Test Id : CERAM
MI-Heart Ceramides, Plasma
    
        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.
                
            
    
    
    
        Reporting Name
            
                
                
                    
                    Lists a shorter or abbreviated version of the Published Name for a test
                
            
    
    
    
        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 | |
| Ambient | 8 hours | ||
| Refrigerated | 24 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
                
            
    
    
    
        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.
                
            
    
    
    
        Specimen Retention Time
            
                
                
                    
                    Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
                
            
    
    
    
        Performing Laboratory Location
            
                
                
                    
                    Indicates the location of the laboratory that performs the test
                
            
    
    
    
        Fees :
            
                
                
                    
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        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.
                
            
    
    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 |