Test Catalog

Test Id : CERAM

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MI-Heart Ceramides, Plasma

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Evaluating the risk of major adverse cardiovascular events within the next 1 to 5 years

Highlights

Plasma ceramides predict risk of myocardial infarction, coronary revascularization, acute coronary syndrome hospitalization and mortality within 5 years.

 

Risk conferred by plasma ceramides is independent of low-density lipoprotein (LDL) cholesterol, C-reactive protein, LDL particles, and lipoprotein-associated phospholipase A2.

 

Plasma ceramides can be lowered by diet, exercise, simvastatin, rosuvastatin, and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors.

Method Name
A short description of the method used to perform the test

Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

MI-Heart Ceramides, P

Aliases
Lists additional common names for a test, as an aid in searching

N-palmitoyl-sphingosine

N-stearoyl-sphingosine

N-nervonoyl-sphingosine

N-lignoceroyl-sphingosine

Cer(d18:1/16:0)

Cer(d18:1/18:0)

Cer(d18:1/24:0)

Cer(d18:1/24:1)

Cer16:0

Cer18:0

Cer24:0

Cer24:1

Ceramide

Ceramides

CERAM

Specimen Type
Describes the specimen type validated for testing

Plasma EDTA

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Patient Preparation: Patients should not be receiving Intralipid because it may cause false elevations in measured ceramides.

Collection Container/Tube: Lavender top (EDTA)

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge, aliquot at least 1 mL of plasma into a plastic vial and freeze within 8 hours.

Forms

If not ordering electronically, complete, print, and send a Cardiovascular Test Request Form (T724) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Plasma EDTA Frozen (preferred) 30 days
Refrigerated 24 hours
Ambient 8 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

Evaluating the risk of major adverse cardiovascular events within the next 1 to 5 years

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

MI-Heart Ceramides is a blood test that measures risk for adverse cardiovascular events and quantifies plasma ceramides. Plasma ceramides are predictors of adverse cardiovascular events resulting from unstable atherosclerotic plaque. Ceramides are complex lipids that play a central role in cell membrane integrity, cellular stress response, inflammatory signaling, and apoptosis. Synthesis of ceramides from saturated fats and sphingosine occurs in all tissues. Metabolic dysfunction and dyslipidemia results in accumulation of ceramides in tissues not suited for lipid storage. Elevated concentrations of circulating ceramides are associated with atherosclerotic plaque formation, ischemic heart disease, myocardial infarction, hypertension, stroke, type 2 diabetes mellitus, insulin resistance, and obesity.

 

Three specific ceramides have been identified as highly linked to cardiovascular disease and insulin resistance: N-palmitoyl-sphingosine (Cer16:0), N-stearoyl-sphingosine (Cer18:0), and N-nervonoyl-sphingosine(Cer24:1). A fourth ceramide, N-lignoceroyl-sphingosine (Cer24:0), is highly abundant in all individuals and is useful as a normalization factor for intra-individual variability of ceramide concentrations. Individuals with elevated plasma ceramides are at higher risk of major adverse cardiovascular events even after adjusting for age, gender, smoking status, and serum biomarkers such as low-density lipoprotein and high-density lipoprotein cholesterol, C-reactive protein and lipoprotein-associated phospholipase A2. Ceramide concentrations are reduced by current cardiovascular therapies including diet, exercise, statins, and proprotein convertase subtilisin/kexin type inhibitors.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

MI-Heart Ceramide Risk Score:

0-2 Lower risk

3-6 Moderate risk

7-9 Increased risk

10-12 Higher risk

Ceramide (16:0): 0.19-0.36 mcmol/L

Ceramide (18:0): 0.05-0.14 mcmol/L

Ceramide (24:1): 0.65-1.65 mcmol/L

Ceramide (16:0)/(24:0): <0.11

Ceramide (18:0)/(24:0): <0.05

Ceramide (24:1)/(24:0): <0.45

 

Reference values have not been established for patients who are less than 18 years of age.

 

Note: Ceramide (24:0) alone has not been independently associated with disease and will not be reported.

Interpretation
Provides information to assist in interpretation of the test results

Elevated plasma ceramides are associated with increased risk of myocardial infarction, acute coronary syndromes, and mortality within 1 to 5 years.

Ceramide Score

Relative Risk

Risk Category

0-2

1.0

Lower

3-6

1.5

Moderate

7-9

2.2

Increased

10-12

3.5

Higher

 

Score is based on trial data including >4000 subjects.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

No significant cautionary statements.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1 Laaksonen R, Ekroos K, Sysi-Aho M, et al. Plasma ceramides predict cardiovascular death in patients with stable coronary artery disease and acute coronary syndromes beyond LDL-cholesterol. Eur Heart J. 2016;37(25):1967-1976

2. Havulinna AS, Sysi-Aho M, Hilvo M, et al. Circulating ceramides predict cardiovascular outcomes in the population-based FINRISK 2002 cohort. Arterioscler Thromb Vasc Biol. 2016;36(12):2424-2430

3. Wang DD, Toledo E, Hruby A, et al. Plasma ceramides, Mediterranean diet, and incident cardiovascular disease in the PREDIMED trial (Prevenci on con Dieta Mediterranea). Circulation. 2017;135(21):2028-2040. doi:10.1161/CIRCULATIONAHA.116.024261

4. Meeusen JW, Donato LJ, Bryant SC, et al: Plasma Ceramides. Arterioscler Thromb Vasc Biol. 2018;38(8):1933-1939. doi:10.1161/ATVBAHA.118.311199

5. Peterson LR, Xanthakis V, Duncan MS, et al. Ceramide remodeling and risk of cardiovascular events and mortality. J Am Heart Assoc. 2018;7(10). doi:10.1161/JAHA.117.007931

6. Hilvo M, Meikle PJ, Pedersen ER, et al. Development and validation of a ceramide- and phospholipid-based cardiovascular risk estimation score for coronary artery disease patients. Eur Heart J. 2020;41(3):371-380. doi:10.1093/eurheartj/ehz387

7. Alshehry ZH, Mundra PA, Barlow CK, et al. Plasma lipidomic profiles improve on traditional risk factors for the prediction of cardiovascular events in type 2 diabetes mellitus. Circulation. 2016;134(21):1637-1650

8. Anroedh S, Hilvo M, Akkerhuis KM, et al. Plasma concentrations of molecular lipid species predict long-term clinical outcome in coronary artery disease patients. J Lipid Res. 2018;59(9):1729-1737. doi:10.1194/jlr.P081281

9. Lemaitre RN, Jensen PN, Hoofnagle A, et al. Plasma ceramides and sphingomyelins in relation to heart failure risk. Circ Heart Fail. 2019;12(7):e005708. doi:10.1161/CIRCHEARTFAILURE.118.005708

Method Description
Describes how the test is performed and provides a method-specific reference

Ceramides are separated and quantified by liquid chromatography tandem mass spectrometry (LC-MS/MS).(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday, Wednesday, Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 7 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

0119U

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
CERAM MI-Heart Ceramides, P 93883-7
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
42428 Ceramide (16:0) 93882-9
42429 Ceramide (18:0) 93881-1
42430 Ceramide (24:1) 93880-3
42431 Ceramide (16:0)/(24:0) ratio 93879-5
42432 Ceramide (18:0)/(24:0) ratio 93878-7
42433 Ceramide (24:1)/(24:0) ratio 93877-9
42434 MI-Heart Ceramide Risk Score 93876-1

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports