Skip to content

Exploratory Metabolomics Study of Exhaled Breath in Pulmonary Embolism

Exploratory Metabolomics Study of Exhaled Breath in Pulmonary Embolism

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04001179
Acronym
MetabolAir
Enrollment
1
Registered
2019-06-27
Start date
2021-12-01
Completion date
2024-01-15
Last updated
2024-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism

Keywords

Early diagnosis, Mass spectrometry, Volatile Organic Compounds, Metabolomics, Breath Tests, Biomarkers

Brief summary

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

Interventions

OTHERPulmonary embolism diagnosis by nuclear medicine imaging

nuclear medicine imaging

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
quantitative comparison of metabolic profilesMetabolites are collected immediately before pulmonary tomoscintigraphyThe quantitative variables compared between the two contributive groups are the relative quantities of volatile organic compounds (metabolites) detected by chromatographic techniques coupled with mass spectrometry in exhaled air samples.

Secondary

MeasureTime frameDescription
Wells score or revised Geneva scoreClinical scores are collected immediately before pulmonary tomoscintigraphyThe first secondary outcome consists of the primary outcome (quantitative metabolic variables) to which are added quantitative variables of clinical probability score for pulmonary embolism (Wells score or revised Geneva score).
number and location of deficient segments on ventilation-perfusion pulmonary tomoscintigraphy.day 1number and location of deficient segments on ventilation-perfusion pulmonary tomoscintigraphy.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026