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Protocol - Lipid Profile

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Description:

Measure of plasma lipid levels in blood samples to predict risk for the development of heart attack or to define metabolic syndrome.

Protocol:

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.

Diagnostic Criteria:

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

Protocol Name from Source:

The Expert Review Panel has not reviewed this measure yet.

Availability:

Publicly available

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 "don't 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.

Equipment Needs

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.

Requirements
Requirement CategoryRequired
Major equipment Yes
Specialized training Yes
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

Life Stage:

Adult

Participants:

Coronary Artery Risk Development in Young Adults (CARDIA): ≥18 years old

Framingham Heart Study (FHS): ages 19–79 years old

Specific Instructions:

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.

Selection Rationale

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.

Language

English, Spanish

Standards
StandardNameIDSource
Common Data Elements (CDE) Person High Cholesterol Indicator 2936262 CDE Browser
Logical Observation Identifiers Names and Codes (LOINC) Lipid profile proto 62391-8 LOINC
Derived Variables

[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

The Expert Review Panel has not reviewed this measure yet.

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).

General References

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.

Protocol ID:

40201

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX040201_Age_Take_High_Blood_Cholesterol_Medication PX040201020200 At what age did you begin taking medicine for this? 4 N/A
PX040201_Age_Take_High_Blood_Cholesterol_Medication_Coded PX040201020201 At what age did you begin taking medicine for this? 4 N/A
PX040201_Ever_Have_High_Blood_Cholesterol PX040201010000 Has a doctor or nurse ever said that you have high blood cholesterol? 4 N/A
PX040201_Ever_Take_High_Blood_CholesteroL_Medication PX040201020100 Have you ever taken medication for high blood cholesterol? 4 N/A
PX040201_Lipid_Blood_Drawn PX040201030200 Interview: Was blood drawn successfully? 4 N/A
PX040201_Lipid_Consent PX040201030100 Interview: Was consent given? 4 N/A
PX040201_Lipid_Date PX040201040000 Date blood drawn for lipid profile (mm/dd/yyyy) 4 N/A
PX040201_Lipid_HDL PX040201080000 HDL from lipid profile 4 Variable Mapping
PX040201_Lipid_LDL PX040201070000 LDL from lipid profile 4 Variable Mapping
PX040201_Lipid_Requested PX040201030000 Interview: Was blood requested for lipid profile? 4 N/A
PX040201_Lipid_Time PX040201050000 Time blood drawn for lipid profile (hh:mm am/pm) 4 N/A
PX040201_Lipid_Total_Cholesterol PX040201060000 Total cholesterol from lipid profile 4 Variable Mapping
PX040201_Lipid_Triglyceride PX040201090000 Triglycerides from lipid profile 4 Variable Mapping
Research Domain Information
Measure Name:

Lipid Profile

Release Date:

September 9, 2009

Definition

Measure to identify lipid levels in samples of blood.

Purpose

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.

Keywords

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