Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath
Key facts
- Who runs it
- Aalborg University Hospital
- Where
- Denmark1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 88 people enrolled
- Started
- 11 Jan 2024
- Ended
- 31 Dec 2024
- Type of study
- Observational, 3 groups
- Treatments tested
- New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath.
- Record updated
- 13 January 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Active malignant disease (i.e., ongoing anti-cancer therapy or palliation)
- Current smokers
Other criteria
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
In this study, a new, non-invasive method for diagnosis of pulmonary embolism (PE) will be tested.
Read full original descriptionShow less
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.
The 3 groups in the trial
- PE confirmed
Patients admitted with confirmed pulmonary embolism.
Treatment: New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath.
- PE suspected
Patients admitted with suspected, but not confirmed pulmonary embolism.
Treatment: New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath.
- Controls
Healthy controls - same gender and age (within af range of 10 years) as PE patients.
Treatment: New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 13 January 2025