Long-term Clinico-radiological Evolution of Patients With Symptomatic and Asymptomatic Brain Lesions During Infectious Endocarditis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Comparison of the proportion of patients with abnormal cerebral MRI (ischemic or haemorrhagic lesion, infection and cerebral aneurysm) detected at the initial evaluation during the IE acute phase and at the follow-up visit
研究概览
简要总结
Primary objective: To describe the evolution of cerebral lesions in IE patients (number of patients with abnormal cerebral MRI in acute phase of IE and during follow-up).
详细描述
Introduction:
Infectious endocarditis (IE) is a rare disease (1500 cases per year in France) with a poor prognosis (20 % of mortality). Neurological complications participate in the initial morbimortality but their long-term impact is poorly known. The acute neurological complications are symptomatic in approximately a quarter of patients. Neurological lesions are frequently observed using systematic cerebral imaging. In the IMAGE study, systematic cerebral MRI in 130 patients performed during the acute phase of IE allowed found cerebral lesion in 82 % of the patients and in 79 % of patients without neurological symptoms. The evolution of cerebral lesion, including brain micro-bleedings and their impact prognosis are not known.
Hypothesis: Cerebral lesions detected by MRI during the acute phase of infectious endocarditis may involve and may have an impact on functional prognosis.
Primary objective: To describe the evolution of cerebral lesions in IE patients (comparing the proportion of patients with abnormal cerebral MRI in acute phase of IE and during follow-up).
Secondary objectives:
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 Infective endocarditis treated in Bichat Claude Bernard hospital
- •Cerebral MRI performed during the acute phase of endocarditis
- •Resident in Metropolitan France
- •18 years old or more
排除标准
- •Refusal to participate
- •Contra indication to MRI scan
- •History of allergy to gadolinium
- •Pregnancy or lactating female
- •Lack of Social Security or CMU (recipient or beneficiary)
结局指标
主要结局
Comparison of the proportion of patients with abnormal cerebral MRI (ischemic or haemorrhagic lesion, infection and cerebral aneurysm) detected at the initial evaluation during the IE acute phase and at the follow-up visit
时间窗: 1 day
次要结局
- Rankin scale(1 day)
- Karnofsky scale(1 day)
- SF 36(1 day)
- IQCODE(1 day)
- WhOQOL(1 day)
- Neuropsychologic tests to assess cognitive, executive, language and memory functions (including MMS, BREF, Trail making test, Wisconsin card sorting test, STROOP)(1 day)
- CES-D scale(1 day)