Clinical trial NCT04001179: Exploratory Metabolomics Study of Exhaled Breath in Pulmonary Embolism
Official title: Exploratory Metabolomics Study of Exhaled Breath in Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Embolism
Keywords: Early diagnosis
Mass spectrometry
Volatile Organic Compounds
Metabolomics
Breath Tests
Biomarkers
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients presenting to the Nuclear Medicine Department of our hospital for a pulmonary ventilation-perfusion tomoscintigraphy will be proposed to participate in the study

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


Eligibility criteria: 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

Primary outcomes:
measure: quantitative comparison of metabolic profiles
timeFrame: Metabolites are collected immediately before pulmonary tomoscintigraphy
Secondary outcomes:
measure: Wells score or revised Geneva score
timeFrame: Clinical scores are collected immediately before pulmonary tomoscintigraphy
measure: number and location of deficient segments on ventilation-perfusion pulmonary tomoscintigraphy.
timeFrame: day 1
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital, Strasbourg, france
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Arnaud Agin, PhD
role: PRINCIPAL_INVESTIGATOR
References: