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PreVu Introduction


The PreVu® Non-Invasive Skin Cholesterol
Point of Care (POC) Test

The PreVu® Non-Invasive Skin Cholesterol Point of Care (POC) Test is a Canadian developed, non-invasive risk assessment technology designed to measure epidermal cholesterol - a valuable new biomarker that represents an advance in risk assessment for coronary artery disease (CAD).

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Designed for delivery through community healthcare settings including pharmacies as a general risk assessment screen for CAD, or for application through clinical channels as well, the PreVu POC Test is:

Skin cholesterol is the cholesterol that has been deposited and diffused into tissue, as opposed to freely circulating in the bloodstream, and elevated skin cholesterol has been shown in clinical trials to be strongly associated with significant CAD as measured by treadmill stress testing, coronary angiography, coronary calcium, carotid artery thickening, and carotid artery plaque.

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Elevated Skin Cholesterol and Risk of Coronary Artery Disease

Individuals with elevated Skin Cholesterol levels have been shown to have a much greater risk of scoring an abnormal result in these five widely recognized and utilized cardiovascular tests (see the table below).

Risk of Abnormal clinical Cardiovascular Test with Elevated Skin Cholesterol Test Measures If Test Result Abnormal
2.6 times greater risk
of abnormal Treadmill Stress Test
Functional cardiovascular disease Possible coronary artery disease
1.4 times greater risk
of abnormal Coronary Angiography
Coronary artery atherosclerosis Blockage of coronary arteries
3.0 times greater risk
of abnormal Coronary Calcium
Calcified coronary plaque Higher risk of future cardiac events
2.0 times greater risk
of abnormal Carotid Ultrasound (IMT)
Carotid artery atherosclerosis Increased risk of heart attack and stroke
3.0 times greater risk
of abnormal Carotid Ultrasound (Plaque)
Carotid artery atherosclerosis Increased risk of heart attack and stroke

The PreVu POC Test is not a replacement for serum cholesterol testing though, as the two measurements do not correlate and are measuring cholesterol in different forms. The skin contains approximately 11% of all the cholesterol found in the human body.1 Cholesterol diffused and deposited in the skin is of a different molecular composition, while in the blood it is fractionated and protein bound.

The PreVu POC Test generates a color change on the palm through the application of reagents, and the hue is then measured bearing relation to the amount of cholesterol deposited in the epidermis. The quantitative number generated is reflective of the patient's risk of CAD.

Any patient can be evaluated against the continuum of data to see their relative risk against a larger population. However, a skin cholesterol value of 110 is chosen (based on the clinical studies) as the value at which patients begin to acquire an increased burden of risk.2 As skin cholesterol values increase, each 10-unit increase has been shown to augment the burden by an additional 7%.3

PreVu does not diagnose the presence or absence of angiographic CAD, but helps to identify patients who may be at higher risk for CAD.

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Additional Clinical Data Representations

The following charts additionally demonstrate the strong link between elevated levels of skin cholesterol and risk of actual anatomical disease, based upon clinical data.


Odds Ratio Increase in Carotid Plaque Presence and CIMT

Key Findings: Elevated skin cholesterol was associated with an increase in the odds of having CIMT and carotid plaque - potent predictors of myocardial infarction and stroke. The relationships among elevated skin cholesterol, increased CIMT and carotid plaque presence were seen in low, intermediate and high risk subjects and were independent of cardiovascular risk factors.

Graph

Adapted from Stein JH, Tzou WS, DeCara JM, et al. Usefulness of increased skin cholesterol to identify individuals at increased cardiovascular risk (from the Predictor of Advanced Subclinical Atherosclerosis Study). Am J Cardiol 2008;101:986-991

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Odds Ratio Increase of Any Disease / Multivessel Disease

Key Findings: Skin cholesterol showed significant and positive correlations with systolic blood pressure, LDL-C and the Framingham CAD risk calculation model. Skin cholesterol also correlated significantly with inflammatory markers, particularly ICAM-1.

Graph

Adapted from Sprecher DL and Pearce GL. Skin cholesterol adds to Framingham risk assessment. Am Heart J 2006;152:694-6

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Increase in Skin Cholesterol by Rate of Prior MI and / or CABG

Key Findings: Patients with a history of MI and/or CABG had significantly higher skin cholesterol than those without, this remained after adjustment for traditional risk and extent of angiographic disease.

Graph

Adapted from Sprecher DL and Pearce GL. Elevated skin tissue cholesterol levels and myocardial infarction. Atherosclerosis 2005;181:371-373

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Odds Ratio Increase in Presence of Coronary Calcium vs. Lipid Predictors

Key Findings: Skin cholesterol levels were significantly associated with coronary calcium (a measurement of coronary artery disease) in Caucasians. Though skin cholesterol was not associated with coronary calcium in African-Americans, neither were traditional blood cholesterol levels.

Graph

Adapted from Vaidya D, Ding J, Hill JG, et al. Skin tissue cholesterol assay correlates with presence of coronary calcium. Atherosclerosis 2005;181:167-73

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Correlation with Angiographic Disease

Key Findings: Skin cholesterol levels were significantly higher in subjects with increased narrowing of their coronary arteries and this relationship remained after adjusting for traditional risk factors

Graph

Adapted from Sprecher DL, Goodman SG, Kannampuzha P, et al. Skin tissue cholesterol (Skin Tc) is related to angiographically-defined cardiovascular disease. Atherosclerosis 2003;171:255-258

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Correlation with Positive Stress Tests

Key Findings: Skin cholesterol was found to be correlated with abnormal stress test outcomes and this relationship did not diminish after adjustment for blood lipids and other risk factors.

Graph

Adapted from Zawydiwski R, Sprecher DL, Evelegh MJ, et al. A novel test for the measurement of skin cholesterol. Clinical Chemistry 2001;47:1302-4

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Distribution of Skin Cholesterol in Case and Control Subjects


Graph

Data on File, Miraculins Inc.

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Helping Healthcare Professionals Assess Patient Risk of Coronary Artery Disease

The PreVu POC Test is a new risk assessment technology that can assist healthcare professionals in the earlier detection and primary prevention of CAD. It has been designed to serve as a general population screen helping to identify individuals with hidden, high levels of risk and to be the first step in a global risk evaluation process.

The PreVu POC Test is ideal for rapid, non-invasive general screening and has been specifically designed for delivery in a community healthcare setting such as the neighborhood pharmacy or in cardiovascular screening clinics. It can be completed within a few short minutes, is completely non-invasive and painless, and provides instant results for on-the-spot discussion and next-step consultation.

Outside of a medical office environment where physician consultation and other CAD testing (including invasive testing such as serum draw) may not be available, the PreVu POC Test is intended to act as both a launch point and a tipping point, impressing upon individuals the critical importance of building upon this skin cholesterol risk assessment start and to see their healthcare professionals for a full and complete evaluation of all their global risk factors for CAD.

Within a clinical environment, the PreVu POC Test can also be utilized at the healthcare professional's discretion as a general screen and risk assessment tool as a prelude to a global risk evaluation of a patient or as part of the process itself.

PreVu has proven in focus testing to excite the public's interest and draw people into the national cholesterol conversation anew. Regardless of where a patient may encounter the PreVu POC Test - out in the community or in their doctor's office - the end goal is the same; to generate increased opportunities for healthcare professionals to conduct global CAD risk assessments on those in need, to help guard against that critical first coronary event.

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Coronary Artery Disease - Canada's Leading Killer

The World Health Organization2 states that cardiovascular diseases (CVDs) are now the leading cause of death and disability in the world:

In Canada, the statistics4 are just as striking in their relative scope and scale:

Many of these first events, if not fatal, are disabling and/or require lengthy and costly medical care. At the same time, the evidence that most cardiovascular disease is actually preventable continues to strengthen.

Most patients who develop coronary artery disease (CAD) have at least one major CAD risk factor5 such as:

Consequently, identifying these patients with subclinical cardiovascular disease who could benefit from more intensive primary prevention measures to prevent a first event is crucial. Guidelines recommend that risk factor assessment in adults should begin as early as age 20 and that all adults who are 40 or over should know their absolute risk of developing CAD.6

The PreVu® Non-Invasive Skin Cholesterol Point of Care (POC) Test can help healthcare professionals in the risk assessment of patients for CAD. And if patients at higher risk for developing CAD can be identified earlier in the course of their illness, it is not unreasonable to expect improved outcomes towards guarding against a first heart attack event.

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References

  1. Sabine, JR (1977) Cholesterol, New York: Marcel Dekkar
  2. World Health Organization Atlas on Cardiovascular Disease Prevention and Control, 2011
  3. Sprecher DL, Goodman SG, Kannampuzha P, et al. Skin tissue cholesterol (Skin Tc) is related to angiographically-defined cardiovascular disease. Atherosclerosis 2003;171:255-58
  4. Heart and Stroke Foundation of Canada
  5. Greenland P, Smith SC, Grundy SM. Improving coronary heart disease risk assessment in asymptomatic people: Role of traditional risk factors and non-invasive cardiovascular tests. Circulation 2001;104:1863-67.
  6. Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) Executive Summary; NHLBI 2001.