Status:
UNKNOWN
Biorepository: Indiana Health Study
Lead Sponsor:
Fairbanks Institute
Collaborating Sponsors:
Indiana University School of Medicine
Richard M. Fairbanks Foundation
Conditions:
Coronary Artery Disease
Heart Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 s...
Detailed Description
Study Aim: The purpose of this study is to create an extensively annotated bio-repository platform for hypothesis-driven research that will lead to advancements in the diagnosis, treatment and preven...
Eligibility Criteria
Inclusion
- 1\. 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT00741416
Start Date
June 1 2008
End Date
June 1 2013
Last Update
July 1 2011
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
American Health Network
Avon, Indiana, United States
2
Investigator's Research Group
Brownsburg, Indiana, United States
3
American Health Network
Franklin, Indiana, United States
4
American Health Network
Greenfield, Indiana, United States