Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath (NILEX)

January 10, 2025 updated by: Inger Lise Gade, Aalborg University Hospital

In this study, a new, non-invasive method for diagnosis of pulmonary embolism (PE) will be tested.

In pre-clinical studies, the investigators have identified 151 putative biomarkers for pulmonary embolism in the exhaled breath, and several of these were also found in a first in-human clinical study what the investigators performed in 2019-2020 (DOI 10.1088/1752-7163/ad0aaa). These biomarkers need consolidation in a clinical setting using an updated collection device and proteomic analysis platform before development of a prototype and further test of this new diagnostic method.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will compare the protein profiles of exhaled breath from patients admitted to the Emergency Care Center with suspected pulmonary embolism and controls with same age (within a range of 10 years) and gender. The main-outcome (i.e., means of the relative amounts of specific proteins in the exhaled breath samples) will be compared by unpaired t-tests after assessment of normality and standard deviations within the two groups (PE patients and controls). Furthermore, sensitivity and specificity will be calculated for relevant proteins. The results from analysis of exhaled breath samples from the patients and controls will be compared with results from the porcine model and the first clinical study to confirm and reduce the number of putative biomarkers for PE.

Blood samples (i.e. excess plasma from routine blood samples drawn as a part of routine diagnostic work-up) from the study participants will be stored for standardization of the putative markers and verification and supplementing analysis of the exhaled breath markers. In order to qualify the most suitable markers and substrates for standardization, the analysis of the exhaled breath samples must be completed before the blood samples can be analyzed. Only biochemical, no genetic analysis will be conducted.

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Aalborg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

It is expected that 30 patients with confirmed PE, 30 patients with suspected PE, but where diagnostic work-up did not confirm PE and 30 healthy controls will be included in the study over a one-year period.

Description

PE patients:

  • Admitted to the Emergency Care Center with suspected PE
  • Are conscious and able to understand the given study information.
  • Possess legal capacity.
  • Age above 18 years.
  • Informed, signed consent is obtained.
  • Clinically stable, which is defined as patients with stable blood pressure and not in need for other treatments.
  • No need for organ support, which comprises need for vasopressors or inotropes, mechanical ventilation, extra corporal circulation, or renal replacement therapy.
  • In subjects, where the PE diagnosis is rejected after diagnostic work-up will be included in as clinical controls

Healthy controls:

The healthy age- and gender matched controls will be recruited as a:

• Random sample from the background population who wants to participate voluntarily on a first come, first served basis. They will be recruited from a hospital setting by using posters and by a social media campaign.

Inclusion criteria for healthy controls:

  • Same gender and age (within a 10-year range) as an included PE patient.
  • Are conscious and able to understand the given study information.
  • Possess legal capacity.
  • Age above 18 years.
  • Informed, signed consent is obtained.

Exclusion criteria for both PE patients and controls:

  • Active malignant disease (i.e., ongoing anti-cancer therapy or palliation).
  • Current smokers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PE confirmed
Patients admitted with confirmed pulmonary embolism.
Diagnostic test: New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath.
The collection time will be an average of 7 minutes. As the patient breathes through a mouthpiece, the exhaled breath is lead through the collection device, and an indicative amount af the exhaled air is led into a clear plastic bag. When the plastic bag is fully inflated, it indicates that the minimum required amount of exhaled breath (approximately 30 liters) has passed through the filter.
Other Names:
  • The exhaled breath will be collected by use of SensAbues which is a commercially available device for the purpose of the collection of proteins from exhaled breath.
PE suspected
Patients admitted with suspected, but not confirmed pulmonary embolism.
Diagnostic test: New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath.
The collection time will be an average of 7 minutes. As the patient breathes through a mouthpiece, the exhaled breath is lead through the collection device, and an indicative amount af the exhaled air is led into a clear plastic bag. When the plastic bag is fully inflated, it indicates that the minimum required amount of exhaled breath (approximately 30 liters) has passed through the filter.
Other Names:
  • The exhaled breath will be collected by use of SensAbues which is a commercially available device for the purpose of the collection of proteins from exhaled breath.
Controls
Healthy controls - same gender and age (within af range of 10 years) as PE patients.
Diagnostic test: New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath.
The collection time will be an average of 7 minutes. As the patient breathes through a mouthpiece, the exhaled breath is lead through the collection device, and an indicative amount af the exhaled air is led into a clear plastic bag. When the plastic bag is fully inflated, it indicates that the minimum required amount of exhaled breath (approximately 30 liters) has passed through the filter.
Other Names:
  • The exhaled breath will be collected by use of SensAbues which is a commercially available device for the purpose of the collection of proteins from exhaled breath.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of exhaled pulmonary embolism-specific proteins
Time Frame: 1-2 years
The primary outcome is diagnosis of pulmonary embolism by use of one or more novel protein biomarkers in the exhaled breath. The investigators will use semiquantitative analysis to identify the most suitable bomarkers already published: DOI: 10.3390/jcm10215165
1-2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Collaborators

University of Aarhus

Investigators

  • Principal Investigator: Inger L Gade, MD., Ph.D., Aalborg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILG-PE-2024
  • 108272 (Other Identifier: Den Videnskabsetiske Komite for Region Nordjylland)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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