Coronary SyndromeCOSCANCT00982176
Determinants of Cognitive Impairment After Acute Coronary Syndrome
A study testing Brain MRI and cerebral perfusion scintigraphy in people with Coronary Syndrome, run by University Hospital, Bordeaux at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Coronary Syndrome
- What is being tested?
- Brain MRI and cerebral perfusion scintigraphy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2009to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Past medical history of stroke
- Diamox® injection contraindication
- Dementia
- History of major depression
- Aphasia
- Severe visual deficiency
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Bordeaux
Bordeaux, 33076
Hôpital Cardiologique du Haut-Lévêque (CEPTA)
Pessac, 33604
About this study
Official title: Anatomo-functional Determinants of Cognitive Impairment After Acute Coronary Syndrome: A Brain MRI and Cerebral Perfusion Scintigraphy Study
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.
Read the 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.
- Conditions
- Coronary Syndrome
- Being tested
- Brain MRI and cerebral perfusion scintigraphy
- Keywords
- Anatomo-functional determinants, cognitive impairment, coronary syndrome, brain MRI, cerebral perfusion scintigraphy
- Medical subject headings
- Angina, Unstable, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRI and cerebral perfusion scintigraphyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: Brain MRI and cerebral perfusion scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the extent of white matter vascular lesions (leuko encephalopathy) and impairment in executive functions
Measured: Day 0
Secondary outcomes (4)
cognitive parameters and the degree of brain atrophy
Measured: at 6 months
cognitive parameters and the number of small deep infarct
Measured: after the follow-up (6 months)
cognitive parameters and the basal cerebral blood flow and the cerebrovascular reserve capacity.
Measured: after the follow-up (6 months)
impairment in executive functions and the extent of white matter vascular lesions (leuko encephalopathy)
Measured: at 6 month (end of follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Université Victor Segalen Bordeaux 2
- Responsible party
- Sponsor
- Investigators
- Igor SIBON, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982176
- Sponsor's protocol ID
- CHUBX2007/31
- Other IDs
- 2008-A00906-49
- Acronym
- COSCA
- Status last verified
- Apr 2014
- First submitted
- 12 May 2009
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Bernard C, Catheline G, Dilharreguy B, Couffinhal T, Ledure S, Lassalle-Lagadec S, Callaert D, Allard M, Sibon I. Cerebral changes and cognitive impairment after an ischemic heart disease: a multimodal MRI study. Brain Imaging Behav. 2016 Sep;10(3):893-900. doi: 10.1007/s11682-015-9483-4.
PubMed 26589710
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomo-functional Determinants of Cognitive Impairment After Acute Coronary Syndrome: A Brain MRI and Cerebral Perfusion Scintigraphy Study
- ClinicalTrials.gov ID
- NCT00982176
- Acronym / sponsor ID
- COSCA / CHUBX2007/31
- Conditions
- Coronary Syndrome
- Keywords
- Anatomo-functional determinants, cognitive impairment, coronary syndrome, brain MRI, cerebral perfusion scintigraphy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Université Victor Segalen Bordeaux 2
- Study start
- Sep 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Brain MRI and cerebral perfusion scintigraphy |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (12 listed)
- Past medical history of stroke
- Diamox® injection contraindication
- Dementia
- History of major depression
- Aphasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain MRI and cerebral perfusion scintigraphyA 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. | Other | 1 |
Primary outcome
the extent of white matter vascular lesions (leuko encephalopathy) and impairment in executive functions
Time frame: Day 0
4 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Results publication: PubMed 26589710Bernard C, Catheline G, Dilharreguy B, Couffinhal T, Ledure S, Lassalle-Lagadec S, Callaert D, Allard M, Sibon I. Cerebral changes and cognitive impairment after an ischemic heart disease: a multimodal MRI study. Brain Imaging Behav. 2016 Sep;10(3):893-900. doi: 10.1007/s11682-015-9483-4.
Related trials for Coronary Syndrome
Recruiting
Randomized Prospective Trial on the Cost-Effectiveness of Photon-Counting CT Versus Energy-Integrating Detector CT in Suspected Chronic Coronary Syndrome
Computed Tomography Angiography, Coronary Artery Disease
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor SIBON, MD principal investigator
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain MRI and cerebral perfusion scintigraphy in people with Coronary Syndrome, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the extent of white matter vascular lesions (leuko encephalopathy) and impairment in executive functions (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00982176, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.