Perikardbildgebungsstudie
Identifizierung klinischer, serumbasierter und bildgebender Biomarker im Zusammenhang mit Hochrisiko-Phänotypen für rezidivierende Perikarditis: Eine prospektive Kohortenstudie
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.
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 3
Kontakte und Standorte
Studienkontakt
- Name: Kevin Boczar, MD
- Telefonnummer: 613-696-7083
- E-Mail: KBoczar@ottawaheart.ca
Studieren Sie die Kontaktsicherung
- Name: Ashley Cowan, RN
- E-Mail: pmacphee@ottawaheart.ca
Studienorte
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-
Ontario
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Ottawa, Ontario, Kanada, K1Y 4W7
- Rekrutierung
- University of Ottawa Heart Institute
-
Kontakt:
- Ashley Cowan, RN
- Telefonnummer: 6136967000
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
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History of recurrent pericarditis* (i.e. presentation of at lease 2nd episode of acute pericarditis).
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Age >/= 18 years
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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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Pericardial contrast uptake on late gadolinium enhancement (LGE) on CMR
Zeitfenster: At Baseline
|
Pericardial imaging by CMR to evaluate inflammation |
At Baseline
|
|
Circumferential linear increased FDG signal uptake
Zeitfenster: baseline
|
Pericardial Imaging to indicate pericardial inflammation. |
baseline
|
|
Recurrent pericarditis
Zeitfenster: From baseline to 1 year
|
# of participants that experience pericarditis recurrence after the qualifying occurrence |
From baseline to 1 year
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Clinical Factor - Age
Zeitfenster: At Baseline
|
Participant Age |
At Baseline
|
|
Clinical Factor - Sex
Zeitfenster: At Baseline
|
Sex of participant |
At Baseline
|
|
Clinical Factor - Family history of auto-immune disease
Zeitfenster: baseline
|
Presence of family history of auto-immune disease |
baseline
|
|
Clinical Factor - Heart Rate
Zeitfenster: At Baseline
|
Resting Heart rate of >80beats per minute |
At Baseline
|
|
Serum biomarkers - C-Reactive Protein
Zeitfenster: At Baseline
|
C-Reactive protein levels |
At Baseline
|
|
Serum biomarkers - Erythrocyte sedimentation rate (ESR)
Zeitfenster: At Baseline
|
ESR level |
At Baseline
|
|
Serum biomarkers - carcinoembryonic antigen cell adhesion molecule 1 (CEACAM1)
Zeitfenster: At Baseline
|
CEACAM1 levels |
At Baseline
|
|
Serum biomarkers - MHC class I chain related protein A (MICA)
Zeitfenster: At Baseline
|
MICA levels |
At Baseline
|
|
Serum biomarkers - MHC Class I chain related protein B (MICB)
Zeitfenster: At Baseline
|
MICB levels |
At Baseline
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 20250237-01H
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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