The largest, multinational cardiac surgery clinical trial, expected to involve 4,700 patients, will be undertaken by researchers at the Population Health Research Institute of Hamilton Health Sciences and McMaster University, located in Hamilton, Ontario.
The CORONARY trial will investigate the differences in outcomes of using on-pump versus off-pump techniques during coronary artery bypass surgery, to document and compare short- and long-tem benefits of both, according to researchers.
Andre Lamy, MD, and Salim Yusuf, MD, and their team of researchers, will span 7.5 years and include 4,700 participants within 100 cardiac surgical centers across 16 countries.
The researchers said that patient recovery benefits of the off-pump technique compared with the on-pump approach are unclear. While it is believed the off-pump technique is a superior method, there is currently not enough evidence to support the theory, the investigators noted.
The study will evaluate the short and long-term safety and efficacy of both techniques, the researchers said. Specific outcomes of interest are neuro-cognitive dysfunction, stroke, cardiovascular mortality, blood transfusions and quality of life.
The study results will determine which technique is best suited to individual patients and help develop best practices in patient care.
“Our goal is always to take cardiac care to the next level through our research,” Lamy said. “This trial will change practice around the world and play a key role in reducing complications for patients who undergo cardiac surgery.”
Study results are expected to be available in 2011.
The Canadian Institutes of Health Research has awarded a $6.5 million grant to fund the trial.