Status:
COMPLETED
Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath
Lead Sponsor:
Aalborg University Hospital
Collaborating Sponsors:
University of Aarhus
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
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 emb...
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 yea...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 11 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT06135220
Start Date
January 11 2024
End Date
December 31 2024
Last Update
January 13 2025
Active Locations (1)
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1
Aalborg University Hospital
Aalborg, Denmark