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

NCT00946959 | Completed

• 2 other identifiers: 2007_07242007-A1420-53
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

cardiac surgery; angioplasty; cognitive decline

Outcome Measures

Primary Outcomes (1)

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

  Before intervention and 12 month after intervention

Secondary Outcomes (3)

• Blood biomarkers: inflammation, coagulation, protein

  Before intervention, 3 weeks (no biology), 6 months (no MRI and biology) and 12 month after intervention (no biology)

• 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)

• 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)

Study Arms (2)

cardiac surgery

EXPERIMENTAL

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

Procedure: Cardiac surgery

cardiac angiography

NO INTERVENTION

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

Interventions

Cardiac surgery PROCEDURE

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.

cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged more than 18 years,
• candidate to cardiac surgery or patients candidate to coronary angioplasty.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Cardiologique, CHRU de Lille

Lille, Hauts-de-France, 59037, France

Location

MeSH Terms

Conditions

Coronary Artery Disease; Cognitive Dysfunction

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Thomas Modine, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2009
• First Posted: July 27, 2009
• Study Start: June 1, 2008
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 9, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)