Clinical trial NCT00946959: Characterization of Factors Influencing the Cognitive Decline in Patients With Coronary Artery Disease
Official title: Characterization of Factors Influencing the Occurrence of Cognitive Decline in Patients With Coronary Artery Disease and Undergoing Cardiac Surgery and Coronary Angioplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: cardiac surgery
angioplasty
cognitive decline
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2009-07-27
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The real impact of cardiac surgery and coronary angioplasty remains to be clarified and, where appropriate, the influencing factors in a way beneficial or deleterious remain to be identified.

The identification of such factors could make even faster screening, prevention and therefore open therapeutic prospects for those patients.

The objective of the study is to constitute a prospective cohort to assess the occurrence of cognitive decline after cardiac surgery (200 patients) and coronary angioplasty (200 patients) using the scale Dementia rating scale (DRS) of Mattis. In addition, the investigators will identify factors that influence positively or negatively, the occurrence of such a cognitive decline. The study based on a systematic monitoring of clinical, biological, imaging and pharmacological factors and, to correlate the respective influence of these factors on the incidence of cognitive decline.

Detailed description: Cardiovascular invasive interventions (surgery and angioplasty) save thousands of lives every year, but questions remain about the neurological complications and in particular cognitive deficit. Indeed, cardiac surgery has been associated with cognitive decline in 50 to 70% of patients in the first postoperative week and in 20 to 40% of patients 6 months to one year after surgery.

The study will be based on a prospective monitoring during 1 year of a cohort of 400 patients who will receive either a cardiac surgery or coronary angioplasty. At inclusion, will be collected medical history, risk factors, treatment history, clinical and etiological data (imaging, cardiac and vascular balance).

The results of routine tests performed complementary to hospitalization will be recorded (echo-doppler vessels of the neck, cardiac ultrasound trans-thoracic and/or transesophageal a holter cardiac).

In recruiting, we will apply a method of matching based on age (on 5 years) between 2 groups in order to compare 2 homogeneous groups.

Eligibility criteria: Inclusion Criteria:

* aged more than 18 years,
* candidate to cardiac surgery or patients candidate to coronary angioplasty.

Exclusion Criteria:

* presenting a psychiatric illness that can interfere with the mental state and with scores provided in this study (explored in a systematic manner by the Mini International Neuropsychiatric Interview DSM 4).

Primary outcomes:
measure: Compare cognitive disorders using the scale Dementia rating scale (DRS) of Mattis in 2 groups
timeFrame: Before intervention and 12 month after intervention
Secondary outcomes:
measure: Blood biomarkers: inflammation, coagulation, protein
timeFrame: Before intervention, 3 weeks (no biology), 6 months (no MRI and biology) and 12 month after intervention (no biology)
measure: Neuropsychological evaluation: global cognitive function using MMSE, memory, attention
timeFrame: Before intervention, 3 weeks (no biology), 6 months (no MRI and biology) and 12 month after intervention (no biology)
measure: Imaging parameters (MRI): abnormalities of white matter, ischemic lesions, hippocampus volume
timeFrame: Before intervention, 3 weeks (no biology), 6 months (no MRI and biology) and 12 month after intervention (no biology)
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Cardiologique, CHRU de Lille
state: Nord-Pas-de-Calais
Study officials:
affiliation: University Hospital, Lille
name: Thomas Modine, MD
role: PRINCIPAL_INVESTIGATOR
References: