FAQs

  • The SmartVascular Dx™ is optimized for patients who are 40 years or older.

  • Anyone over the age of 30 with at least one cardiac risk factor can be tested. Certain clinical situations, including familial hypercholesterolemia (FH) can dictate medical necessity in patients younger than 30 years of age.

    Cardiac Risk Factors

    • Lifestyle Factors such as Smoking, Diabetes, Hypertension or Excessive Stress

    • Family History of Heart Attack, Stroke or Diabetes (Including South Asian, Middle Eastern, or Native American)

    • Current Prescriptions for Cholesterol Medicine, Blood Pressure Medicine, Diabetic Medicine or High-Dose Biotin

    • Autoimmune Diseases such as rheumatoid arthritis, lupus, MS, psoriasis

    • Covid-19 vaccinations or infections

  • The SmartVascular Dx™ Test is a serum blood test that measures nine biomarkers  activated by endothelial injury, and is associated with the leading cause of heart attacks: unstable cardiac lesion  rupture. In this way, it aids in identifying the asymptomatic vulnerable patient.

  • SmartVascular Dx™ identifies risk factors for heart attack and stroke that are not generally measured. This is done by identifying 7 biomarkers that serve as indicators for endothelial Inflammation and soft lesion risk.

    SmartVascular Dx™

    • Quantifies endothelial injury 

    • Identifies residual risk 

    • Predicts acute coronary syndrome (ACS) within 5 years

  • The majority of patients who experience acute coronary syndrome (ACS) have no warning, no symptoms, and in many cases, only one risk factor. No current single biomarker can characterize these lesions, because they involve 10 different pathways.

    With early detection, however, lifestyle modification, medication, dietary supplements, or cardiac procedures can prevent ACS.

    The SmartVascular Dx™ identifies patients with endothelial inflammation who are prone to ACS.

  • The test was developed through a series of longitudinal outcome-based studies with multiple institutions over a 15 year period of collaborative research representing over 40,000 patients. All available markers and global risk factors were tested for their ability to predict ACS in a 5 year period. Three software systems analyzed permutations of all possible groupings of biomarkers and global risk factors. The result was a 13 component algorithm with 7 biomarkers and 4 global risk factors.

    The SmartVascular Dx™ was independently validated at the National Institute of Health (NIH) The National Heart, Lung, and Blood Institute (NHLBI) in the Multi-Ethnic Study of Atherosclerosis (MESA).

  • The SmartVascular Dx™ has a clinical Net Reclassification Index (cNRI) of 43%, and the biomarker assays have a  sensitivity and specificity of 99% and 98%, respectively. The negative predictive value is 97%, and the SmartVascular Dx™ Test identified 61% of patients missed by conventional evaluation

  • The SmartVascular Dx™ should be ordered at least annually. If the test result is borderline, the test can be ordered in 6 months to track progress. If the test result is elevated, it can be repeated every 3-4 months as needed until stable.

  • You can order the test online from Lions Laboratory and schedule blood collection at a location of your choice. You can also ask your doctor about SmartVascular Dx™.