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

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ClinicalTrials.gov Identifier: NCT04010760
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : September 18, 2019
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
Inger Lise Gade, 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.

Condition or disease Intervention/treatment
Pulmonary Embolism Diagnostic Test: Test of biomarkers for PE in EBC

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath Condensate
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
PE confirmed
Patients admitted with confirmed pulmonary embolism.
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.


PE suspected
Patients admitted with suspected, but not confirmed pulmonary embolism.
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.


Controls
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.





Primary Outcome Measures :
  1. Prediction of pulmonary embolism by use of biomarkers in the EBC [ Time Frame: 1-2 years ]
    The primary outcome is prediction of pulmonary embolism by use of one or more novel biomarkers in the EBC.


Biospecimen Retention:   Samples Without DNA
  1. Exhaled breath condensate (EBC)
  2. Plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

It is expected that

  • 40 patients with confirmed PE,
  • 40 patients with suspected PE, but where diagnostic work-up did not confirm PE and
  • 40 healthy controls

will be included in the study over a six-month period.

Criteria

Inclusion Criteria - Suspected/confirmed PE patients:

  • Admitted to the emergency department with initial diagnosis of PE, visited to the Department of Cardiology at Aalborg University Hospital.
  • 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.

Inclusion Criteria - Controls:

• Patients as the PE patients, but where the diagnosis of PE is rejected.

The rest of the control persons will be recruited as described:

  • Patients who are going to have elective procedures at the Department of Cardiology, Aalborg University Hospital.
  • 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010760


Contacts
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Contact: Inger L Gade, MD +4561656584 inlg@rn.dk
Contact: Lise T Elkjær lit@rn.dk

Locations
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Denmark
Aalborg Hospital Recruiting
Aalborg, Denmark, 9000
Sponsors and Collaborators
Aalborg University Hospital
University of Aarhus
Investigators
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Principal Investigator: Inger L Gade, MD Aalborg University Hospital
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Responsible Party: Inger Lise Gade, MD, PhD, Registrar, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT04010760    
Other Study ID Numbers: ILG-PE-2018
#0053310 ( Other Grant/Funding Number: The Novo Nordisk Foundation )
N-20180086 ( Other Identifier: Den Videnskabsetiske Komite for Region Nordjylland )
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases