Determinants of Cognitive Impairment After Acute Coronary Syndrome

NCT00982176 | Completed

• 1 other identifier: CHUBX2007/31
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Syndrome

Keywords

Anatomo-functional determinants; cognitive impairment; coronary syndrome; brain MRI; cerebral perfusion scintigraphy

Outcome Measures

Primary Outcomes (1)

• the extent of white matter vascular lesions (leuko encephalopathy) and impairment in executive functions

  Day 0

Secondary Outcomes (4)

• 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)

Study Arms (1)

1

Other: Brain MRI and cerebral perfusion scintigraphy

Interventions

Brain MRI and cerebral perfusion scintigraphy OTHER

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.

1

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Male and female
• Age :30 to 65 years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Université Victor Segalen Bordeaux 2: collaborator

Study Sites (2)

CHU de Bordeaux

Bordeaux, 33076, France

Location

Hôpital Cardiologique du Haut-Lévêque (CEPTA)

Pessac, 33604, France

Location

MeSH Terms

Conditions

Angina, Unstable; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Igor SIBON, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2009
• First Posted: September 23, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: April 2, 2014

Record last verified: 2014-04

Locations

FR (2)