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TerminatedNCT04001179MetabolAirUpdated Aug 29, 2024

Exploratory Metabolomics Study of Exhaled Breath in Pulmonary Embolism

An observational study in Pulmonary Embolism, sponsored by University Hospital, Strasbourg, France. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-29.

Sponsored by University Hospital, Strasbourg, France · Observational

Why this study was terminated
recruitment difficulties
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
1
Ages
18 Years and older
Sex
All
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Study 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
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Conditions studied

  • Pulmonary Embolism

Keywords

  • Early diagnosis
  • Mass spectrometry
  • Volatile Organic Compounds
  • Metabolomics
  • Breath Tests
  • Biomarkers
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In context

Pulmonary Embolism

739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.

This study's enrollment of 1 is below the median of 392 across 324 observational studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 968 studies on the registry; 344 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
1 participant (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Presence of pulmonary embolism

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

    Other: Pulmonary embolism diagnosis by 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

Interventions

  • OtherPulmonary embolism diagnosis by nuclear medicine imaging

    nuclear medicine imaging

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Metabolites are collected immediately before pulmonary tomoscintigraphy

Secondary outcomes

  1. 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).

    Time frame: Clinical scores are collected immediately before pulmonary tomoscintigraphy

  2. number and location of deficient segments on ventilation-perfusion pulmonary tomoscintigraphy.

    number and location of deficient segments on ventilation-perfusion pulmonary tomoscintigraphy.

    Time frame: day 1

07

Study locations

1 site
  • University Hospital, Strasbourg, france
    Strasbourg, 67000, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04001179
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Jun 27, 2019
Start date
Dec 1, 2021
Primary completion
Dec 1, 2021
Completion
Jan 15, 2024
Last update
Aug 29, 2024

Study contacts

Arnaud Agin, PhD
principal investigator · University Hospital, Strasbourg, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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