Capital Health Enrolls First Patient in Research Study of Investigational Drug for Use in Patients with Aneurysmal Subarachnoid Hemorrhage
Only Hospital in NJ Approved for Study
Trenton, NJ (January 18, 2010) – Capital Health's Stroke and Cerebrovascular Center of New Jersey has enrolled its first patient in CONCIOUS-3, a study to assess the investigational drug clazosentan in patients with aneurysmal subarachnoid hemorrhage (aSAH). The Stroke and Cerebrovascular Center of New Jersey is the only hospital in New Jersey approved for participation in the international study and is one of only a few participating in the tri-state region.
CONCIOUS-3 is a study to assess the safety and efficacy of clazosentan in reducing vasospasm-related morbidity and all-cause morbidity in adult patients with aSAH treated by endovascular coiling. Vasospasm is a post-rupture complication that occurs when other blood vessels in the brain contract and limit blood flow to portions of the brain. This in turn can lead to stroke or tissue damage. Vasospasm is the leading cause of disability or death following a burst aneurysm.
"This study is important because it is another opportunity to look for ways to potentially prevent complications for our patients that can be debilitating, or fatal," said Dr. Erol Veznedaroglu, director of Neurosciences and Endovascular & Cerebrovascular Neurosurgery at Capital Health who is serving as a primary investigator on the study.
The primary objective of the study is to demonstrate that at least one dose of clazosentan reduces the incidence of vasospasm-related morbidity and all-cause morbidity within 6 weeks post aSAH in patients who have been treated by endovascular coiling.
In addition to Dr. Veznedaroglu, as a primary investigator -- Dr. Kenneth Liebman, director, Neurosurgical Critical Care and Dr. Rashid Janjua are sub-investigators on the study. Coordinators for the study's implementation at Capital Health are Kristen Smith, clinical research coordinator for Neurosciences and Sarah Dombroski, RN, clinical research nurse for Neurosciences.
Aneurysms are weak or thin spots in blood vessels that have blistered out from the vessel and filled with blood. When the pressure becomes too great, an aneurysm can rupture or leak blood into brain tissue. When that blood fills the subarachnoid space surrounding the brain a patient suffers from subarachnoid hemorrhage.
During endovascular treatment using coils for an aneurysm, a catheter is guided through the groin area into the femoral artery where it is then threaded up through the vascular system to the location of the aneurysm. During the procedure, the vascular system is seen using fluoroscopic imaging, which maps out the arteries through which the catheter and coils will travel to the site of the aneurysm. Small platinum coils are then inserted into the aneurysm, blocking the flow of blood into the bulge in the blood vessel.
CONCIOUS-3 is designed to study clazosentan's use within a certain time frame for patients who have been treated using endovascular coiling. Additional criteria must be met for patient inclusion in the study. In addition, there are criteria that could exclude a candidate from inclusion in the study despite being treated using coils.
Capital Health Regional Medical Center is a state designated Comprehensive Stroke Center, which establishes the hospital as a leader in providing advanced care for patients suffering from stroke. Capital Health has also received certification from The Joint Commission -- the gold standard for stroke care. Early last year, Capital Health announced the opening of the Stroke and Cerebrovascular Center of New Jersey at Capital Health, which gave the hospital an even greater ability to treat the most critical cerebrovascular patients utilizing the most advanced technologies and treatments. More than 20 team members joined the Stroke and Cerebrovascular Center from Jefferson Hospital for Neuroscience including Dr. Erol Veznedaroglu and Dr. Kenneth Liebman as part of an experienced team committed to the care of the most complex stroke and cerebrovascular cases.
About Capital Health
Capital Health is a regional leader in advanced medicine, with significant investments in advanced technologies and experienced physicians. Comprised of its Mercer Campus and Capital Health Regional Medical Center in Trenton, N.J. and the Capital Health in Hamilton outpatient facility, Capital Health has twice received Magnet recognition for nursing excellence. Capital Health is a growing healthcare organization with construction underway for a new, state-of-the-art hospital in Hopewell Township, N.J. and significant expansion of services at Capital Health Regional Medical Center in Trenton, both scheduled to be completed by 2011.
Capital Health's commitment to making the latest technology available to patients in this region is headlined by the area's only CyberKnife® Robotic Surgery System and the first da Vinci® Surgical System in Mercer County which are used respectively for non-invasive and minimally invasive surgical treatments. As a state designated Comprehensive Stroke Center, Capital Health is also home to the Stroke and Cerebrovascular Center of New Jersey featuring two of the country's most experienced neurosurgeons. Capital Health has the region's only trauma center and state designated regional perinatal center, and operates the mobile intensive care unit and psychiatric emergency screening center serving all of Mercer County.