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Collection and Storage of Human Biological Materials (Blood Sample) and Linked Phenotypic Information (Health History) for Research Purposes

18 Years
Open (Enrolling)
Coronary Artery Disease, Heart Disease, Healthy

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Trial Information

Collection and Storage of Human Biological Materials (Blood Sample) and Linked Phenotypic Information (Health History) for Research Purposes

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
prevention of diseases common to the population of Indiana. The first phase of this research
platform will be created by collecting blood samples from two groups of individuals in the
Central Indiana community, one with documented evidence of coronary artery disease (CAD),
and a second group of age, gender and ethnicity matched individuals without clinical
evidence of CAD. Each individual's blood sample will be linked to their clinical,
demographic and epidemiological information, gathered both retrospectively and
prospectively. This will be repeated with individuals who have Cancer, Diabetes and
potentially other illnesses.


This initial study will include 750 individuals with CAD (the CAD Group) and 750 individuals
who are age, gender, and ethnicity matched to the CAD Group, but without presentation of
clinical evidence of CAD (the Control Group). To reflect the growing representation of
Hispanics in Central Indiana, Hispanics will be overly recruited in both groups so that the
study population accurately reflects the general population of Central Indiana.


As this is a prospective, longitudinal study, follow-up of study subjects is intended to
continue indefinitely, unless, of course, at any time, consent for further follow-up is
withdrawn by the subject. Follow-up will include continuing access to the subject's medical
record, as well as facilitating continued contact by telephone, to pursue data concerning
changes in the subject's health. Subjects may be contacted by telephone, mail or email every
twelve months to ask if they wish to continue participation in the study.

The collected dataset (made up of the collected blood samples linked to clinical and
epidemiological information collected retrospectively and prospectively), will be used in
medical research to find genes, or gene products such as RNA or proteins that will help in
understanding the causes of disease and will guide the development of new treatments.

Inclusion Criteria:

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

Exclusion Criteria:

1. Study subjects for the Control Group will be excluded based on a confirmed history

- 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)

2. 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

3. 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.

4. Subjects unwilling to consent to the allowance of future follow-up will be excluded
from initial participation.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Principal Investigator

Anantha Shekhar, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University School of Medicine/CTSI


United States: Institutional Review Board

Study ID:




Start Date:

June 2008

Completion Date:

June 2013

Related Keywords:

  • Coronary Artery Disease
  • Heart Disease
  • Healthy
  • Heart Disease
  • Biorepository
  • Biobank
  • Coronary Artery Disease
  • Myocardial Ischemia
  • Coronary Disease
  • Heart Diseases



Medical Consultants, PCMuncie, Indiana  47304
American Health NetworkIndianapolis, Indiana  46202
Investigator's Research GroupBrownsburg, Indiana  
Indiana Heart Hospital: Community Heart and Vascular ClinicIndianapolis, Indiana  46219
Outpatient Clinical Research Facility/Indiana Cancer PavilionIndianapolis, Indiana  46202
Krannert Institute of Cardiology/IU Dept. of MedicineIndianapolis, Indiana  46202
Alivio Medical Center (spanish/espaniol)Indianapolis, Indiana  46222
Oral Health Research InstituteIndianapolis, Indiana  
Corvasc MDsIndianapolis (North), Indiana  
Indiana Heart PhysiciansIndianapolis (South), Indiana  
IU Health ArnettLafayette, Indiana