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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardiac surgery
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Coronary Artery Disease focused on measuring cardiac surgery, angioplasty, cognitive decline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hôpital Cardiologique, CHRU de Lille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cardiac surgery

cardiac angiography

Arm Description

This arm will include patients older than 18 years and candidate to cardiac surgery.

Patients older than 18 years who undergo coronary angiogram. This arm will include patients with coronary revascularization and patients without coronary revascularization.

Outcomes

Primary Outcome Measures

Compare cognitive disorders using the scale Dementia rating scale (DRS) of Mattis in 2 groups

Secondary Outcome Measures

Blood biomarkers: inflammation, coagulation, protein
Neuropsychological evaluation: global cognitive function using MMSE, memory, attention
Imaging parameters (MRI): abnormalities of white matter, ischemic lesions, hippocampus volume

Full Information

First Posted
July 24, 2009
Last Updated
November 8, 2016
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT00946959
Brief Title
Characterization of Factors Influencing the Cognitive Decline in Patients With Coronary Artery Disease
Acronym
COGCAR
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 Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
cardiac surgery, angioplasty, cognitive decline

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cardiac surgery
Arm Type
Experimental
Arm Description
This arm will include patients older than 18 years and candidate to cardiac surgery.
Arm Title
cardiac angiography
Arm Type
No Intervention
Arm Description
Patients older than 18 years who undergo coronary angiogram. This arm will include patients with coronary revascularization and patients without coronary revascularization.
Intervention Type
Procedure
Intervention Name(s)
Cardiac surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Modine, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Cardiologique, CHRU de Lille
City
Lille
State/Province
Nord-Pas-de-Calais
ZIP/Postal Code
59037
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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