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
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946959

Locations
France
University hospital
Lille, Nord-Pas-de-Calais, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Thomas Modine, MD University Hospital, Lille
  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 July 31, 2014