Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath Condensate
Collecte de données
Données recueillies à un instant précis - TransversaleMaladies Cardiovasculaires+4
+ Embolisme
+ Maladies pulmonaires
Cas témoins
Analyse de profils avec et sans la maladie pour comprendre ce qui pourrait l'avoir favorisée.Résumé
Date de début de l'étude : 8 avril 2019
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.110 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cas témoins
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site