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Determinants of Cognitive Impairment After Acute Coronary Syndrome (COSCA)

This study has been completed.
Sponsor:
Collaborator:
Université Victor Segalen Bordeaux 2
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00982176
First received: May 12, 2009
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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 Intervention
Coronary Syndrome
Other: Brain MRI and cerebral perfusion scintigraphy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • the extent of white matter vascular lesions (leuko encephalopathy) and impairment in executive functions [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cognitive parameters and the degree of brain atrophy [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • cognitive parameters and the number of small deep infarct [ Time Frame: after the follow-up (6 months) ] [ Designated as safety issue: No ]
  • cognitive parameters and the basal cerebral blood flow and the cerebrovascular reserve capacity. [ Time Frame: after the follow-up (6 months) ] [ Designated as safety issue: No ]
  • impairment in executive functions and the extent of white matter vascular lesions (leuko encephalopathy) [ Time Frame: at 6 month (end of follow-up) ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: September 2009
Study Completion Date: May 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982176

Locations
France
CHU de Bordeaux
Bordeaux, France, 33076
Hôpital Cardiologique du Haut-Lévêque (CEPTA)
Pessac, France, 33604
Sponsors and Collaborators
University Hospital, Bordeaux
Université Victor Segalen Bordeaux 2
Investigators
Principal Investigator: Igor SIBON, MD University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00982176     History of Changes
Other Study ID Numbers: CHUBX2007/31
Study First Received: May 12, 2009
Last Updated: April 1, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Anatomo-functional determinants
cognitive impairment
coronary syndrome
brain MRI
cerebral perfusion scintigraphy

Additional relevant MeSH terms:
Acute Coronary Syndrome
Cognition Disorders
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Delirium, Dementia, Amnestic, Cognitive Disorders
Disease
Heart Diseases
Mental Disorders
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014