Characterization of Factors Influencing the Cognitive Decline in Patients With Coronary Artery Disease
- Conditions
- Coronary Artery Disease
- Interventions
- Procedure: Cardiac surgery
- Registration Number
- NCT00946959
- Lead Sponsor
- University Hospital, Lille
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
- aged more than 18 years,
- candidate to cardiac surgery or patients candidate to coronary angioplasty.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cardiac surgery Cardiac surgery This arm will include patients older than 18 years and candidate to cardiac surgery.
- Primary Outcome Measures
Name Time Method Compare cognitive disorders using the scale Dementia rating scale (DRS) of Mattis in 2 groups Before intervention and 12 month after intervention
- Secondary Outcome Measures
Name Time Method Blood biomarkers: inflammation, coagulation, protein Before intervention, 3 weeks (no biology), 6 months (no MRI and biology) and 12 month after intervention (no biology) Imaging parameters (MRI): abnormalities of white matter, ischemic lesions, hippocampus volume Before intervention, 3 weeks (no biology), 6 months (no MRI and biology) and 12 month after intervention (no biology) Neuropsychological evaluation: global cognitive function using MMSE, memory, attention Before intervention, 3 weeks (no biology), 6 months (no MRI and biology) and 12 month after intervention (no biology)
Trial Locations
- Locations (1)
Hôpital Cardiologique, CHRU de Lille
🇫🇷Lille, Nord-Pas-de-Calais, France