and the expired air. A variety of strategies have been proposed in the nuclear medicine literature regarding performance of lung ventilation scintigraphy in COVID-19 patients with suspected acute PE. However, there is currently no factual data in this specific population to support recommendations to the nuclear medicine community. The aim of this study was to assess the role of ventilation imaging when performing lung scintigraphy for suspected PE in COVID-19 patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
Last Updated

August 9, 2024

Status Verified

April 1, 2022

Enrollment Period

1 month

First QC Date

April 27, 2022

Last Update Submit

August 8, 2024

Conditions

Keywords

Lung scintigraphy

Outcome Measures

Primary Outcomes (1)

  • PE diagnosis on lung scintigraphy without the ventilation scan.

    Percentage of scans for which the diagnostic conclusion of the lung scan would have been different when omitting the ventilation scan

    1 day

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COVID-19 patients who underwent lung scintigraphy for suspected PE.

You may qualify if:

  • Patients with suspected COVID-19 disease
  • Referred for lung scintigraphy for suspected acute PE

You may not qualify if:

  • Patient under guardianship or curatorship
  • Patient deprived of liberty by an administrative or judicial decision
  • Inability or refuse to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Brest

Brest, 29609, France

Location

Cnetre Jean-Perrin

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Pulmonary EmbolismCOVID-19

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2022

First Posted

April 29, 2022

Study Start

April 30, 2021

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

August 9, 2024

Record last verified: 2022-04

Locations