Coronary Artery DiseaseCOGCARNCT00946959
Characterization of Factors Influencing the Cognitive Decline in Patients With Coronary Artery Disease
A study testing Cardiac surgery in people with Coronary Artery Disease, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cardiac surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged more than 18 years,
- candidate to cardiac surgery or patients candidate to coronary angioplasty.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Cardiologique, CHRU de Lille
Lille, Hauts-de-France, 59037
About this study
Official title: Characterization of Factors Influencing the Occurrence of Cognitive Decline in Patients With Coronary Artery Disease and Undergoing Cardiac Surgery and Coronary Angioplasty
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Cardiac surgery
- Keywords
- cardiac surgery, angioplasty, cognitive decline
- Medical subject headings
- Coronary Artery Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| cardiac surgery | Experimental | This arm will include patients older than 18 years and candidate to cardiac surgery. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare cognitive disorders using the scale Dementia rating scale (DRS) of Mattis in 2 groups
Measured: Before intervention and 12 month after intervention
Secondary outcomes (3)
Blood biomarkers: inflammation, coagulation, protein
Measured: 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
Measured: 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
Measured: Before intervention, 3 weeks (no biology), 6 months (no MRI and biology) and 12 month after intervention (no biology)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startJun 2008
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Modine, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946959
- Sponsor's protocol ID
- 2007_0724
- Other IDs
- 2007-A1420-53
- Acronym
- COGCAR
- Status last verified
- Nov 2016
- First submitted
- 24 Jul 2009
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Factors Influencing the Occurrence of Cognitive Decline in Patients With Coronary Artery Disease and Undergoing Cardiac Surgery and Coronary Angioplasty
- ClinicalTrials.gov ID
- NCT00946959
- Acronym / sponsor ID
- COGCAR / 2007_0724
- Conditions
- Coronary Artery Disease
- Keywords
- cardiac surgery, angioplasty, cognitive decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cardiac surgery | Experimental | Procedure: Cardiac surgeryThis arm will include patients older than 18 years and candidate to 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged more than 18 years,
- candidate to cardiac surgery or patients candidate to coronary angioplasty.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgeryA 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. | Procedure or surgery | cardiac surgery |
Primary outcome
Compare cognitive disorders using the scale Dementia rating scale (DRS) of Mattis in 2 groups
Time frame: Before intervention and 12 month after intervention
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Modine, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac surgery in people with Coronary Artery Disease, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare cognitive disorders using the scale Dementia rating scale (DRS) of Mattis in 2 groups (time frame: Before intervention and 12 month after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2016.