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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT00946959
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

July 24, 2009
July 24, 2009
June 2008
June 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Characterization of Factors Influencing the Cognitive Decline in Patients With Coronary Artery Disease
Characterization of Factors Influencing the Occurrence of Cognitive Decline in Patients With Coronary Artery Disease and Undergoing Cardiac Surgery and Coronary Angioplasty

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Coronary Artery Disease
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.
  • Experimental: cardiac surgery
    This arm will include patients older than 18 years and candidate to cardiac surgery.
    Intervention: Procedure: Cardiac surgery
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
400
June 2011
June 2010   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00946959
2007-A1420-53, CPP 08/10
No
Régis FIEVE, University Hospital, Lille
University Hospital, Lille
Not Provided
Principal Investigator: Thomas Modine, MD University Hospital, Lille
University Hospital, Lille
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP