Pulmonary EmbolismMetabolAirNCT04001179
Exploratory Metabolomics Study of Exhaled Breath in Pulmonary Embolism
An observational study of Pulmonary Embolism, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Pulmonary embolism diagnosis by nuclear medicine imaging
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to 15 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Male or female, at least 18 years old
- Patients with clinical suspected pulmonary embolism
- Patient willing and able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Pulmonary embolism diagnosis by nuclear medicine imaging
- Keywords
- Early diagnosis, Mass spectrometry, Volatile Organic Compounds, Metabolomics, Breath Tests, Biomarkers
- Medical subject headings
- Pulmonary Embolism, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary embolism diagnosis by nuclear medicine imagingOther
nuclear medicine imaging
| Study group | Role | What they receive |
|---|---|---|
| Presence of pulmonary embolism | ≥ 1 noninfused and normoventilated segment(s) by pulmonary tomoscintigraphy Receives: Other: Pulmonary embolism diagnosis by nuclear medicine imaging | |
| No pulmonary embolism | Pulmonary perfusion without anomaly (segmental or sub-segmental) by pulmonary tomoscintigraphy Receives: Other: Pulmonary embolism diagnosis by nuclear medicine imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Metabolites are collected immediately before pulmonary tomoscintigraphy
Secondary outcomes (2)
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).
Measured: 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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start1 Dec 2021
- Primary completion1 Dec 2021
- Study completion15 Jan 2024
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Agin, PhD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001179
- Sponsor's protocol ID
- 7252
- Acronym
- MetabolAir
- Status last verified
- Aug 2023
- First submitted
- 20 Jun 2019
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Metabolomics Study of Exhaled Breath in Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT04001179
- Acronym / sponsor ID
- MetabolAir / 7252
- Conditions
- Pulmonary Embolism
- Keywords
- Early diagnosis, Mass spectrometry, Volatile Organic Compounds, Metabolomics, Breath Tests, Biomarkers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Presence of pulmonary embolism | – | Other: Pulmonary embolism diagnosis by nuclear medicine imaging≥ 1 noninfused and normoventilated segment(s) by pulmonary tomoscintigraphy |
| No pulmonary embolism | – | Other: Pulmonary embolism diagnosis by nuclear medicine imagingPulmonary perfusion without anomaly (segmental or sub-segmental) by pulmonary tomoscintigraphy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Male or female, at least 18 years old
- Patients with clinical suspected pulmonary embolism
- Patient willing and able to provide informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary embolism diagnosis by nuclear medicine imagingnuclear medicine imaging | Other | No pulmonary embolism, Presence of pulmonary embolism |
Primary outcome
quantitative comparison of metabolic profiles
Time frame: Metabolites are collected immediately before pulmonary tomoscintigraphy
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.
2 secondary outcomes
Wells score or revised Geneva score
Time frame: Clinical scores are collected immediately before pulmonary tomoscintigraphy
number and location of deficient segments on ventilation-perfusion pulmonary tomoscintigraphy.
Time frame: day 1
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud Agin, PhD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantitative comparison of metabolic profiles (time frame: Metabolites are collected immediately before pulmonary tomoscintigraphy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.