Protocol - Lipid Profile
Measure of plasma lipid levels in blood samples to predict risk for the development of heart attack or to define metabolic syndrome.
If the respondent answers "yes" to question 1, then the interviewer will proceed to question 2. The use of lipid-lowering medications must be captured, as the use of medications can have profound and predictable effects on the lipid levels and obscure the levels and phenotype of hyperlipidemia. Lipid profiles involving triglyceride-level measurement should be collected after an 8–12 hour fast. Generally, total cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides should be measured in a laboratory that is certified and referenced to a regional reference laboratory.
1. Has a doctor or nurse ever said that you have high blood cholesterol?
[ ] 1 No
[ ] 2 Yes
[ ] 8 Not sure
2. Have you ever taken medication for high blood cholesterol?
[ ] 0 No
[ ] 1 Yes, now
[ ] 2 Yes, not now
[ ] 9 unk
If yes, then…
At what age did you begin taking medicine for this? __ __
[ ] 99 unk
Use appropriate or current lipid quality control program to complete a lipid profile.
For information on blood collection and processing, and lipid and lipoprotein determinations, refer to the Atherosclerosis Risk in Communities (ARIC) study manuals 7 and 8.
|Total Cholesterol (mg/dL)||LDL Cholesterol (mg/dL)||HDL Cholesterol (mg/dL)||Triglyceride (mg/dL)|
|<200 = Desirable||<100 = Optimal||<40 = Low||<150 = Normal|
|200 - 239 = Borderline high||100 - 129 = Near optimal/above optimal||>60 = High||150 - 199 = Borderline high|
|>240 = High||130 - 159 = Borderline high||200 - 499 = High|
|160 - 189 = High||>500 = Very high|
|>190 = Very high|
Personnel and Training Required
An interviewer who is trained to conduct personal interviews with individuals from the general population is required. The interviewer must be trained and found to be competent (i.e., tested by an expert) at the completion of personal interviews.* The interviewer should be trained to prompt respondents further if a "dont know" response is provided.
*There are multiple modes to administer this question (e.g., paper-and-pencil and computer-assisted interviews).
The blood draw and processing procedures should be performed by a certified laboratory technician or a phlebotomist.
For the blood draw procedure, you will need the following: disposable plastic gloves; a test tube rack; three sterile, disposable 21 gauge butterfly needles; a plastic vacutainer tube guide; three vacutainer Luer slip adaptors; sterile alcohol swabs; gauze sponges; a tourniquet; bandages ("Band-Aids"); a styrofoam ice water bath; biohazard bags; a stopwatch; and eight blood collection tubes (13 ml red and gray stoppered tube, 7 ml siliconized red stoppered tube, 7 ml red and yellow stoppered tube, two 4.5 ml blue stoppered tubes, two 10 ml lavender stoppered tubes, 3 ml lavender stoppered tube).
For the blood handling and processing you will need: a freezer/refrigerator; a centrifuge; three 12 x 75 mm clear white polypropylene test tubes; three 1.5 ml yellow polypropylene microsample tubes; three 1.5 ml red polypropylene microsample tubes; one 1.5 ml green polypropylene microsample tube; six 1.5 ml blue polypropylene microsample tubes; twelve 2 ml white polypropylene screw top vials; ten lavender screw caps for 2 ml vials; two brown screw caps for 2 ml vials; one Millipore Millex HA-4 filter; one 5 ml syringe; one Centricon 30 molecular filter; and six plastic transfer pipets.
