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

Completed

• Conditions: Pulmonary Embolism
• Interventions: 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.

• Registration Number: NCT06135220
• Lead Sponsor: Aalborg University Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-13
• Study First Posted: 2023-11-18
• Study Start: 2024-01-11
• Status Verified: 2024-02
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PE confirmed	New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath.	Patients admitted with confirmed pulmonary embolism.
PE suspected	New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath.	Patients admitted with suspected, but not confirmed pulmonary embolism.
Controls	New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath.	Healthy controls - same gender and age (within af range of 10 years) as PE patients.

Primary Outcome Measures

Name	Time	Method
Amount of exhaled pulmonary embolism-specific proteins	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

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark