What is the PULS Cardiac TestTM?

The PULS Cardiac Test is a simple, non-invasive blood test that uses 9 protein biomarkers to identify individuals with active, yet undetected subclinical Coronary Heart Disease (the “vulnerable patients”) who are at risk of experiencing an acute coronary event due to endothelial damage leading to unstable lesion rupture, and in whom early intervention can help.

The PULS Cardiac Test empowers physicians to:

Quantify Endothelial Damage: By measuring the body immune response that’s activated by the inflammation or damage to the endothelium/arterial wall.

Predict ACS (Acute Coronary Syndrome): Identifies the asymptomatic “vulnerable” patient who is at risk of ACS (MI, Unstable Angina requiring hospitalization, and Sudden Cardiac Death).

Improve Patient Care: Complements existing diagnostic procedures and enables further evaluation of significantly at risk patients who might have been missed by current methods. Provides guidance for preventive & intervention strategies that improve patient care.

How do Unstable Cardiac Lesions form?

A cardiac lesion begins to form from oxidized or damaged lipids that cause arterial injury. Atherosclerosis is a process of chronic endothelial injury that increases permeability of the arterial wall, allowing oxidized lipid particles to bind and aggregate on the arterial surface - contributing to the formation of lesions (atheroma).

The presence of such compounds stimulates the vessel cells to produce molecules and recruit leukocytes (monocytes, granulocytes, and T-cells) to the arterial walls, and stimulates the proliferation of smooth muscle cells.

The recruited leukocytes are transformed into lipid-laden foam cells and are responsible for the growth of the lesion.4 Growth factors then are released and stimulate the generation of new capillaries through the process of angiogenesis, providing the growing lesion with an adequate blood supply.

Expression of adhesion molecules and chemokines (MCP-1 and others) participate in platelet aggregation, lymphocyte, and monocyte adhesion - further activating the lesion injury.

A physical change in the smooth muscle cells, and the process of cell turnover (apoptosis) produces excessive amounts of collagen, elastin and proteoglycans. This transforms the endothelial injury into a lesion comprised of a thin fibrous cap and lipid core (plaque) that is unstable and prone to rupture.

Why test for Unstable Cardiac Lesions?

Being able to detect the Unstable Lesion that is likely to rupture prior to the cardiac event is crucial in the area of clinical prevention. Given many pathways and processes, each mediated and influenced by the many secreted proteins, it seems likely that the level of such proteins in an individual’s blood sample would serve as biomarkers indicating the level of lesion formation. Yet the protein biomarkers that can be measured with sufficient sensitivity and specificity to indicate Unstable Lesion rupture had, until recently, remained elusive. In the absence of such biomarkers, clinicians had turned to surrogate indicators associated with a higher chance of cardiac events.

How was the PULS Test developed?

The test was developed through 15 years of research period involving collaboration with multiple university centers.

All available biomarkers and clinical risk factors were evaluated statistically to determine which ones were highly indicative of subclinical coronary artery disease and unstable lesion formation and subsequent rupture.

What are the 9 proteins used to detect endothelial injury leading to Unstable Cardiac Lesion rupture?

| The rupture of unstable cardiac lesions is the cause of 75% of all heart attacks. The PULS Cardiac Test uses the following 9 protein biomarkers to measures the body's immune response to coronary artery endothelial damage that leads to unstable lesion rupture:

  1. MCP-3: Guides immune cell direction & activity
  2. sFas: Prevents cell death
  3. Fas Ligand: Initiates cell death and recycling
  4. Eotaxin: Activates immune cells at areas of damage
  5. CTACK: Helps clean up damaged tissue
  6. IL-16: Recruits & activates immune cells
  7. HGF: Stimulates tissue and repair
  8. HDL: Helps remove bad cholesterol
  9. HbA1c: Diabetes marker

How does the PULS Cardiac Test complement and compare to current clinical testing for CHD?

Fifty-percent of Heart Attack victims have normal cholesterol. As such, cholesterol testing alone doesn’t provide a complete picture of cardiac health, and in fact, the role of dietary cholesterol in relation to CHD has been called into question in recent years as the US dietary guidelines are reevaluated.

Many other methods, such as the CAC test and more invasive methods of vascular imaging require strong presentation of symptoms before a physician will recommend them.

The PULS Test bridges this gap by providing unprecedented diagnostic information that includes and expands upon lipid profiling without the invasiveness of other methods. The PULS Test aims to identify vulnerable, asymptomatic patients with active, yet undetected CHD, and for whom early intervention can help.

How is the PULS Test different from other CHD assessments?

The PULS Cardiac Test identifies patients that may not be identified as high-risk using other tests, as well as patients who are at low risk for heart attack, ensuring that interventions are focused only on those patients who actually need them. Unlike traditional tests for Heart Disease, the PULS Test can detect the early stages of endothelial or arterial injury, diagnose disease stage, and predict how likely the disease will cause an unstable cardiac lesion rupture (myocardial infarction). The PULS Test is:

  • Validated in a multi-ethnic population
  • Outcome data demonstrates clinical utility in identifying patients in danger of developing disease
  • Conforms to current ACC/AHA (ATP IV) guidelines
  • Motivates patients to adhere to physician recommendations

Is the PULS Test right for my patients?

The PULS Test is for patients 40 years or older who have had no previous history of a Heart Attack (myocardial infarction).

Is there a Heart Disease test for patients under 40?

AHA Guidelines recommend getting a baseline CHD assessment in individuals starting at age 20. Basic and Expanded Lipid Profiles are baseline assessments are available for patients under 40 years old. Contact Client Services at (866) 299-8998 for more information.

How is the PULS Cardiac Test performed and what are the specimen requirements?

PULS test is a simple, non-invasive, blood test that requires 1 SST and 1 Lavender tube of blood. Based on your location, we provide a number of convenient ways to perform blood draws. Contact our Client Services team at (866) 299-8998 for more information.

What will be included in the PULS Test results?

The test results will include:

  • Your patient’s complete Cardiac Profile with individual measurements for each of the 9 protein biomarkers that contribute to their cumulative 5-year unstable cardiac lesion diagnosis and likelihood of rupture. This score will then be categorized into a low, borderline, or elevated category.
  • Your patient’s “Heart Age” which shows your Cardiac Score relative to your Age and Gender group.
  • Recommended lifestyle modifications that may help maintain or reduce your chances of a Heart Attack.

PULS Test results will allow you to then determine the most appropriate course of action for the patient based on the latest clinical guidelines.

How do I order the PULS Test for my patients?

Contact our Client Services team at (866) 299-8998 to set-up your new account for convenient ordering and to request ship kits.

How do I interpret PULS Cardiac Test Results?

PULS Cardiac Test results provide a personalized 5-year Cardiac Profile score that conforms to ACC/AHA Guidelines for Normal, Borderline, or Elevated Risk:

Normal (<3.5%): These patients are in the desired range. Reviewing good nutrition and exercise habits and identifying any areas of concern like heart age, rising BMI or family history will dictate if additional recommendations are encouraged.

Borderline (3.5-7.49%): Patients in the intermediate range are generally early in disease progression. Often times, simple lifestyle modifications such as a healthy diet, physical activity, smoking cessation, and stress management can bring these individuals back into the normal range.

Elevated (>7.5%): These patients have an elevated risk of an ACS and should be treated as such using the ACC/AHA guidelines. Further evaluation is recommended to better define the clinical picture and treatment plan. If the patient is not currently under the care of a cardiologist, referral to a cardiologist is recommended. Case studies have shown that some patients with high-risk results who have not acted on the information have experienced heart attacks within weeks or months of the test.

How has the PULS Cardiac Test demonstrated clinical utility and improved patient care?

| In a large clinical trial, the PULS Cardiac Test identified 61% of patients who went on to have a cardiac event, and who would have been missed by established risk factors. Click here for more information.

In a clinical survey, 70% of physicians changed their treatment plan based on PULS Cardiac Test results. The study included physicians in the areas of cardiology, internal medicine, family practice, and obstetrics/gynecology.Click here for more information.

What do I do when my patient has normal lipid levels and a healthy lifestyle, but has an elevated PULS Cardiac Profile Score?

These individuals are still at risk. In fact, they are the ones who are missed most often and go on to have a heart attack.

These patients should be further evaluated to assess disease progression. Almost all individuals have some modifiable lifestyle factors that can be improved. Exercise and diet are frequently recommended as one of the most important ways to improve risk.

As recommended in the ACC/AHA Cardiac guidelines, if an individual follows recommended guidelines for a healthy lifestyle but is still at high-risk, medication should be considered.