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

Completed

• Conditions: Pulmonary Embolism
• Interventions: Diagnostic Test: Test of biomarkers for PE in EBC

• Registration Number: NCT04010760
• 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, 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.

Study Timeline

• Study Start: 2019-04-08
• Study First Submitted: 2019-07-04
• Study First Submitted QC: 2019-07-04
• Study First Posted: 2019-07-08
• Primary Completion: 2020-05-30
• Study Completion: 2020-05-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PE confirmed	Test of biomarkers for PE in EBC	Patients admitted with confirmed pulmonary embolism.
PE suspected	Test of biomarkers for PE in EBC	Patients admitted with suspected, but not confirmed pulmonary embolism.
Controls	Test of biomarkers for PE in EBC	Healthy controls same gender and age (within af range of 10 years) as PE patients

Primary Outcome Measures

Name	Time	Method
Prediction of pulmonary embolism by use of biomarkers in the EBC	1-2 years	The primary outcome is prediction of pulmonary embolism by use of one or more novel biomarkers in the EBC.

Trial Locations

Locations (1)

Aalborg Hospital; 🇩🇰 Aalborg, Denmark