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临床试验/NCT00982176
NCT00982176已完成不适用

Anatomo-functional Determinants of Cognitive Impairment After Acute Coronary Syndrome: A Brain MRI and Cerebral Perfusion Scintigraphy Study

University Hospital, Bordeaux4 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2009年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
49
试验地点
4
主要终点
the extent of white matter vascular lesions (leuko encephalopathy) and impairment in executive functions

研究概览

简要总结

The general purpose of the present pathophysiological study is to investigate the relation between cognitive impairment observed after an acute coronary syndrome and the presence of cerebral anatomo-functional abnormalities. This study will improve the investigators' understanding of the disease and will help in early diagnosis and prevention of vascular dementia in this population.

详细描述

Cognitive impairment is observed in more than 30% of the patients from 3 to 6 months after an acute coronary syndrome. Executive functions are mainly impaired. Cognition tends to progressively deteriorate during the following years, therefore increasing the risk of vascular dementia. Increased age and low educational level are the main risks factors whereas the risk is not modified by the strategy used to obtain a coronary revascularization. Brain imaging studies have demonstrated a vascular leukoencephalopathy in 50% of the patients with a previous history of ischaemic heart disease. However the link between brain anatomo-functional changes and occurrence of cognitive dysfunction remains largely unknown.

50 patients will be included in this study.

Cognition will be evaluated using a standard neuropsychological assessment (investigating executive function, memory, attention, language and visuo-constructive abilities) and a 7 days experience sampling method which evaluates cognition in daily life. Brain anatomo-functional study will include a brain MRI and two Tc-99m-HMPAO SPECT performed respectively with and without intravenous injection of acetazolamide in order to measure cerebral blood-flow and cerebrovascular reserve capacity.

Prospective exploratory study performed in a cohort of patients admitted for evaluation of their cardio-vascular risk factor 4 ±1 months after an acute coronary syndrome.

Patients will be included 4 ± 1 months after a first episode of acute coronary syndrome. A standard neuropsychological assessment will be performed by a neuropsychologist at inclusion and 6 months later. The daily life experience study will be performed during a period of 7 consecutive days following the inclusion. Questions will be asked to the patients 5 times a day by a pocket computer (Palm). MRI will be performed on a 3 Tesla research MRI. Two Tc-99m-HMPAO SPECT studies will be performed, the first one at inclusion and the second one more than 2 days and less than 15 days after the first. The second SPECT study will be performed after intravenous injection of acetazolamide.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female
  • Age :30 to 65 years
  • First acute coronary syndrome occurred 4 ± 1 months before the inclusion
  • Able to understand the use of a pocket computer (palm)
  • Able to use a pocket computer (palm)
  • Able to give informed consent
  • Affiliated to social insurance

排除标准

  • Past medical history of stroke
  • Diamox® injection contraindication
  • History of major depression
  • Severe visual deficiency
  • Contra-indication to brain MRI
  • Contra-indication to HMPAO
  • Contra-indication to Acetazolamide
  • Patient under safeguard of justice
  • For women, ineffective contraceptive method
  • Breast-feeding or Pregnant women

结局指标

主要结局

the extent of white matter vascular lesions (leuko encephalopathy) and impairment in executive functions

时间窗: Day 0

次要结局

  • cognitive parameters and the degree of brain atrophy(at 6 months)
  • cognitive parameters and the number of small deep infarct(after the follow-up (6 months))
  • cognitive parameters and the basal cerebral blood flow and the cerebrovascular reserve capacity.(after the follow-up (6 months))
  • impairment in executive functions and the extent of white matter vascular lesions (leuko encephalopathy)(at 6 month (end of follow-up))

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (4)

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