Vanderbilt Heart Participates in Study of New Rapid Cooling Technology that May Reduce Effects of Heart Attacks

Newswise — Vanderbilt Heart and Vascular Institute is participating in the VELOCITY study, a randomized controlled clinical study to assess the safety and feasibility of a rapid cooling system for heart attack patients that could minimize damage to the heart. Vanderbilt is one of six sites in the United States and Canada, and is the only one in Tennessee, to offer this study of the Velomedix™ rapid therapeutic hypothermia system in patients with acute myocardial infarctions (AMIs, also known as heart attacks). Vanderbilt Heart has already enrolled two patients in this investigational study which will include up to 60 patients with a severe form of AMI, called ST-segment elevation myocardial infarction (STEMI). Participants in the study are randomized to one of two arms. Patients in the control arm receive the current standard treatment for STEMI, namely percutaneous coronary intervention (PCI) without therapeutic hypothermia. During this treatment, the physician reopens the blocked blood vessel and returns blood flow to the affected region. Patients in the treatment arm are rapidly cooled first to a temperature of less than 35°C (95°F) just before receiving the same PCI treatment. The Velomedix™ system circulates cold fluid throughout the patient’s body to achieve the lower temperature. “The principle behind cooling is to prevent injury to the heart muscle that can occur when we restore normal blood flow to the heart after a heart attack,” said John McPherson, M.D., associate professor of Medicine and the Vanderbilt principal investigator for the VELOCITY study. Peter Fong, M.D., an interventional cardiologist who treated the first patient to receive cooling at Vanderbilt Heart, commented, “The procedure was successful thanks to the great teamwork by our cardiac cath lab staff. The patient did well and we hope therapeutic hypothermia proves to be successful in substantially reducing the amount of the heart damaged by an attack.” According to the American Heart Association, AMI affects 935,000 people in the U.S. yearly, reducing the heart’s ability to pump the needed amount of blood throughout the body. STEMI can lead to congestive heart failure, a substantially debilitating disease and one of the most costly conditions for our health care system. To be considered for the study, potential candidates must meet the following criteria:· Must be 18 to 85 years of age· Having an ST-segment elevation myocardial infarction (≥ 2mm)· Arrive at Vanderbilt within six hours of the start of symptoms· Have no previous myocardial infarction· Currently not be on dialysis treatment· Able to undergo MRI scans· Must be willing to return for a follow-up exam including a second MRI scan approximately 30 days after initial treatment “In three previous studies, we have seen that if a patient is cooled to below 35°C prior to reopening the blocked coronary artery, the size of the heart attack may be reduced substantially,” said Gregg Stone, M.D., of Columbia University Medical Center / New York-Presbyterian Hospital and co-principal investigator of the VELOCITY study. “The cooling approach in this study may prove to be effective in cooling patients fast enough to provide benefit without significantly delaying reperfusion.” Additional information about the VELOCITY study is also available on www.clinicaltrials.gov.