Exploratory Metabolomics Study of Exhaled Breath in Pulmonary Embolism

NCT ID: NCT04001179

Last Updated: 2024-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-01-15

Brief Summary

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Pulmonary embolism is a frequent and recurrent pathology, especially in the elderly. It is often preventable, with high mortality and morbidity, making it a major public health issue. The clinical presentation of pulmonary embolism is non-specific and very highly variable, ranging from asymptomatic thrombus diagnosed incidentally to sudden death. The current diagnosis of pulmonary embolism is based on several diagnostic techniques, mainly non-invasive, which should be used sequentially.

We propose to sample the volatile organic compounds using a device that allows them to be trapped on polymer cartridges. Sampling will be performed under monitoring of respiratory pressure and a capnograph to collect alveolar and upper respiratory tract air separately without contamination of the oral cavity or sinuses.

This exploratory metabolic analysis will be non-targeted (analysis of all molecules detectable without a priori).

The main objective of the study is to identify specific metabolic profiles to predict the results of ventilation-perfusion pulmonary tomoscintigraphy in subjects undergoing this examination for suspected acute pulmonary embolism.

Secondary purposes :

* To identify metabolic profiles to be used to predict, in combination with clinical probability scores, the results of ventilation-perfusion pulmonary tomoscintigraphy in subjects undergoing this examination for suspected acute pulmonary embolism.;
* To correlate metabolic profiles with the topography of embolized lung territories

Detailed Description

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Conditions

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Pulmonary Embolism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Presence of pulmonary embolism

≥ 1 noninfused and normoventilated segment(s) by pulmonary tomoscintigraphy

Pulmonary embolism diagnosis by nuclear medicine imaging

Intervention Type OTHER

nuclear medicine imaging

No pulmonary embolism

Pulmonary perfusion without anomaly (segmental or sub-segmental) by pulmonary tomoscintigraphy

Pulmonary embolism diagnosis by nuclear medicine imaging

Intervention Type OTHER

nuclear medicine imaging

Interventions

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Pulmonary embolism diagnosis by nuclear medicine imaging

nuclear medicine imaging

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female, at least 18 years old
* Patients with clinical suspected pulmonary embolism
* Patient willing and able to provide informed consent

Exclusion Criteria

* Contraindications to pulmonary ventilator-perfusion tomoscintigraphy
* All types of thrombolytic or anticoagulant treatment
* Diagnosis of pulmonary embolism established prior to inclusion in the study
* Massive pulmonary embolism (systolic pressure \< 90 mm Hg)
* Pregnancy
* Breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arnaud Agin, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Strasbourg, France

Locations

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University Hospital, Strasbourg, france

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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7252

Identifier Type: -

Identifier Source: org_study_id

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