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New Test To Detect Heart Disease Risk
 

Heart disease causes 1 in 4 female die in the United States, and coronary heart disease (CHD) is the most common form of the condition. CHD is a term for the buildup of plaque in the heart’s arteries that could lead to heart attack. Risk factors for CHD include high blood pressure, smoking, high cholesterol and high blood glucose.

Every year, about 375,000 Americans are killed by CHD. Women over the age of 55 and men over the age of 45 are most at risk of CHD. Around 64 percent of women who die from CHD have no previous symptoms of the condition, according to the Centers for Disease Control and Prevention (CDC).

On December 15, 2014, the Food and Drug Administration (FDA) have approved a new test that might help health care professionals identify these patients before they experience a serious CHD event, like a heart attack. The test is designed for both men and women with no history of heart disease, but studies have shown that the test is more accurate in predicting CHD risk in women, especially African-American women. Cardiovascular disease kills nearly 50,000 African-American women annually. 49 percent of African-American women age 20 and above have heart disease.

The test, known as called the PLAC Test for Lp-PLA2 (lipoprotein-associated phospholipase A2). It measures the activity of Lp-PLA2, which is an enzyme that is an indicator of vascular inflammation, in a patient's blood sample. Vascular inflammation is a sign of plaque accumulation in the arteries, and this build-up of plaque can clog the arteries and cause CHD. The test can indicate whether artery-narrowing plaque is building up and irritating the lining of the blood vessels.

Patients will have high risk of a CHD event like a heart attack or stroke if their Lp-PLA2 activity over 225 nanomoles per minute per milliliter (nmol/min/mL) in their blood. Patients with Lp-PLA2 activity below 225 nmol/min/mL are classed as lower risk for a CHD event.

Before approving the PLAC Test for Lp-PLA2, FDA conducted a review of all available studies on the technique. Their review included the PLAC Test for Lp-PLA2 Activity Validation Study, in which the test was administered on 4,598 participants aged between 45 and 92 years who had no history of CHD. 58.3 percent of these participants were women and 41.5 percent were black.

All participants were followed for an average of 5.3 years and occurrence of CHD events were recorded among each individual. It was found that 7 percent of the participants with Lp-PLA2 activity higher than 225 nmol/min/mL experienced a CHD event, compared with only 3.3 percent of participants with Lp-PLA2 activity lower than 225 nmol/min/mL.

When the researchers analyzed the data by subgroups, they discovered that the rate of CHD events was much higher among black women whose Lp-PLA2 activity levels were higher than 225 nmol/min/mL, compared with other subgroups with similar Lp-PLA2 activity. CHD events were also found to be more common among women with Lp-PLA2 activity levels over 225 nmol/min/mL than men with such levels. As a result, FDA labeled the test with different performance information for black women, white women, black men and white men.

Currently, doctors need to run lots of different tests to assess someone's risk of heart disease. They measure cholesterol, blood pressure and heart rate. They test the electrical signals that keep the heart beating and they might also run imaging tests to check for clogged arteries. Cholesterol tests that examine for low-density lipoprotein (LDL or bad cholesterol) do not do a very good job of predicting who will have a stroke. Half of cardiovascular events like stroke are in people with healthy LDL levels.

It is hoped that the clearance of the new test will improve preventive care and lower CHD related mortality and morbidity.

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