Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1400 participants
OBSERVATIONAL
2008-06-30
2013-06-30
Brief Summary
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Detailed Description
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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study subjects is intended to continue indefinitely, unless, of course, at any time, consent for further follow-up is withdrawn by the subject.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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case
Those with a diagnosis of Coronary Artery Disease
No interventions assigned to this group
Control
Those who do not have Coronary Artery Disease (are healthy) but are matched to a Case participant by age, gender, and ethnicity.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
* 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.
18 Years
ALL
Yes
Sponsors
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Indiana University School of Medicine
OTHER
Richard M. Fairbanks Foundation
OTHER
BioCrossroads
OTHER
Regenstrief Institute, Inc.
OTHER
Fairbanks Institute
OTHER
Responsible Party
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Fairbanks Institute for Healthy Communities
Principal Investigators
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Anantha Shekhar, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine/CTSI
Cynthia Helphingstine, PhD
Role: STUDY_DIRECTOR
Fairbanks Institute for Healthy Communities
Locations
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American Health Network
Avon, Indiana, United States
Investigator's Research Group
Brownsburg, Indiana, United States
American Health Network
Franklin, Indiana, United States
American Health Network
Greenfield, Indiana, United States
Krannert Institute of Cardiology/IU Dept. of Medicine
Indianapolis, Indiana, United States
Outpatient Clinical Research Facility/Indiana Cancer Pavilion
Indianapolis, Indiana, United States
Indiana Heart Hospital: Community Heart and Vascular Clinic
Indianapolis, Indiana, United States
Alivio Medical Center (spanish/espaniol)
Indianapolis, Indiana, United States
American Health Network
Indianapolis, Indiana, United States
Oral Health Research Institute
Indianapolis, Indiana, United States
Corvasc MDs
Indianapolis (North), Indiana, United States
Indiana Heart Physicians
Indianapolis (South), Indiana, United States
IU Health Arnett
Lafayette, Indiana, United States
Medical Consultants, PC
Muncie, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Alfredo Lopez, MD
Role: backup
Sherri Adair
Role: primary
Related Links
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Information on The Fairbanks Institute for Health Communities
Other Identifiers
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FI-08-US-0001
Identifier Type: -
Identifier Source: org_study_id
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