Exploratory Metabolomics Study of Exhaled Breath in Pulmonary Embolism

NCT04001179 | Terminated

• 1 other identifier: 7252
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Embolism

Keywords

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

Outcome Measures

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.

  Metabolites are collected immediately before pulmonary tomoscintigraphy

Secondary Outcomes (2)

• 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.

  day 1

Study Arms (2)

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

Pulmonary embolism diagnosis by nuclear medicine imaging OTHER

nuclear medicine imaging

No pulmonary embolism; Presence of pulmonary embolism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Male or female, at least 18 years old
• Patients with clinical suspected pulmonary embolism
• Patient willing and able to provide informed consent

You may not qualify if:

• Contraindications to pulmonary ventilator-perfusion tomoscintigraphy
• All types of thrombolytic or anticoagulant treatment
• Massive pulmonary embolism (systolic pressure \< 90 mm Hg)
• Pregnancy
• Breastfeeding

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

University Hospital, Strasbourg, france

Strasbourg, 67000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Exhaled breath (volatile organic compounds trapped on polymer cartridges)

MeSH Terms

Conditions

Pulmonary Embolism; Disease

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnaud Agin, PhD

  University Hospital, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 27, 2019
• Study Start: December 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 15, 2024
• Last Updated: August 29, 2024

Record last verified: 2023-08

Locations

FR (1)