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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT00946959
Study type Interventional
Source University Hospital, Lille
Contact
Status Completed
Phase N/A
Start date June 2008
Completion date June 2016

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