New Test Helps Increase Quality of Cardiac Care and Accuracy of Diagnosis
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New Test Helps Increase Quality of Cardiac Care and Accuracy of Diagnosis

INDIANAPOLIS, April 15, 1996 -- Each year, six million people in the U.S. visit emergency departments for chest pain. Four million are admitted. Over 700,000 are placed in the critical care units unnecessarily at an estimated cost of $15,900 for a two-day stay to "rule-out" an acute myocardial infarction (AMI), otherwise known as a heart attack. Approximately 68 percent were not experiencing a heart attack and could have received more cost effective care. Of those who experience a heart attack, over 500,000 will die.

But even more startling, is in addition to spending millions to "rule-out" heart attacks, about 34,000 patients each year are released from hospitals with undiagnosed, and often deadly, heart attacks. In fact, missed heart attacks account for one out of every five malpractice awards.

These alarming statistics confirm the need for a new diagnostic tool that will help physicians diagnose and triage chest pain patients quickly and accurately. The ability to rapidly identify heart muscle damage allows the immediate initiation of appropriate therapy as well as defines high risk patients. This results in patients experiencing an increased quality of care, decreases in unnecessary medical expense and very importantly, it would help reduce the number of misdiagnoses.

At the American College of Cardiology Annual Scientific Convention in Orlando, FL, a new product recently cleared by the U.S. Food and Drug Administration for rapid and accurate diagnosis of heart muscle damage, was on display.

The CARDIAC T(R) Rapid Assay from Boehringer Mannheim Corporation is a hand-held disposable instrument, which looks strikingly like a typical easy-to-use home pregnancy test. It can be used bedside in the emergency department or critical care unit to identify myocardial (heart) damage in patients presenting with chest pain or other cardiac- related symptoms. Within minutes, this test can definitively detect the presence of a cardiac-specific protein, troponin T, that is only found in those patients who have experienced heart muscle damage.

In the January issue of "Clinical Lab News," Dr. Elliott Antman, MD, director of the coronary care unit at Brigham and Women's Hospital in Boston stated, that reviewing patient histories and electrocardiograms (ECG) are current methods used by physicians to evaluate chest pain patients. But he said that you know instantly that the patient had a heart attack in only about 40 to 50 percent of cases.

"The bottom line is that this test is a major improvement in the care of patients with chest pain," said Magnus Ohman, MD, assistant professor of cardiology at the Duke University Medical Center in Durham, N.C., in the same interview with "Clinical Lab News," a leading medical trade publication.

The CARDIAC T Rapid Assay can be used along with clinical history and ECG to identify heart muscle damage. But unlike other tests, it is the only one sensitive enough to detect the minor damage clinically proven to be predictive of major cardiac events. This ability to distinguish between patients at risk allows physicians to provide the most effective, cost efficient care.

Cardiac troponin T is a cardiac-specific contractile protein that is only released and detectable in blood when heart damage has occurred. Used along with clinical history and ECG, it is the only test that has been cleared by the FDA for detection of the full range of heart damage from minor to acute. In the "Global Use of Strategies to Open Coronary Arteries" (GUSTO IIA) substudy, baseline troponin T measurement was the single most important predictor of 30-day mortality in patients with acute ischemic syndromes.

The cardiac-specific troponin T stays in the blood stream longer after damage and as a result, offers physicians an extended diagnostic window. Some patients do not immediately go to the emergency department for treatment, so the ability to detect damage for up to two weeks, allows for an accurate diagnosis despite the time lapse between presentation of symptoms and testing. troponin T can be detected as early as one to three hours after heart muscle damage has occurred, and may remain elevated up to two weeks afterwards. Other cardiac proteins, return to normal within one to three days.

More than 130 clinical articles have been published on cardiac troponin T and theCARDIAC T assays, supporting their effectiveness in the detection of heart damage. For more information, please call 800-428-2336 or write Boehringer Mannheim Corporation, 9115 Hague Road, P.O. Box 50457, Indianapolis, IN 46250-0457.

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