Exploratory Metabolomics Study of Exhaled Breath in Pulmonary Embolism

Pulmonary Embolism Clinical Trial

— MetabolAir  

Official title:

Exploratory Metabolomics Study of Exhaled Breath in Pulmonary Embolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04001179
• Other study ID #: 7252
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: Arnaud Agin, PhD
• Phone: 03.88.12.88.56
• Email: arnaud.agin[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: November 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Other:
• Pulmonary embolism diagnosis by nuclear medicine imaging
nuclear medicine imaging

Locations

Country	Name	City	State
France	University Hospital, Strasbourg, france	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quantitative comparison of metabolic profiles	The 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.	Metabolites are collected immediately before pulmonary tomoscintigraphy
Secondary	Wells score or revised Geneva score	The 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).	Clinical scores are collected immediately before pulmonary tomoscintigraphy
Secondary	number and location of deficient segments on ventilation-perfusion pulmonary tomoscintigraphy.	number and location of deficient segments on ventilation-perfusion pulmonary tomoscintigraphy.	day 1