Comparison of the Risk of Stroke With On- Versus Off-Pump Coronary Artery Bypass Grafting
|First Received Date ICMJE||September 27, 2002|
|Last Updated Date||March 5, 2008|
|Start Date ICMJE||September 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00046410 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Comparison of the Risk of Stroke With On- Versus Off-Pump Coronary Artery Bypass Grafting|
|Official Title ICMJE||Assessing the Risk of New Ischemic Brain Lesions With On- Versus Off-Pump Coronary Artery Bypass Grafting|
This study will compare the safety of coronary artery bypass grafting (CABG) with and without the use of heart-lung bypass during surgery (on- versus off-pump surgery). CABG carries a risk of stroke and of cognition problems (problems with thought processes) that may be caused by small strokes. This study will use magnetic resonance imaging (MRI) to determine whether the newer technique of off-pump CABG carries a lower risk of stroke than on-pump CABG. The study will also evaluate the relative risk (the risk of stroke in CABG patients exposed to the following factors compared to CABG patients who are not exposed to the following factors) of other factors for stroke and cognitive problems, such as atherosclerosis (hardening of the arteries), age, sex, pre-surgery intellectual function and performance, previous stroke, chronic kidney failure, diabetes, high blood pressure, carotid artery disease (narrowing of the neck arteries to the brain), peripheral blood vessel disease, and micro embolism (tiny blood clots that travel to the brain).
Patients 18 years of age and older with chest pain or narrowing of the coronary arteries who are scheduled to undergo CABG surgery may be eligible for this study.
Participants will be randomly assigned to have CABG either on-pump or off-pump. They will undergo the following tests and procedures:
MRI is a diagnostic test that uses a strong magnetic field and radio waves to show structural and chemical changes in tissue. For the procedure, the patient lies on a table that slides into the scanner-a metal cylinder surrounded by a magnetic field. Earplugs are worn to muffle the loud knocking sounds that occur when the pictures are being taken. The scan, taken before surgery, will last about 20 minutes; the two after surgery take about 10 minutes to perform.
Objective - Off-pump coronary artery bypass grafting (CABG) is hypothesized to be a safer alternative to conventional on-pump CABG, but the comparative risks and benefits of the procedures for neurological outcomes have not been established by prospective randomized testing. The primary objective of this study is to assess the difference in frequency of new ischemic brain lesions in patients randomized to either on- or off-pump CABG. We will test the hypothesis that off-pump CABG is associated with a smaller proportion of patients with new lesions on MRI post-operatively. Secondary objectives will explore the relationship of other imaging markers, blood markers, and results of cognitive testing to the occurrence of new ischemic lesions, and estimate the relative risk of pre-operative factors. We will also conduct an observational substudy of non-randomized heart surgery patients acquiring complementary data to estimate the relative risk of pre-operative and operative factors for the occurrence of new ischemic lesions.
Study population - A total of 140 patients (70 per each group) will be randomized. Subjects will be neurologically independent adult patients undergoing non-emergency CABG who are appropriate for either on- or off-pump surgery. In the observational study we will also assemble a cohort of 100 consecutive patients that will have CABG and 100 consecutive patients that will have valve replacement surgery. Total accrual across both studies will be 340 patients.
Design - The study has a prospective randomized single blinded design. Patients will be randomized to on- or off-pump surgical technique if they meet all eligibility criteria. Analyses will be performed blinded to the surgical group assignment and based on intention-to-treat principle. MRI evaluation will be performed prior to surgery, 48 hours after surgery, 30 days and 6 months after surgery. Biomarkers will be quantified in blood drawn before and immediately after surgery and 6, 24, 48 and 72 hours post-operatively. Cognitive testing will also be performed 30 days and 6 months after surgery. Interim analysis after each 20 patients will be performed up to the first 100 patients, with stopping rules if a highly significant difference is observed on the primary outcome variable. Patients randomized but who have no post-operative scan and have no clinical evidence of post-operative stroke will not be included in the sample for the primary analysis. Patients in the observational substudy will undergo the same pre- and post-operative evaluations as patients in the RCT.
Outcome measures - The primary outcome measures are evidence of new ischemic lesions on 48-hour DWI or 30-day DWI or FLAIR, or clinical evidence of new stroke if protocol required scans are not performed, determined at 30 days after surgery. The proportion of patients in each group with primary outcome variable will be tested by a chi-square for proportions. Secondary imaging outcome variables will include the number of new lesions, and the total volume of new ischemic lesions. Secondary outcome measure include all cause mortality, encephalopathy, 30-day and 6-month cognitive decline, evidence of reperfusion injury on 48-hour post-gadolinium FLAIR, new ischemic lesions on 6-month DWI or FLAIR, and changes in values of blood markers. The relationships among new ischemic lesions, cognitive decline, and changes in blood markers will be explored. The association of baseline variables to the prediction of new lesions will be explored using multivariate logistic regression procedures.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Coronary Disease|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Engelman DT, Cohn LH, Rizzo RJ. Incidence and predictors of tias and strokes following coronary artery bypass grafting: report and collective review. Heart Surg Forum. 1999;2(3):242-5.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||November 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
INCLUSION CRITERIA FOR THE OBSERVATIONAL STUDY
EXCLUSION CRITERIA FOR THE OBSERVATIONAL STUDY
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00046410|
|Other Study ID Numbers ICMJE||020314, 02-N-0314|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||November 2007|
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