心膜イメージング研究
再発性心膜炎の高リスク表現型に関連する臨床的、血清学的、画像学的バイオマーカーの同定：前向きコホート研究
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Kevin Boczar, MD
- 電話番号：613-696-7083
- メール：KBoczar@ottawaheart.ca
研究連絡先のバックアップ
- 名前：Ashley Cowan, RN
- メール：pmacphee@ottawaheart.ca
研究場所
-
-
Ontario
-
Ottawa、Ontario、カナダ、K1Y 4W7
- 募集
- University of Ottawa Heart Institute
-
コンタクト：
- Ashley Cowan, RN
- 電話番号：6136967000
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pericardial contrast uptake on late gadolinium enhancement (LGE) on CMR
時間枠：At Baseline
|
Pericardial imaging by CMR to evaluate inflammation |
At Baseline
|
|
Circumferential linear increased FDG signal uptake
時間枠：baseline
|
Pericardial Imaging to indicate pericardial inflammation. |
baseline
|
|
Recurrent pericarditis
時間枠：From baseline to 1 year
|
# of participants that experience pericarditis recurrence after the qualifying occurrence |
From baseline to 1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical Factor - Age
時間枠：At Baseline
|
Participant Age |
At Baseline
|
|
Clinical Factor - Sex
時間枠：At Baseline
|
Sex of participant |
At Baseline
|
|
Clinical Factor - Family history of auto-immune disease
時間枠：baseline
|
Presence of family history of auto-immune disease |
baseline
|
|
Clinical Factor - Heart Rate
時間枠：At Baseline
|
Resting Heart rate of >80beats per minute |
At Baseline
|
|
Serum biomarkers - C-Reactive Protein
時間枠：At Baseline
|
C-Reactive protein levels |
At Baseline
|
|
Serum biomarkers - Erythrocyte sedimentation rate (ESR)
時間枠：At Baseline
|
ESR level |
At Baseline
|
|
Serum biomarkers - carcinoembryonic antigen cell adhesion molecule 1 (CEACAM1)
時間枠：At Baseline
|
CEACAM1 levels |
At Baseline
|
|
Serum biomarkers - MHC class I chain related protein A (MICA)
時間枠：At Baseline
|
MICA levels |
At Baseline
|
|
Serum biomarkers - MHC Class I chain related protein B (MICB)
時間枠：At Baseline
|
MICB levels |
At Baseline
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。