NCT04010760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

1.1 years

First QC Date

July 4, 2019

Last Update Submit

February 14, 2022

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

  • 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.

    1-2 years

Study Arms (3)

PE confirmed

Patients admitted with confirmed pulmonary embolism.

Diagnostic Test: Test of biomarkers for PE in EBC

PE suspected

Patients admitted with suspected, but not confirmed pulmonary embolism.

Diagnostic Test: Test of biomarkers for PE in EBC

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

Interventions

Test of biomarkers for PE in EBCDIAGNOSTIC_TEST

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.

ControlsPE confirmedPE suspected

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg Hospital

Aalborg, 9000, Denmark

Location

Related Publications (1)

  • Gade IL, Riddersholm SJ, Stilling-Vinther T, Brondum RF, Bennike TB, Honore B. A clinical proteomics study of exhaled breath condensate and biomarkers for pulmonary embolism. J Breath Res. 2023 Nov 17;18(1). doi: 10.1088/1752-7163/ad0aaa.

    PMID: 37939397DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Exhaled breath condensate (EBC) 2. Plasma

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Inger L Gade, MD

    Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Registrar

Study Record Dates

First Submitted

July 4, 2019

First Posted

July 8, 2019

Study Start

April 8, 2019

Primary Completion

May 30, 2020

Study Completion

May 31, 2020

Last Updated

February 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)