NCT04010760

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Aalborg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In this study, a new, non-invasive method for diagnosis of pulmonary embolism (PE) will be tested. In pre-clinical studies, we have identified 151 putative biomarkers for pulmonary embolism in the exhaled breath condensate (EBC). These biomarkers needs validation/consolidation in a clinical setting before further test of this new diagnostic method.

Detailed description

The study will compare the protein profiles of EBC collected from patients admitted to the department of cardiology with suspected pulmonary embolism and controls with same age (within a range of 10 years) and gender from the outpatient clinic awaiting elective cardiovascular surgery. The main-outcome (i.e. means of the relative amounts of specific proteins in the EBC samples) will be compared by unpaired t-tests after assessment of normality and standard deviations within the three groups (PE confirmed, PE suspected but not confirmed and controls). Furthermore, sensitivity and specificity will be calculated for relevant proteins. The results from analysis of EBC samples from the patients and controls will be compared with results from the porcine model in order 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 EBC markers. In order to qualify the most suitable markers and substrates for standardization, the analysis of the EBC samples must be completed before the blood samples can be analyzed. Only biochemical, no genetic analysis will be conducted.

Conditions

• Pulmonary Embolism

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Test of biomarkers for PE in EBC	New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath condensate (EBC). The EBC will be collected by use of the RTube(R) system which has been used in previous studies of EBC. As the patient breathes through a mouth piece, the exhaled breath is led through a cooling chamber where the vaporous part of the exhaled breath condenses. We aim at collecting a total minimum of 3.0 mL EBC per study subject in order to have a sufficient amount of protein for the subsequent analysis. We aim at collecting exhaled breath condensate for 2\*15 minutes with the possibility to stop the collection after less than 15 minutes if the volume is sufficient.

Timeline

• Start date: 2019-04-08
• Primary completion: 2020-05-30
• Completion: 2020-05-31
• First posted: 2019-07-08
• Last updated: 2022-02-15

Locations

1 site across 1 country: Denmark