Exploratory Metabolomics Study of Exhaled Breath in Pulmonary Embolism (MetabolAir)

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

Study Overview

• Status: Terminated
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Other: Pulmonary embolism diagnosis by nuclear medicine imaging

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67000
    • University Hospital, Strasbourg, france

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Presence of pulmonary embolism; ≥ 1 noninfused and normoventilated segment(s) by pulmonary tomoscintigraphy	Other: Pulmonary embolism diagnosis by nuclear medicine imaging; nuclear medicine imaging
No pulmonary embolism; Pulmonary perfusion without anomaly (segmental or sub-segmental) by pulmonary tomoscintigraphy	Other: Pulmonary embolism diagnosis by nuclear medicine imaging; nuclear medicine imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
number and location of deficient segments on ventilation-perfusion pulmonary tomoscintigraphy.	number and location of deficient segments on ventilation-perfusion pulmonary tomoscintigraphy.	day 1

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Arnaud Agin, PhD, University Hospital, Strasbourg, france

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Metabolomics; Biomarkers; Breath Tests; Early diagnosis; Mass spectrometry; Volatile Organic Compounds
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: 7252

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No