COSCA: Determinants of Cognitive Impairment After Acute Coronary Syndrome

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT00982176

Collaborator

Université Victor Segalen Bordeaux 2 (Other)

Enrollment

Locations

Duration (Months)

24.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Syndrome	Other: Brain MRI and cerebral perfusion scintigraphy

Detailed Description

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 Design

Study Type:

Observational

Actual Enrollment :

49 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
1	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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

the extent of white matter vascular lesions (leuko encephalopathy) and impairment in executive functions [Day 0]

Secondary Outcome Measures

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)]