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Characterization of Factors Influencing the Cognitive Decline in Patients With Coronary Artery Disease (COGCAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00946959
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : November 9, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Cardiac surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2008
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Compare cognitive disorders using the scale Dementia rating scale (DRS) of Mattis in 2 groups [ Time Frame: Before intervention and 12 month after intervention ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00946959

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Hôpital Cardiologique, CHRU de Lille
Lille, Nord-Pas-de-Calais, France, 59037
Sponsors and Collaborators
University Hospital, Lille
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Principal Investigator: Thomas Modine, MD University Hospital, Lille

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Responsible Party: University Hospital, Lille Identifier: NCT00946959     History of Changes
Other Study ID Numbers: 2007_0724
2007-A1420-53 ( Other Identifier: ID-RCB Number, ANSM )
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Lille:
cardiac surgery
cognitive decline

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cognitive Dysfunction
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders