| Conditions: |
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Coronary Artery Disease - Heart Disease - Healthy |
| Purpose: |
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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.
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| Study Summary: |
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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.
Recruitment:
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.
Follow-up:
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.
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| Criteria: |
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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
greater
Exclusion Criteria:
1. 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)
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.
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| NCT ID: |
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NCT00741416 |
| Primary Contact: |
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Principal Investigator
Anantha Shekhar, MD PhD
Indiana University School of Medicine/CTSI
Mary Ann Caldwell, RNC CCRC
Phone: 317-274-8915
Email: macaldwe@iupui.edu
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| Backup Contact: |
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Email: bmcmillen@fairbanksinstitute.org
Brooke McMillen
Phone: 317-238-2483
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| Location Contact: |
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Indianapolis, Indiana 46219
United States
Brenda Neuman, LPN
Phone: 317-621-8628
Email: bneuman@ecommunity.com
Site Status: Recruiting |