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Completed

NCT Number: NCT00946959

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Coronary Disease Heart Diseases Mental Disorders Myocardial Ischemia Neurocognitive Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Cardiologique, CHRU de Lille

Lille, Hauts-de-France, 59037, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Characterization of Factors Influencing the Occurrence of Cognitive Decline in Patients With Coronary Artery Disease and Undergoing Cardiac Surgery and Coronary Angioplasty

Acronym: COGCAR

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Jul 27, 2009
Registry last updated
Nov 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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