Determinants of Cognitive Impairment After Acute Coronary Syndrome (COSCA)

June 5, 2026 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • CHU de Bordeaux
      • Pessac, France, 33604
        • Hôpital Cardiologique du Haut-Lévêque (CEPTA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

a cohort of patients admitted for evaluation of their cardio-vascular risk factor 4 ±1 months after an acute coronary syndrome

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

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
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)
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

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Université Victor Segalen Bordeaux 2

Investigators

  • Principal Investigator: Igor SIBON, MD, University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 12, 2009

First Submitted That Met QC Criteria

September 22, 2009

First Posted (Estimated)

September 23, 2009

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX2007/31
  • 2008-A00906-49 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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