Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath
NCT06135220 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 88
Last updated 2025-01-13
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.
Conditions
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.
The collection time will be an average of 7 minutes. As the patient breathes through a mouthpiece, the exhaled breath is lead through the collection device, and an indicative amount af the exhaled air is led into a clear plastic bag. When the plastic bag is fully inflated, it indicates that the minimum required amount of exhaled breath (approximately 30 liters) has passed through the filter.
Sponsors & Collaborators
-
University of Aarhus
collaborator OTHER -
Aalborg University Hospital
lead OTHER
Principal Investigators
-
Inger L Gade, MD., Ph.D. · Aalborg University Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-01-11
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
Countries
- Denmark
Study Locations
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