Identifying Clinical, Serum, and Imaging Based Biomarkers Associated With High-Risk Phenotypes for Recurrent Pericarditis: A Prospective Cohort Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 44
- 主要终点
- Pericardial contrast uptake on late gadolinium enhancement (LGE) on CMR
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Recurrent pericarditis
This is a single arm study. Participants enrolled will complete blood and imaging tests.
干预措施: 18F-FDG PET/CT (Diagnostic Test)
结局指标
主要结局
Pericardial contrast uptake on late gadolinium enhancement (LGE) on CMR
时间窗: At Baseline
Pericardial imaging by CMR to evaluate inflammation
Circumferential linear increased FDG signal uptake
时间窗: baseline
Pericardial Imaging to indicate pericardial inflammation.
Recurrent pericarditis
时间窗: From baseline to 1 year
\# of participants that experience pericarditis recurrence after the qualifying occurrence
次要结局
- Clinical Factor - Age(At Baseline)
- Clinical Factor - Sex(At Baseline)
- Clinical Factor - Family history of auto-immune disease(baseline)
- Clinical Factor - Heart Rate(At Baseline)
- Serum biomarkers - C-Reactive Protein(At Baseline)
- Serum biomarkers - Erythrocyte sedimentation rate (ESR)(At Baseline)
- Serum biomarkers - carcinoembryonic antigen cell adhesion molecule 1 (CEACAM1)(At Baseline)
- Serum biomarkers - MHC class I chain related protein A (MICA)(At Baseline)
- Serum biomarkers - MHC Class I chain related protein B (MICB)(At Baseline)