Headlines
As reported by the New Britain Herald, January 15, 2011.
Ground-breaking Trial at UConn Health Center
By Scott Whipple
The Pat and Jim Calhoun Calhoun Cardiology Center of the UConn Health Center enrolled its first cardiac imaging study patient on Friday.
The center has become a test site for a groundbreaking clinical trial. Purpose of the trial is to determine which test is most accurate when detecting a coronary blockage.
The National Institutes of Health obtained a federal grant in October 2009 to study the use of cardiac imaging to diagnose problems associated with chest pain, the most common clinical cardiology problem.
According to Dr. Erick Avelar, director of noninvasive cardiac imaging at the Calhoun Cardiology Center, the Prospective Multi-center Imaging Study for the Evaluation of Chest Pain, or PROMISE study, is the first randomized imaging trial in the history of cardiology. "'Randomized' means that for those enrolled in the study the determination about whether they undergo either a functional test or a cardiac CT imaging test will be determined by chance," Avelar said. "This is similar to a coin flip. In this study, the chance of being assigned to either group is 50-50."
Avelar graduated from medical school in Brazil with advanced studies at Harvard Medical School and Mass General Hospital. He joined the UConn Health Center faculty in 2008.
"Coronary CT is costly, exposes patients to radiation, and is not the current standard of care," Avelar explained. "For these reasons, these studies are generally not covered by insurance. For this study, which assesses the value of this information in relation to the risks and costs, the NIH is covering the cost of the cardiac CT testing."
The targeted study population is chest pain patients with low to intermediate probability of significant obstructive coronary artery disease, including men 55 and older and women 65 and older. Men as young as 45 and women as young as 50 may also be eligible depending on their individual risk factors.
Avelar says a major concern when a patient has chest pains is a possible blockage in the coronary arteries.
Risk factors include hypertension, history of a stroke, smoking and diabetes.
The study will eventually enroll 10,000 patients at more than 200 sites in the U.S. The UConn Health Center was the first site in Connecticut to join this study, serving as principal investigator.
Patients in the study will be allowed to continue taking their blood pressure and cholesterol medications.
However, anyone suffering from kidney disease or has had a heart attack or bypass surgery will not be eligible for the study.
The last subject enrolled will be in June 2012; the "data lock" — when data will no longer be collected — is October 2014.
And the hoped-for outcome?
"That for the first time in cardiology we will be able to determine the accuracy and specificity of tests that can detect coronary blockages," Avelar said.
"We will know which test can tell you for sure that you have coronary disease and with decreased costs and a decreased risk of invasive procedures."
For further information about the PROMISE study telephone (860) 679-3666. More information about the Pat and Jim Calhoun Cardiology Center is available at http://heart.uchc.edu.