Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath Condensate
Data Collection
Collected at a single point in time - Cross-sectionalCardiovascular Diseases+4
+ Embolism
+ Lung Diseases
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: April 8, 2019
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.110 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location