- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00982176
Determinants of Cognitive Impairment After Acute Coronary Syndrome (COSCA)
Anatomo-functional Determinants of Cognitive Impairment After Acute Coronary Syndrome: A Brain MRI and Cerebral Perfusion Scintigraphy Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Bordeaux, France, 33076
- CHU de Bordeaux
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Pessac, France, 33604
- Hôpital Cardiologique du Haut-Lévêque (CEPTA)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Past medical history of stroke
- Diamox® injection contraindication
- Dementia
- History of major depression
- Aphasia
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the extent of white matter vascular lesions (leuko encephalopathy) and impairment in executive functions
Time Frame: Day 0
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cognitive parameters and the degree of brain atrophy
Time Frame: at 6 months
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at 6 months
|
cognitive parameters and the number of small deep infarct
Time Frame: after the follow-up (6 months)
|
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)
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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)
|
at 6 month (end of follow-up)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Igor SIBON, MD, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX2007/31
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