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.

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withdrawn by the subject.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.