Determinants of Cognitive Impairment After Acute Coronary Syndrome (COSCA)
|ClinicalTrials.gov Identifier: NCT00982176|
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : April 2, 2014
|Condition or disease||Intervention/treatment|
|Coronary Syndrome||Other: Brain MRI and cerebral perfusion scintigraphy|
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.
Relationship between cognitive impairment and brain anatomo-functional abnormalities will be investigated using a linear regression model.
|Study Type :||Observational|
|Actual Enrollment :||49 participants|
|Official Title:||Anatomo-functional Determinants of Cognitive Impairment After Acute Coronary Syndrome: A Brain MRI and Cerebral Perfusion Scintigraphy Study|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||May 2013|
Other: Brain MRI and cerebral perfusion scintigraphy
A standard neuropsychological assessment will be performed by a neuropsychologist. The daily life experience study will be performed. Questions will be asked to the patients 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 second SPECT study will be performed after intravenous injection of acetazolamide.
- the extent of white matter vascular lesions (leuko encephalopathy) and impairment in executive functions [ Time Frame: Day 0 ]
- cognitive parameters and the degree of brain atrophy [ Time Frame: at 6 months ]
- cognitive parameters and the number of small deep infarct [ Time Frame: after the follow-up (6 months) ]
- cognitive parameters and the basal cerebral blood flow and the cerebrovascular reserve capacity. [ Time Frame: after the follow-up (6 months) ]
- impairment in executive functions and the extent of white matter vascular lesions (leuko encephalopathy) [ Time Frame: at 6 month (end of follow-up) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982176
|CHU de Bordeaux|
|Bordeaux, France, 33076|
|Hôpital Cardiologique du Haut-Lévêque (CEPTA)|
|Pessac, France, 33604|
|Principal Investigator:||Igor SIBON, MD||University Hospital, Bordeaux|