Biorepository: Indiana Health Study

Status unconfirmed

Conditions studied: Coronary Artery Disease, Heart Disease, Healthy

In brief

Blood samples and health information (e.g., age at diagnosis, test results) are collected for the purposes of genetic research. The blood samples are assigned a number and stored in a repository for safe keeping until they are needed for a research project. Participants are persons who are healthy (not having high blood pressure, diabetes, or high cholesterol levels) or persons who have Coronary Artery Disease (CAD) and live in Indiana. Participants complete a questionnaire at the time the blood sample is drawn and are contacted once a year to update their health history. Researchers apply to the Fairbanks Institute for use of the blood samples and health information minus participant names and contact information. Their research is required to be related to find genes or substances made by genes that may be involved in Coronary Artery Disease with the purpose of improving the investigators understanding of the illness potentially leading to the development of new diagnostic tools for identifying the illness, new treatments,or preventative measures. This study will be repeated for other disorders like Diabetes and Cancer.

Key facts

Study ID

NCT00741416

Run by

Fairbanks Institute

People needed

1400

Starts

2008-06-01

Expected to finish

2013-06-01

Last updated by the study team

2011-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Study subjects will be recruited for the CAD group based on a history confirmed by the medical record of at least one of the following:
• Angioplasty, with or without stent placement
• Coronary Artery Bypass Graft (CABG) surgery
• Diagnostic angiogram or positive catheterization results showing 50% occlusion or greater

You may not qualify if…

• Study subjects for the Control Group will be excluded based on a confirmed history of:
• CAD as defined above, or as history of a positive stress test for ischemia, Troponin > 0.5 or myocardial infarction
• Diabetes (type 1 or 2)
• Hypertension (confirmed with at least two documented measurements of blood pressure greater than 140/90, not attributed to treating medications)
• Abnormal lipid profile defined as LDL-C < 130mg/dl, HDL ≥ 40 mg/dl, cholesterol < 240 mg/dl or triglycerides < 200 mg/dl
• Patients taking any medications commonly used for the above excluded conditions
• History of stroke or Transient Ischemic Attacks (TIAs)
• Exclusion criteria for both the CAD Group and the Control Group will be a known or reported history of:
• Hepatitis B
• Hepatitis C
• AIDS (HIV positive)
• Tuberculosis
• Cancer (including melanoma, but excluding low-malignancy skin cancer)
• Non-autologous bone marrow transplant
• Blood transfusion within 120 days
• In addition, prisoners, minors, patients requiring the consent of a caregiver or Authorized Representative, and/or any subjects deemed medically unsuitable for research donation by their treating physician (for reasons such as anemia, hematopoetic disorders/cancers or low body weight) will be excluded from the study.
• Subjects unwilling to consent to the allowance of future follow-up will be excluded from initial participation.

Where it is running

• Medical Consultants, PC — Muncie, Indiana, United States (enrolling)
• Investigator's Research Group — Brownsburg, Indiana, United States (enrolling)
• American Health Network — Franklin, Indiana, United States (enrolling)
• American Health Network — Greenfield, Indiana, United States (enrolling)
• Krannert Institute of Cardiology/IU Dept. of Medicine — Indianapolis, Indiana, United States (enrolling)
• Outpatient Clinical Research Facility/Indiana Cancer Pavilion — Indianapolis, Indiana, United States (enrolling)
• Indiana Heart Hospital: Community Heart and Vascular Clinic — Indianapolis, Indiana, United States (enrolling)
• Alivio Medical Center (spanish/espaniol) — Indianapolis, Indiana, United States (enrolling)
• American Health Network — Avon, Indiana, United States (enrolling)
• Oral Health Research Institute — Indianapolis, Indiana, United States (enrolling)
• Corvasc MDs — Indianapolis (North), Indiana, United States (enrolling)
• Indiana Heart Physicians — Indianapolis (South), Indiana, United States (enrolling)
• IU Health Arnett — Lafayette, Indiana, United States (enrolling)
• American Health Network — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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