An observational study in Pulmonary Embolism, sponsored by Aalborg University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-15.
Sponsored by Aalborg University Hospital · Observational
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.
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.
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's enrollment of 110 is below the median of 392 across 324 observational studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Aalborg University Hospital is the lead sponsor of 195 studies on the registry; 39 are open to participants now.
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It is expected that
will be included in the study over a six-month period.
Inclusion Criteria - Suspected/confirmed PE patients:
Inclusion Criteria - Controls:
The rest of the control persons will be recruited as described:
Exclusion Criteria:
Patients admitted with confirmed pulmonary embolism.
Diagnostic Test: Test of biomarkers for PE in EBC
Patients admitted with suspected, but not confirmed pulmonary embolism.
Diagnostic Test: Test of biomarkers for PE in EBC
Healthy controls same gender and age (within af range of 10 years) as PE patients
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.
Prediction of pulmonary embolism by use of biomarkers in the EBC
The primary outcome is prediction of pulmonary embolism by use of one or more novel biomarkers in the EBC.
Time frame: 1-2 years
Plan to share: No
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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Aalborg University Hospital