Étude d'imagerie péricardique
Identification des biomarqueurs cliniques, sériques et d'imagerie associés aux phénotypes à haut risque de péricardite récurrente : une étude de cohorte prospective
The pericardium is a thin, double-layered sac around the heart that helps reduce friction as the heart moves. When this sac gets inflamed, it is called pericarditis, which can cause serious health problems and even be life-threatening. Pericarditis often comes back after the first episode. About 10-30% of people will have it again, and half of those will have it multiple times. Although there are treatments available, they are costly and not often used because we can't predict who best to use them on. Finding a way to predict which patients would benefit from these treatments could help reduce the burden on patients and the healthcare system.
This study will use a test called an 18F-FDG PET/CT with CTA Scan (18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) with computer tomography angiography (CTA)) to measure inflammation in the pericardium.
The purpose of the study is to create easy-to-use tools for doctors to identify people at high risk of pericarditis coming back, so they can get advanced treatment early. This study will help fill knowledge gaps about key predictors like clinical signs, blood tests, and imaging results.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This is a single-center, prospective cohort study designed to compare imaging biomarkers identified by CMR and FDG PET between patients who experience recurrent pericarditis and those who do not. In this prospective study, 44 patients will be recruited from the Ottawa Pericardial Clinic, all with a history of recurrent pericarditis. These patients will be followed prospectively for a period of one year.
It is hypothesized that patients who develop further episodes of recurrent pericarditis will exhibit significantly elevated markers of pericardial inflammation on both FDG PET/CT imaging as well as CMR imaging.
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: Kevin Boczar, MD
- Numéro de téléphone: 613-696-7083
- E-mail: KBoczar@ottawaheart.ca
Sauvegarde des contacts de l'étude
- Nom: Ashley Cowan, RN
- E-mail: pmacphee@ottawaheart.ca
Lieux d'étude
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y 4W7
- Recrutement
- University of Ottawa Heart Institute
-
Contact:
- Ashley Cowan, RN
- Numéro de téléphone: 6136967000
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
-
History of recurrent pericarditis* (i.e. presentation of at lease 2nd episode of acute pericarditis).
-
Age >/= 18 years
-
Given informed consent
- standard definitions will be used to define an episode of pericarditis. Pericarditis will be diagnosed by using available published criteria, which includes typical pericardial chest pain, pericardial friction rubs, widespread ST segment elevation or PR-segment depression that was not previously reported and new or worsening pericardial effusion on echocardiography. A clinical diagnosis of acute pericarditis will be made when at least 3 of these criteria are present.
Exclusion Criteria:
- severe valve disease requiring intervention
- claustrophobia that precludes FDG/PET or CMR imaging
- pregnancy (all women of child bearing potential will have a negative BHCG test)
- breastfeeding
- glomerular filtration rate (GFR) <50 m/min/1.72m2
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Recurrent pericarditis
This is a single arm study. Participants enrolled will complete blood and imaging tests. |
The participants will under an 18F-FDG PET/CT with CTA. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pericardial contrast uptake on late gadolinium enhancement (LGE) on CMR
Délai: At Baseline
|
Pericardial imaging by CMR to evaluate inflammation |
At Baseline
|
|
Circumferential linear increased FDG signal uptake
Délai: baseline
|
Pericardial Imaging to indicate pericardial inflammation. |
baseline
|
|
Recurrent pericarditis
Délai: From baseline to 1 year
|
# of participants that experience pericarditis recurrence after the qualifying occurrence |
From baseline to 1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinical Factor - Age
Délai: At Baseline
|
Participant Age |
At Baseline
|
|
Clinical Factor - Sex
Délai: At Baseline
|
Sex of participant |
At Baseline
|
|
Clinical Factor - Family history of auto-immune disease
Délai: baseline
|
Presence of family history of auto-immune disease |
baseline
|
|
Clinical Factor - Heart Rate
Délai: At Baseline
|
Resting Heart rate of >80beats per minute |
At Baseline
|
|
Serum biomarkers - C-Reactive Protein
Délai: At Baseline
|
C-Reactive protein levels |
At Baseline
|
|
Serum biomarkers - Erythrocyte sedimentation rate (ESR)
Délai: At Baseline
|
ESR level |
At Baseline
|
|
Serum biomarkers - carcinoembryonic antigen cell adhesion molecule 1 (CEACAM1)
Délai: At Baseline
|
CEACAM1 levels |
At Baseline
|
|
Serum biomarkers - MHC class I chain related protein A (MICA)
Délai: At Baseline
|
MICA levels |
At Baseline
|
|
Serum biomarkers - MHC Class I chain related protein B (MICB)
Délai: At Baseline
|
MICB levels |
At Baseline
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20250237-01H
Informations sur les médicaments et les dispositifs, documents d'étude
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