An interventional study of Cardiac surgery in Coronary Artery Disease, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-09.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Basic science
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 155 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This arm will include patients older than 18 years and candidate to cardiac surgery.
Procedure: Cardiac surgery
Patients older than 18 years who undergo coronary angiogram. This arm will include patients with coronary revascularization and patients without coronary revascularization.
A study-certified cardiothoracic surgeon must deem a patient, who otherwise fulfills all inclusion and exclusion criteria for any cardiac surgery (conventional, off-pump cardiac surgery). The procedure must be performed as soon as possible.
Compare cognitive disorders using the scale Dementia rating scale (DRS) of Mattis in 2 groups
Time frame: Before intervention and 12 month after intervention
Blood biomarkers: inflammation, coagulation, protein
Time frame: 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
Time frame: 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
Time frame: Before intervention, 3 weeks (no biology), 6 months (no MRI and biology) and 12 month after intervention (no biology)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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University Hospital, Lille