Track topics on Twitter Track topics that are important to you
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:
- Tests of cognitive and neurological function before surgery and 6 months after surgery
- Blood tests to look for cytokines (substances that indicate inflammation) before surgery, immediately after surgery and 1 day after surgery
- MRI scans to detect stroke before surgery, 1 day after surgery and 1 month after surgery.
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.
Washington Hospital Center
District of Columbia
National Institutes of Health Clinical Center (CC)
Published on BioPortfolio: 2014-08-27T03:55:47-0400
It would be useful to study coronary arteriovenous difference of various markers in patients who are undergoing coronary angiography for suspected coronary artery disease. Environmental an...
The overall goal of this study is to determine if non-invasive imaging with state of the art CT coronary angiography can be used to screen for coronary artery disease in high risk patients...
Coronary artery disease is the leading cause of death in USA. Contemporary cardiac care has substantially reduced mortality and morbidity in patients with severe coronary artery disease. H...
The purpose of this study is to determine whether coronary artery CT scanning or nuclear stress testing is better at diagnosing chest pain patients with known coronary artery disease to se...
The purpose of this study is to examine the hypothesis that the presence of complex coronary lesions is associated with endothelial dysfunction, the investigators investigated whether fing...
Cardiovascular disease (CVD) is the major cause of mortality worldwide. Coronary artery disease (CAD) contributes to half of mortalities caused by CVD. The mainstay of management of CAD is medical the...
Long-term patient and kidney survival after coronary artery bypass grafting, percutaneous coronary intervention, or medical therapy for patients with chronic kidney disease: a propensity-matched cohort study.
Revascularization in patients with chronic kidney disease (CKD) and coronary artery disease (CAD) is often deferred because of concern over progression of renal failure.
To assess sex-specific differences regarding use of conventional risks and coronary artery calcification (CAC) to detect coronary artery disease (CAD) using coronary CT angiography (CCTA).
Endothelial dysfunction and coronary artery calcification (CAC) may represent two distinct and separate processes in the development of coronary atherosclerosis. However, the interaction between these...
The analytical paper summarized the results of recent studies of an association of depression, anxiety, and stress with coronary heart disease (CHD). Mental disorders are shown to be associated with i...
Abnormal balloon- or sac-like dilatation in the wall of CORONARY VESSELS. Most coronary aneurysms are due to CORONARY ATHEROSCLEROSIS, and the rest are due to inflammatory diseases, such as KAWASAKI DISEASE.
Surgical therapy of ischemic coronary artery disease achieved by grafting a section of saphenous vein, internal mammary artery, or other substitute between the aorta and the obstructed coronary artery distal to the obstructive lesion.
Malformations of CORONARY VESSELS, either arteries or veins. Included are anomalous origins of coronary arteries; ARTERIOVENOUS FISTULA; CORONARY ANEURYSM; MYOCARDIAL BRIDGING; and others.
Pathological processes of CORONARY ARTERIES that may derive from a congenital abnormality, atherosclerotic, or non-atherosclerotic cause.
An imbalance between myocardial functional requirements and the capacity of the CORONARY VESSELS to supply sufficient blood flow. It is a form of MYOCARDIAL ISCHEMIA (insufficient blood supply to the heart muscle) caused by a decreased capacity of the coronary vessels.
Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza, Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...