Healthy Clinical Trial
Official title:
Collection and Storage of Human Biological Materials (Blood Sample) and Linked Phenotypic Information (Health History) for Research Purposes
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.
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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Observational Model: Case Control, Time Perspective: Prospective
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