- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00704327
Evaluating the Impact of Cerebral Ischemic And Degenerative Changes On Cognition
Обзор исследования
Статус
Подробное описание
Preliminary evidence indicates that intracranial atherosclerosis may predict incident cerebrovascular events and central atrophy. Age induced changes on cerebral tissue in adulthood is witnessed as atrophy and well know ischemic changes on imaging studies. There is no consensus at this time what constitutes normal, age induced atrophy and pathologic atrophy on imaging studies. The same challenge is also encountered for ischemic cerebral parenchymal change.
Until recently there have been several important limitations in this research 1) Measurement of cerebral tissue loss and amount of ischemic insult was based on a qualitative grading (2) There was no cognitive testing. With Advancements in software technology that have now allowed for measurements of CSF and brain volumes in reliable and reproducible ways and the neuroradiologist having access to the subject's Neurological Cognitive Testing Scores, this study will objectively measure MRI findings and correlate them with the level of cognitive function.
This study will look at subjects who have undergone cognitive testing from the Neurology Clinic and then referred for an MRI brain exam, as standard of care testing. The MRI information will be acquired by volumetric technique for calculation of brain and CSF volumes and MRI data will be plotted against the cognitive test results.
The results of this study will be to correlate quantitative measures of cerebral atrophic and ischemic changes with level of cognition and to establish reliable imaging criteria that can help identify normal, age induced versus pathologic. Information obtained will shed light to cognitive effects and imaging appearance of: Separation of normal age related changes from pathologic states, changes leading to dementia and normal pressure hydrocephalus.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
-
-
Massachusetts
-
Burlington, Massachusetts, Соединенные Штаты, 01805
- Lahey Clinic, Inc.
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Subjects older than 50 years of age
- Subjects who have undergone Cognitive Testing
- Subjects who can cooperate and give informed consent
Exclusion Criteria:
- Subjects with known medical conditions predisposing them for atrophy such as: Chronic renal failure, HIV, head/neck tumors, prior radiation, post- traumatic brain disorder, metabolic disorders of brain, polysubstance abuse, and steroid use
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: Только для случая
- Временные перспективы: Поперечный разрез
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
Correlate quantitative measures of cerebral atrophic and ischemic changes with level of cognition using Mental Status Exam and Brain MRI exam
Временное ограничение: One time visit, duration of MRI
|
One time visit, duration of MRI
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
Establish reliable imaging criteria to identify normal age induced changes versus pathologic process comparing Mental Status Exam with Brain MRI(measuring CSF and Brain volumes)
Временное ограничение: Duration of study 3 years
|
Duration of study 3 years
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Sami H. Erbay, M.D., Lahey Clinic, Inc.
Публикации и полезные ссылки
Общие публикации
- Ylikoski A, Erkinjuntti T, Raininko R, Sarna S, Sulkava R, Tilvis R. White matter hyperintensities on MRI in the neurologically nondiseased elderly. Analysis of cohorts of consecutive subjects aged 55 to 85 years living at home. Stroke. 1995 Jul;26(7):1171-7. doi: 10.1161/01.str.26.7.1171.
- Kamata T, Hishida A, Takita T, Sawada K, Ikegaya N, Maruyama Y, Miyajima H, Kaneko E. Morphologic abnormalities in the brain of chronically hemodialyzed patients without cerebrovascular disease. Am J Nephrol. 2000 Jan-Feb;20(1):27-31. doi: 10.1159/000013551.
- Muuronen A, Bergman H, Hindmarsh T, Telakivi T. Influence of improved drinking habits on brain atrophy and cognitive performance in alcoholic patients: a 5-year follow-up study. Alcohol Clin Exp Res. 1989 Feb;13(1):137-41. doi: 10.1111/j.1530-0277.1989.tb00298.x.
- National Heart, Lung, and Blood Institute(NHLBI), National Institutes of Health. Morbidity and mortality: 2000 chart book on cardiovascular, lung and blood disease. Abailable at: http://www.nhlbi.nih.gov/resources/docs/00chtbk.pdf. Accessed February 13, 2002
- Knopman DS, Mosley TH, Catellier DJ, Sharrett AR; Atherosclerosis Risk in Communities (ARIC) Study. Cardiovascular risk factors and cerebral atrophy in a middle-aged cohort. Neurology. 2005 Sep 27;65(6):876-81. doi: 10.1212/01.wnl.0000176074.09733.a8.
- Rumberger JA, Simons DB, Fitzpatrick LA, Sheedy PF, Schwartz RS. Coronary artery calcium area by electron-beam computed tomography and coronary atherosclerotic plaque area. A histopathologic correlative study. Circulation. 1995 Oct 15;92(8):2157-62. doi: 10.1161/01.cir.92.8.2157.
- Arad Y, Spadaro LA, Goodman K, Lledo-Perez A, Sherman S, Lerner G, Guerci AD. Predictive value of electron beam computed tomography of the coronary arteries. 19-month follow-up of 1173 asymptomatic subjects. Circulation. 1996 Jun 1;93(11):1951-3. doi: 10.1161/01.cir.93.11.1951.
- Arad Y, Spadaro LA, Goodman K, Newstein D, Guerci AD. Prediction of coronary events with electron beam computed tomography. J Am Coll Cardiol. 2000 Oct;36(4):1253-60. doi: 10.1016/s0735-1097(00)00872-x.
- Wong ND, Hsu JC, Detrano RC, Diamond G, Eisenberg H, Gardin JM. Coronary artery calcium evaluation by electron beam computed tomography and its relation to new cardiovascular events. Am J Cardiol. 2000 Sep 1;86(5):495-8. doi: 10.1016/s0002-9149(00)01000-6.
- Raggi P, Callister TQ, Cooil B, He ZX, Lippolis NJ, Russo DJ, Zelinger A, Mahmarian JJ. Identification of patients at increased risk of first unheralded acute myocardial infarction by electron-beam computed tomography. Circulation. 2000 Feb 29;101(8):850-5. doi: 10.1161/01.cir.101.8.850.
- Simon A, Giral P, Levenson J. Extracoronary atherosclerotic plaque at multiple sites and total coronary calcification deposit in asymptomatic men. Association with coronary risk profile. Circulation. 1995 Sep 15;92(6):1414-21. doi: 10.1161/01.cir.92.6.1414.
- Erbay S, Han R, Baccei S, Krakov W, Zou KH, Bhadelia R, Polak J. Intracranial carotid artery calcification on head CT and its association with ischemic changes on brain MRI in patients presenting with stroke-like symptoms: retrospective analysis. Neuroradiology. 2007 Jan;49(1):27-33. doi: 10.1007/s00234-006-0159-z. Epub 2006 Nov 7.
- Babiarz LS, Yousem DM, Bilker W, Wasserman BA. Middle cerebral artery infarction: relationship of cavernous carotid artery calcification. AJNR Am J Neuroradiol. 2005 Jun-Jul;26(6):1505-11.
- Yue NC, Arnold AM, Longstreth WT Jr, Elster AD, Jungreis CA, O'Leary DH, Poirier VC, Bryan RN. Sulcal, ventricular, and white matter changes at MR imaging in the aging brain: data from the cardiovascular health study. Radiology. 1997 Jan;202(1):33-9. doi: 10.1148/radiology.202.1.8988189.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2008-029
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .