Biorepository: Indiana Health Study

Healthy Clinical Trial

— IHS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00741416
• Other study ID #: FI-08-US-0001
• Status: Recruiting
• Phase: N/A
• First received: August 25, 2008
• Last updated: June 30, 2011
• Start date: June 2008
• Est. completion date: June 2013

Study information

• Verified date: June 2011
• Source: Fairbanks Institute
• Contact: Mary Ann Caldwell, RNC CCRC
• Phone: 317-274-8915
• Email: macaldwe[@]iupui.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	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	Alivio Medical Center (spanish/espaniol)	Indianapolis	Indiana
United States	American Health Network	Indianapolis	Indiana
United States	Indiana Heart Hospital: Community Heart and Vascular Clinic	Indianapolis	Indiana
United States	Krannert Institute of Cardiology/IU Dept. of Medicine	Indianapolis	Indiana
United States	Oral Health Research Institute	Indianapolis	Indiana
United States	Outpatient Clinical Research Facility/Indiana Cancer Pavilion	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

Sponsors (5)

Lead Sponsor	Collaborator
Fairbanks Institute	BioCrossroads, Indiana University School of Medicine, Regenstrief Institute, Inc., Richard M. Fairbanks Foundation

Country where clinical trial is conducted

United States,