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

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946959
• Other study ID #: 2007_0724
• Secondary ID: 2007-A1420-53
• Status: Completed
• Phase: N/A
• First received: July 24, 2009
• Last updated: November 8, 2016
• Start date: June 2008
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cognition Disorders
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Cardiologique, CHRU de Lille	Lille	Nord-Pas-de-Calais

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare cognitive disorders using the scale Dementia rating scale (DRS) of Mattis in 2 groups		Before intervention and 12 month after intervention	No
Secondary	Blood biomarkers: inflammation, coagulation, protein		Before intervention, 3 weeks (no biology), 6 months (no MRI and biology) and 12 month after intervention (no biology)	No
Secondary	Neuropsychological evaluation: global cognitive function using MMSE, memory, attention		Before intervention, 3 weeks (no biology), 6 months (no MRI and biology) and 12 month after intervention (no biology)	No
Secondary	Imaging parameters (MRI): abnormalities of white matter, ischemic lesions, hippocampus volume		Before intervention, 3 weeks (no biology), 6 months (no MRI and biology) and 12 month after intervention (no biology)	No