Characterization of Factors Influencing the Cognitive Decline in Patients With Coronary Artery Disease (COGCAR)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Coronary Artery Disease |
Procedure: Cardiac surgery |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Characterization of Factors Influencing the Occurrence of Cognitive Decline in Patients With Coronary Artery Disease and Undergoing Cardiac Surgery and Coronary Angioplasty |
- Compare cognitive disorders using the scale Dementia rating scale (DRS) of Mattis in 2 groups [ Time Frame: Before intervention and 12 month after intervention ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: cardiac surgery
This arm will include patients older than 18 years and candidate to cardiac surgery.
|
Procedure: Cardiac surgery
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.
|
|
No Intervention: cardiac angiography
Patients older than 18 years who undergo coronary angiogram. This arm will include patients with coronary revascularization and patients without coronary revascularization.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations More Information
No publications provided
| Responsible Party: | Régis FIEVE, University Hospital, Lille |
| ClinicalTrials.gov Identifier: | NCT00946959 History of Changes |
| Other Study ID Numbers: | 2007-A1420-53, CPP 08/10 |
| Study First Received: | July 24, 2009 |
| Last Updated: | July 24, 2009 |
| Health Authority: | France: Direction Générale de la Santé |
Keywords provided by University Hospital, Lille:
|
cardiac surgery angioplasty cognitive decline |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Cognition Disorders Heart Diseases Cardiovascular Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013