For shipping specimens, you will need the following: four 3" x 6" storage bags and one 6" x 6" storage bag; appropriately labeled styrofoam boxes.
|Specialized requirements for biospecimen collection||Yes|
|Average time of greater than 15 minutes in an unaffected individual||No|
Mode of Administration
Interviewer-administered question, Clinical/laboratory measurement
Coronary Artery Risk Development in Young Adults (CARDIA): ≥18 years old
Framingham Heart Study (FHS): ages 19–79 years old
These protocols were selected because together they obtain a personal history of high blood cholesterol as well as medication usage. These two components are vital in interpreting the results of a lipid profile. Completion of a lipid profile provides specificity to determine risk of a heart attack or stroke.
|caDSR Common Data Elements (CDE)||Person High Cholesterol Indicator||2936262||CDE Browser|
|Logical Observation Identifiers Names and Codes (LOINC)||Lipid profile proto||62391-8||LOINC|
|Human Phenotype Ontology||Abnomality lipoprotein cholesterol concentration||HP:0010979||HPO|
[LDL-cholesterol] = [total cholesterol] - [HDL-cholesterol] - [triglycerides/5]
The calculation is valid for triglycerides less than or equal to 400 mg/dl.
Centers for Disease Control and Prevention (CDC). (2008). National Health and Nutrition Examination Survey 2005–2006 documentation, codebook, and frequencies: Triglyceride, LDL-cholesterol and apolipoprotein (ApoB). Page 2.
Retrieved July 21, 2009, from http://www.cdc.gov/nchs/data/nhanes/nhanes_05_06/trigly_d.pdf
Process and Review
Protocol Name from Source
U.S. Department of Health and Human Services. National Institutes of Health. National Heart, Lung and Blood Institute. Coronary Artery Risk Development in Young Adults (CARDIA) Study. Y20 CARDIA VII. Medical History Form. Page 1. Question 2 (source for question 1 in Protocol Text).
U.S. Department of Health and Human Services. National Institutes of Health. National Heart, Lung and Blood Institute and Boston University. Framingham Heart Study (FHS). Generation 3. Exam 1. Medical History—Medications. Page 23. No question number provided (source for question 2 in Protocol Text).
U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, National Heart, Lung and Blood Institute. (2002). Third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III) final report. Retrieved on July 21, 2009, from http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3full.pdf (source for Diagnostic Criteria).
U.S. Department of Health and Human Services. National Institutes of Health. National Heart, Lung and Blood Institute. Atherosclerosis Risk in Communities Study (ARIC), Manual 7—Blood Collection.
U.S. Department of Health and Human Services. National Institutes of Health. National Heart, Lung and Blood Institute. Atherosclerosis Risk in Communities Study (ARIC), Manual 8—Lipid and Lipoprotein Determinations.
|Variable Name||Variable ID||Variable Description||dbGaP Mapping|
|PX040201020200||At what age did you begin taking medicine more||Variable Mapping|
|PX040201020201||At what age did you begin taking medicine more||Variable Mapping|
|PX040201010000||Has a doctor or nurse ever said that you more||Variable Mapping|
|PX040201020100||Have you ever taken medication for high more||Variable Mapping|
|PX040201030200||Interview: Was blood drawn successfully?||Variable Mapping|
|PX040201030100||Interview: Was consent given?||N/A|
|PX040201040000||Date blood drawn for lipid profile (mm/dd/yyyy)||Variable Mapping|
|PX040201080000||HDL from lipid profile||Variable Mapping|
|PX040201070000||LDL from lipid profile||Variable Mapping|
|PX040201030000||Interview: Was blood requested for lipid profile?||N/A|
|PX040201050000||Time blood drawn for lipid profile (hh:mm am/pm)||N/A|
|PX040201060000||Total cholesterol from lipid profile||Variable Mapping|
|PX040201090000||Triglycerides from lipid profile||Variable Mapping|
September 9, 2009
Measure to identify lipid levels in samples of blood.
A lipid profile is used to determine if an individual is at risk for the development of coronary heart disease (CHD). A lipid profile has been shown to be a good indicator of risk for a heart attack or stroke caused by blockage of blood vessels or hardening of the arteries.
Cardiovascular, Lipid Profile, heart attack, stroke, high blood cholesterol, Coronary Artery Risk Development in Young Adults, CARDIA, Framingham Heart Study, FHS, National Cholesterol Education Program, NCEP, Cholesterol, HDL, LDL, triglyceride, lipid, blood cholesterol, blood lipids, plasma, lipoprotein, hyperlipidemia, personal history, metabolic syndrome