Clinical trial NCT00741416: Biorepository: Indiana Health Study
Official title: Collection and Storage of Human Biological Materials (Blood Sample) and Linked Phenotypic Information (Health History) for Research Purposes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Heart Disease
Healthy
Keywords: Heart Disease
Biorepository
Biobank
Lead sponsor: Fairbanks Institute
Sponsor class: OTHER
Collaborators: name: Indiana University School of Medicine
name: Richard M. Fairbanks Foundation
name: BioCrossroads
name: Regenstrief Institute, Inc.
First posted: 2008-08-26
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Avon
country: United States
facility: American Health Network
state: Indiana
city: Brownsburg
country: United States
facility: Investigator's Research Group
state: Indiana
city: Franklin
country: United States
facility: American Health Network
state: Indiana
city: Greenfield
country: United States
facility: American Health Network
state: Indiana
city: Indianapolis (North)
country: United States
facility: Corvasc MDs
state: Indiana
city: Indianapolis (South)
country: United States
facility: Indiana Heart Physicians
state: Indiana
city: Indianapolis
country: United States
facility: Krannert Institute of Cardiology/IU Dept. of Medicine
state: Indiana
city: Indianapolis
country: United States
facility: Outpatient Clinical Research Facility/Indiana Cancer Pavilion
state: Indiana
city: Indianapolis
country: United States
facility: Indiana Heart Hospital: Community Heart and Vascular Clinic
state: Indiana
city: Indianapolis
country: United States
facility: Alivio Medical Center (spanish/espaniol)
state: Indiana
city: Indianapolis
country: United States
facility: American Health Network
state: Indiana
city: Indianapolis
country: United States
facility: Oral Health Research Institute
state: Indiana
city: Lafayette
country: United States
facility: IU Health Arnett
state: Indiana
city: Muncie
country: United States
facility: Medical Consultants, PC
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine/CTSI
name: Anantha Shekhar, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fairbanks Institute for Healthy Communities
name: Cynthia Helphingstine, PhD
role: STUDY_DIRECTOR
References: