StrokeNCT00391378
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
An observational study of Stroke and Cognitive Symptoms, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Between 1 and 5 percent of patients who have coronary artery bypass surgery suffer a stroke following surgery, and 30 percent have new brain lesions that do not produce symptoms and are seen only on MRI. In addition, up to 40 percent of patients develop long-term cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cognitive Symptoms
- How many people
- 363 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2006to 3 Jan 2011
- Phase
- Observational
- 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
- Age 18 years or greater
- Neurologically and cognitively independent prior to surgery (mRS less than 2)
- CABG, aortic or mitral valve replacement, or a combined valve/CABG procedure scheduled within one week
Who cannot join
- Planned concomitant carotid endarterectomy
- Concomitant medical disorders making clinical follow-up of at least 6 months unlikely or impossible (e.g., neoplastic disease, hepatic failure)
- History of dementia, cognitive dysfunction (MMSE score less than 24) or psychotic disorder
- Any current MRI contraindication (cardiac pacemaker or defibrillator, insulin pump, aneurysmal clip, implanted neural stimulator, cochlear implant, metal shrapnel or bullet, etc)
- Definite or possible pacemaker placement at the time of or after surgery
- Inability to give informed consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral Lesions and Outcomes After Cardiac Surgery (CLOCS)
Between 1 and 5 percent of patients who have coronary artery bypass surgery suffer a stroke following surgery, and 30 percent have new brain lesions that do not produce symptoms and are seen only on MRI. In addition, up to 40 percent of patients develop long-term cognitive impairment. This study will identify risk factors that predict whether a person undergoing heart surgery will develop cerebral infarcts after surgery. It will also identify operative and inflammatory factors that may alter the risk, and will evaluate whether the small lesions are associated with cognitive decline at 6 months.
People 18 years of age or older who will undergo coronary artery bypass surgery (CABG), heart valve replacement, or combined CABG and valve replacement procedure are eligible for this study. Candidates must have no neurological or cognitive impairment before surgery.
Read more
Participants will undergo standard medical and surgical treatment as determined by their physicians. In addition, they have the following procedures:
- Medical and neurological evaluation before surgery and 24 and 48 hours after surgery.
- Brain MRI before surgery, and 48 hours, 30 days and 6 months after surgery.
- Blood draws before surgery, immediately after surgery, and 6, 24, 48 and 72 hours after surgery to quantify the response of their inflammatory system to surgery.
- Neuropsychological examinations 30 days and 6 months after surgery.
- In addition, patients who agree to enroll in a substudy that will explore whether differences in the genes coding for inflammatory molecules lead to a change in the risk of iscjhemia after heart surgery, will have extra blood drawn for genetic analysis.
Read the detailed description
Objective. Cardiac surgery is the leading cause of iatrogenic stroke in the United States; 1% to 5% of patients undergoing CABG have a stroke, and 30% have clinically silent new lesions that are detectable only on MRI. Cognitive dysfunction is also common after heart surgery, and up to 40% have long-term cognitive impairment. The primary objective of this study is to define the pre-operative risk profile that best predicts postoperative ischemic or cognitive changes in patients undergoing heart surgery and to 1) establish a registry of patients undergoing cardiac surgery to evaluate the relationship of new lesions on MRI, blood biomarkers, neurological and neurocognitive outcome 2) identify the most significant risk factors for post operative cerebral ischemic lesions 3) determine whether new ischemic lesions on DWI are associated with subsequent neurological or cognitive impairment. The objective of the genetics sub-study is to estimate the relative risk of specific polymorphisms of genes of molecules involved in the inflammatory response and occurrence of new ischemic lesions.
Study population. 363 patients (188 consecutive patients undergoing CABG and 175 patients undergoing aortic or mitral valve replacement).
Design. Patients will have a pre-operative medical and neurological evaluation before surgery and 24 and 48 hours after surgery. A brain MRI will be obtained preoperatively and 48 hours, 30 days, and 6 months after surgery. Blood drawn to quantify biomarkers will be obtained before and immediately after surgery and 6, 24, 48 and 72 hours post-operatively. Patients enrolled in the genetics sub-study will have additional blood drawn for sequencing of inflammatory genes. Neuropsychological examinations will occur at 30 days and 6 months after surgery.
Outcome measures. The primary outcome measure is the evidence of new ischemic lesions on the 48-hour DWI relative to pre-operative DWI. In addition, the following outcome measures will be considered in exploratory analyses: 1) Any new ischemic lesion on 30 day DWI or FLAIR relative to pre-op DWI or FLAIR; 2) Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (if protocol-required scans are not obtained) occurring within the first 30 days (plus or minus 3 days) after surgery; 3) All cause mortality; 4) Encephalopathy; 5) Cognitive decline at 30 days; 6) Cognitive decline at 6 months; 7) Evidence of reperfusion injury on 48-hour post-gadolinium FLAIR; 8) New ischemic lesions on 6-month DWI or FLAIR; 9) Changes in values of blood markers; 10) Number, volume, and location of new DWI or FLAIR lesions.
- Conditions
- Stroke, Cognitive Symptoms
- Keywords
- Diffusion-Weighted Magnetic Resonance Imaging, MRI (Magnetic Resonance Imaging), Stroke, Cognition, Heart
- Medical subject headings
- Stroke, Neurobehavioral Manifestations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2006 (estimated)
- Study start9 Sep 2006
- Study completion3 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The 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
- Observational
- Time perspective
- Other
- Enrolment
- 363 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391378
- Sponsor's protocol ID
- 999906245
- Other IDs
- 06-N-N245
- Status last verified
- 3 Jan 2011
- First submitted
- 21 Oct 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Selnes OA, Goldsborough MA, Borowicz LM, McKhann GM. Neurobehavioural sequelae of cardiopulmonary bypass. Lancet. 1999 May 8;353(9164):1601-6. doi: 10.1016/S0140-6736(98)07576-X.
PubMed 10334272Stamou SC, Hill PC, Dangas G, Pfister AJ, Boyce SW, Dullum MK, Bafi AS, Corso PJ. Stroke after coronary artery bypass: incidence, predictors, and clinical outcome. Stroke. 2001 Jul;32(7):1508-13. doi: 10.1161/01.str.32.7.1508.
PubMed 11441193Breuer AC, Furlan AJ, Hanson MR, Lederman RJ, Loop FD, Cosgrove DM, Greenstreet RL, Estafanous FG. Central nervous system complications of coronary artery bypass graft surgery: prospective analysis of 421 patients. Stroke. 1983 Sep-Oct;14(5):682-7. doi: 10.1161/01.str.14.5.682.
PubMed 6606871
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Lesions and Outcomes After Cardiac Surgery (CLOCS)
- ClinicalTrials.gov ID
- NCT00391378
- Acronym / sponsor ID
- 999906245
- Conditions
- Stroke, Cognitive Symptoms
- Keywords
- Diffusion-Weighted Magnetic Resonance Imaging, MRI (Magnetic Resonance Imaging), Stroke, Cognition, Heart
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 363 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 9 Sep 2006
- Study completion
- 3 Jan 2011
- First posted
- 24 Oct 2006 (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.
Between 1 and 5 percent of patients who have coronary artery bypass surgery suffer a stroke following surgery, and 30 percent have new brain lesions that do not produce symptoms and are seen only on MRI. In addition, up to 40 percent of patients develop long-term cognitive impairment. This study will identify risk factors that predict whether a person undergoing heart surgery will develop cerebral infarcts after surgery. It will also identify operative and inflammatory factors that may alter the risk, and will evaluate whether the small lesions are associated with cognitive decline at 6 months.
People 18 years of age or older who will undergo coronary artery bypass surgery (CABG), heart valve replacement, or combined CABG and valve replacement procedure are eligible for this study. Candidates must have no neurological or cognitive impairment before surgery.
Participants will undergo standard medical and surgical treatment as determined by their physicians. In addition, they have the following procedures:
- Medical and neurological evaluation before surgery and 24 and 48 hours after surgery.
- Brain MRI before surgery, and 48 hours, 30 days and 6 months after surgery.
- Blood draws before surgery, immediately after surgery, and 6, 24, 48 and 72 hours after surgery to quantify the response of their inflammatory system to surgery.
- Neuropsychological examinations 30 days and 6 months after surgery.
- In addition, patients who agree to enroll in a substudy that will explore whether differences in the genes coding for inflammatory molecules lead to a change in the risk of iscjhemia after heart surgery, will have extra blood drawn for genetic analysis.
