INTRODUCTION: You are being asked to allow your child to participate in the Coronary Artery Risk Detection in Appalachian Communities (CARDIAC) Project research study.  This research is being conducted in an attempt to decrease the incidence and severity of cardiovascular diseases, diabetes and stroke in West Virginia.  The Project is supervised by William A. Neal, M.D., a children’s heart specialist on the faculty of West Virginia University, Department of Pediatrics.  He is working closely with local health care providers, school personnel and health science students who are learning about community-based public health.  The Project is supported by the West Virginia Bureau for Public Health and the West Virginia Legislature.

PURPOSES OF STUDY:   The purpose of this study is to learn more about heart disease risk factors in children as a means of determining which children and their  parents are at risk of developing early or premature coronary artery disease.  Early identification of cardiovascular risk factors will provide the opportunity to work with the child's family to reduce the risk of heart disease.  It is hoped that increased awareness of cardiovascular disease risk factors within the community will result in local strategies to promote wellness.

PROCEDURES:  Attached is a brief questionnaire about heart and diabetes risk factors in your family.  After completing this form, sign the form and have your child return this to the school.

During the screening, your child’s height, weight, and blood pressure will be measured.   The skin on the back of your child’s neck will be superficially examined for the thickened darker skin characteristic of the marker named Acanthosis Nigricans (AN), that may serve as an indicator for risk of Type 2 diabetes.  Your child will also have the opportunity to get a blood test used to identify other risks such as high cholesterol.  The blood test will require obtaining approximately a teaspoon of blood from a vein in the arm using a small needle.  There will be no additional discomfort. 

A voucher will be provided for you, the parent, to have a fasting blood test, performed at a local laboratory.  There is no cost for any of the testing.

The results of the screening day test will be made available to you by letter, including whether or not further consultation with your primary health care provider is recommended.  Some children may continue by participating in the Healthy Hearts Instructional Module or another CARDIAC related intervention by completing questionnaires or telephone interviews.  Questions about physical activity, nutrition and health beliefs may be included and you do not have to answer all the questions if you decide to participate.  

Approximately 20,000 5th grade students in all 55 West Virginia counties will be invited to participate.

BENEFITS:  You will find out if your child, and perhaps yourself, have major risk factors for heart disease.  Selected children may have glucose and insulin levels performed at the same time to determine their risk for diabetes.  This screening will enable treatment of these risk factors by your primary care provider.  Treatment usually requires a healthy diet and more physical activity.  Severely elevated cholesterol levels, especially if there is family history of early heart disease, may result in referral to a Special Children’s Lipid Clinic. Participation in this clinic is voluntary.

RISKS AND DISCOMFORTS:   There are no known serious risks or side effects related to the conduct of this project. There is mild discomfort when blood is drawn and there is also the risk of bruising, bleeding and rarely infection at the site where the blood is drawn.

FINANCIAL CONSIDERATION:    Those children and parents who participate in the screening will have these tests performed without charge.  If abnormal blood cholesterol values lead to referral of your child or yourself to your doctor, reimbursement for medical expenses will be according to usual and customary practice.

VOLUNTARY COMPENSATION: In the unlikely event that injury occurs as a result of this research, compensation will not be voluntarily provided by the investigators, sponsor, West Virginia University or other associated affiliates.

ALTERNATIVES:   An alternative to participate in the school screening would be not to participate.

CONTACT PERSONS:   In the unlikely event of injury or for more information about this research, you can contact Dr. William A. Neal at 304-293-4224, or after hours at 304-598-6000.  For information regarding your rights as a research subject, you may contact the Executive Secretary of the Institutional Review Board at 304-293-7073.

CONFIDENTIALITY:   Any information about you or your child obtained as a result of participation in this research will be kept as confidential as legally possible.  Research records, just like hospital records, may be subpoenaed by court order or may be inspected by federal regulatory authorities.  In any publications that result from this research, neither your child’s nor your name nor any information from which you might be identified will be published without your consent. 

VOLUNTARY PARTICIPATION:   Participation in this study is voluntary.  You are free to withdraw your  consent for participation in this study at any time.  Refusal to participate or withdrawal will involve no penalty or loss of benefits and will not affect your child’s grades or class standing.

Upon signing the attached form, you willingly consent for your child to participate in this research.

Sincerely,

William A. Neal, M.D., Director
CARDIAC Project

A current IRB is available in the CARDIAC office.