NEWLY APPROVED TEST IDENTIFIES PATIENTS AT RISK FOR IMPENDING “MAJOR ADVERSE CARDIAC EVENTS”Jun 28, 2005 | www.Newsinferno.com
On May 10, the FDA approved an application by Prognostix, Inc. of Cleveland, Ohio, to market (to doctors) a test kit known as the CardioMPO which, in clinical trials, proved quite accurate in predicting which patients were at risk to suffer a “major adverse cardiac event.”
The application submitted by Prognostix on January 6 of this year defines the test as an “enzyme immunoassay” intended for the “quantitative determination of myeloperoxidase (MPO) in human plasma, to be used in conjunction with clinical history, ECG and cardiac biomarkers to evaluate patients presenting with chest pain that are at risk for major adverse cardiac events, including myocardial infarction, need for revascularization, or death.”
Patients complaining of chest pain or discomfort have always presented a difficult diagnostic challenge whether in an emergency room, doctor’s office, or non-medical setting. Doctors are constantly being called upon to determine if a patient is suffering some relatively minor transitory condition or a more serious cardiac event requiring immediate aggressive intervention.
The most common symptom of a heart attack is chest pain or chest discomfort, but in many cases even the patient is uncertain if they are having a heart attack. However, many cases go undiagnosed even in the emergency department, and this diagnostic error makes acute myocardial infarction (AMI) the single leading malpractice litigation-related condition.
In addition, because the most common profile for AMI is in older men (usually over 45), AMI is often misdiagnosed in women or younger adults. In any patient, however, AMI can have a variety of presentations, and diagnostic tests such as an EKG may still be normal. Misdiagnoses of AMI include gastrointestinal disorders (26% of misdiagnoses), musculoskeletal pain (21%), or respiratory ailments such as pneumonia or bronchitis (6%).
Moreover, there are also less serious disorders that are mistakenly believed to be heart attack. A common example are people having a panic (anxiety) attack and will rush to an emergency room believing they are dying from a heart attack.
The CardioMPO test provides an additional means of quickly separating minor medical emergencies from life threatening ones. When used in combination with other diagnostic tools and taken into consideration with other risk factors, the test may prove to be a life saver.
MPO is a protein produced in white blood cells. It is also found in clogged areas of heart arteries which are vulnerable to rupture. Elevated levels of MPO in people with chest pain or discomfort signals the existence of short-term risk of a major adverse cardiac event such as a heart attack or the need for surgical intervention to restore normal blood flow to the heart. High MPO levels are also a possible indicator of an increased risk of heart-related death within 6 months.