Detailed description
Objective. Cardiac surgery is the leading cause of iatrogenic stroke in the United States; 1% to 5% of patients undergoing CABG have a stroke, and 30% have clinically silent new lesions that are detectable only on MRI. Cognitive dysfunction is also common after heart surgery, and up to 40% have long-term cognitive impairment. The primary objective of this study is to define the pre-operative risk profile that best predicts postoperative ischemic or cognitive changes in patients undergoing heart surgery and to 1) establish a registry of patients undergoing cardiac surgery to evaluate the relationship of new lesions on MRI, blood biomarkers, neurological and neurocognitive outcome 2) identify the most significant risk factors for post operative cerebral ischemic lesions 3) determine whether new ischemic lesions on DWI are associated with subsequent neurological or cognitive impairment. The objective of the genetics sub-study is to estimate the relative risk of specific polymorphisms of genes of molecules involved in the inflammatory response and occurrence of new ischemic lesions.
Study population. 363 patients (188 consecutive patients undergoing CABG and 175 patients undergoing aortic or mitral valve replacement).
Design. Patients will have a pre-operative medical and neurological evaluation before surgery and 24 and 48 hours after surgery. A brain MRI will be obtained preoperatively and 48 hours, 30 days, and 6 months after surgery. Blood drawn to quantify biomarkers will be obtained before and immediately after surgery and 6, 24, 48 and 72 hours post-operatively. Patients enrolled in the genetics sub-study will have additional blood drawn for sequencing of inflammatory genes. Neuropsychological examinations will occur at 30 days and 6 months after surgery.
Outcome measures. The primary outcome measure is the evidence of new ischemic lesions on the 48-hour DWI relative to pre-operative DWI. In addition, the following outcome measures will be considered in exploratory analyses: 1) Any new ischemic lesion on 30 day DWI or FLAIR relative to pre-op DWI or FLAIR; 2) Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (if protocol-required scans are not obtained) occurring within the first 30 days (plus or minus 3 days) after surgery; 3) All cause mortality; 4) Encephalopathy; 5) Cognitive decline at 30 days; 6) Cognitive decline at 6 months; 7) Evidence of reperfusion injury on 48-hour post-gadolinium FLAIR; 8) New ischemic lesions on 6-month DWI or FLAIR; 9) Changes in values of blood markers; 10) Number, volume, and location of new DWI or FLAIR lesions.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or greater
- Neurologically and cognitively independent prior to surgery (mRS less than 2)
- CABG, aortic or mitral valve replacement, or a combined valve/CABG procedure scheduled within one week
Key exclusion criteria (7 listed)
- Planned concomitant carotid endarterectomy
- Concomitant medical disorders making clinical follow-up of at least 6 months unlikely or impossible (e.g., neoplastic disease, hepatic failure)
- History of dementia, cognitive dysfunction (MMSE score less than 24) or psychotic disorder
- Any current MRI contraindication (cardiac pacemaker or defibrillator, insulin pump, aneurysmal clip, implanted neural stimulator, cochlear implant, metal shrapnel or bullet, etc)
- Definite or possible pacemaker placement at the time of or after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 10334272Selnes OA, Goldsborough MA, Borowicz LM, McKhann GM. Neurobehavioural sequelae of cardiopulmonary bypass. Lancet. 1999 May 8;353(9164):1601-6. doi: 10.1016/S0140-6736(98)07576-X.
- Background: PubMed 11441193Stamou SC, Hill PC, Dangas G, Pfister AJ, Boyce SW, Dullum MK, Bafi AS, Corso PJ. Stroke after coronary artery bypass: incidence, predictors, and clinical outcome. Stroke. 2001 Jul;32(7):1508-13. doi: 10.1161/01.str.32.7.1508.
- Background: PubMed 6606871Breuer AC, Furlan AJ, Hanson MR, Lederman RJ, Loop FD, Cosgrove DM, Greenstreet RL, Estafanous FG. Central nervous system complications of coronary artery bypass graft surgery: prospective analysis of 421 patients. Stroke. 1983 Sep-Oct;14(5):682-7. doi: 10.1161/01.str.14.5.682.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Cognitive Symptoms, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
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 3 inclusion and 7 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 2 Jul 2017. 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00391378, which also lists 3 linked publications.
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 2 Jul 2017.