心包成像研究
识别与复发性心包炎高风险表型相关的临床、血清和影像学生物标志物：一项前瞻性队列研究
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Kevin Boczar, MD
- 电话号码：613-696-7083
- 邮箱：KBoczar@ottawaheart.ca
研究联系人备份
- 姓名：Ashley Cowan, RN
- 邮箱：pmacphee@ottawaheart.ca
学习地点
-
-
Ontario
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Ottawa、Ontario、加拿大、K1Y 4W7
- 招聘中
- University of Ottawa Heart Institute
-
接触：
- Ashley Cowan, RN
- 电话号码：6136967000
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pericardial contrast uptake on late gadolinium enhancement (LGE) on CMR
大体时间：At Baseline
|
Pericardial imaging by CMR to evaluate inflammation |
At Baseline
|
|
Circumferential linear increased FDG signal uptake
大体时间：baseline
|
Pericardial Imaging to indicate pericardial inflammation. |
baseline
|
|
Recurrent pericarditis
大体时间：From baseline to 1 year
|
# of participants that experience pericarditis recurrence after the qualifying occurrence |
From baseline to 1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clinical Factor - Age
大体时间：At Baseline
|
Participant Age |
At Baseline
|
|
Clinical Factor - Sex
大体时间：At Baseline
|
Sex of participant |
At Baseline
|
|
Clinical Factor - Family history of auto-immune disease
大体时间：baseline
|
Presence of family history of auto-immune disease |
baseline
|
|
Clinical Factor - Heart Rate
大体时间：At Baseline
|
Resting Heart rate of >80beats per minute |
At Baseline
|
|
Serum biomarkers - C-Reactive Protein
大体时间：At Baseline
|
C-Reactive protein levels |
At Baseline
|
|
Serum biomarkers - Erythrocyte sedimentation rate (ESR)
大体时间：At Baseline
|
ESR level |
At Baseline
|
|
Serum biomarkers - carcinoembryonic antigen cell adhesion molecule 1 (CEACAM1)
大体时间：At Baseline
|
CEACAM1 levels |
At Baseline
|
|
Serum biomarkers - MHC class I chain related protein A (MICA)
大体时间：At Baseline
|
MICA levels |
At Baseline
|
|
Serum biomarkers - MHC Class I chain related protein B (MICB)
大体时间：At Baseline
|
MICB levels |
At Baseline
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.