Comparison of the Risk of Stroke With On- Versus Off-Pump Coronary Artery Bypass Grafting

NCT00046410 | Completed

• 2 other identifiers: 02031402-N-0314
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Disease

Keywords

MRI; Diffusion; Cognitive; Stroke; Heart; Coronary Artery Disease; Heart Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or greater
• Neurologically and cognitively independent prior to surgery (mRS less than 2)
• Patients with stable or unstable angina pectoris (Braunwald Class I-II, B) and/or documented ischemia due to single or multivessel disease and a normal, mild or moderately impaired global left ventricular function
• Patients who are a candidate for CABG
• Patients who are eligible for on-pump and off-pump CABG: Patients with single or multi-vessel disease in which one or more significant stenosis(es) in at least one major epicardial coronary artery (left anterior descending artery, left circumflex artery, right coronary artery, or the combination of one of the former and a side branch providing different myocardial territories).

You may not qualify if:

• History of CABG
• Need for concomitant major surgery (e.g., valve replacement, resection ventricular aneurysm, congenital heart disease, vascular surgery of the carotid artery or thoracic-abdominal aorta) or salvage or emergency CABG
• Concomitant medical disorders making clinical follow-up of at least 6 months unlikely or impossible (e.g., neoplastic disease, hepatic failure)
• Q-wave myocardial infarction in the previous 6 weeks
• Overt congestive heart failure
• Hemorrhagic diathesis or hypercoagulability
• Any contraindication for off-pump CABG (i.e., thoracic deformities)
• Patients whose procedure requires no clamps (i.e., LIMA to LAD)
• Patients with hemodynamic instability, severe left ventricular dysfunction (ejection fraction less than 25%), significant cardiac enlargement, frequent arrhythmia or respiratory instability
• Carotid stenosis (greater than or equal to 60%) by magnetic resonance angiography or carotid Doppler
• Patients with a history of dementia, cognitive dysfunction (MMSE score less than 24) or psychiatric disorder
• Any MRI contraindication (cardiac pacemaker or defibrillator, insulin pump, aneurysmal clip, implanted neural stimulator, cochlear implant, metal shrapnel or bullet, etc)
• Unable to give informed consent
• Patients with the following intraoperative findings such as 1) hemodynamic instability with positioning, 2) inadequate visualization, 3) inappropriate vessels (i.e., small, intramyocardial), or 4) heavily calcified aorta by palpation
• Age 65 years or greater

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

• 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.

  PMID: 11276484 BACKGROUND

MeSH Terms

Conditions

Coronary Disease; Stroke; Coronary Artery Disease; Heart Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 27, 2002
• First Posted: September 30, 2002
• Study Start: September 25, 2002
• Study Completion: November 15, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-11-15

Locations

US (1)