Prognostic Biomarkers in Patients With Acute Pericarditis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Development of of constrictive, recurrent or incessant pericarditis or poor response to NSAIDs treatment.
研究概览
简要总结
The study will aim at investigating novel plasma or imaging biomarkers in patients with acute pericarditis. All participants will be treated according to established clinical recommendations for the diagnosis and treatment of acute pericarditis.
Study participants will undergo blood sampling for measurements of plasma biomarkers potentially involved in the pathogenesis of acute pericarditis. Imaging datasets from available imaging tests will be used to quantify imaging biomarkers. Patients will be followed up prospectively for up to 18 months. The prognostic value of plasma and/or imaging biomarkers for development of complications such as atrial fibrillation, pericarditis recurrences, constrictive pericarditis and/or the need to switch to 2nd line treatment will be sought.
详细描述
Background: Acute pericarditis is a relatively common disorder with a reported incidence ranging from 3.32 to 27.7 cases per 100,000 persons per year in the Western word.Potential complications of acute pericarditis include pericarditis recurrence, cardiac tamponade and constrictive pericarditis.To date there is limited clinical evidence on prognostic factors of outcome in acute pericarditis; use of steroids/colchicine, the kinetics of C-reactive protein (CRP) in the acute phase and the underlying aetiology have been previously associated with recurrence of acute pericarditis. Nevertheless there are currently no established biomarkers to risk stratify patients with acute pericarditis.
Methods:
This will be a prospective observational study in three hundred (n=300) patients with a first diagnosis of acute pericarditis to explore the value of plasma or imaging biomarkers in predicting clinical outcome.
Written informed consent will be obtained obtained from all patients. The protocol has been approved by the Institutional Ethics Committee (ref. number 14167/20/08/2009) and will be carried out in accordance with the principles of the declaration of Helsinki.
Diagnosis of acute pericarditis and choice of treatment Acute pericarditis was diagnosed based on clinical recommendations. Baseline clinical and demographic data were recorded in all cases. In line with the current guidelines, diagnostic work-up included clinical history and examination, ECG, chest x-ray, echocardiography and routine blood tests including among others high-sensitivity cardiac troponin I and CRP.12 In patients with high risk features for secondary forms or complicated course13 additional tests will be performed at the discretion of the attending physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with first diagnosis of acute pericarditis
排除标准
- •Not willing to provide written consent
结局指标
主要结局
Development of of constrictive, recurrent or incessant pericarditis or poor response to NSAIDs treatment.
时间窗: Up to 18 months after hospital discharge
Participants will be followed-up by scheduled visits at the Outpatients' Clinic at 2 weeks, 1 month, 2 months post-hospital discharge and every 3 months thereafter (or earlier if symptomatic) up to a total of 18 months.
次要结局
- Development of new atrial fibrillation(Development of new atrial fibrillation at 7 days.)
研究者
George Lazaros
Consultant Cardiologist
Hippocration General Hospital
