Trial record 2 of 3055 for:    Indiana Health

Biorepository: Indiana Health Study (IHS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Fairbanks Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Indiana University School of Medicine
Richard M. Fairbanks Foundation
BioCrossroads
Regenstrief Institute, IU Center for Aging Research
Information provided by:
Fairbanks Institute
ClinicalTrials.gov Identifier:
NCT00741416
First received: August 25, 2008
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

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.


Condition
Coronary Artery Disease
Heart Disease
Healthy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Collection and Storage of Human Biological Materials (Blood Sample) and Linked Phenotypic Information (Health History) for Research Purposes

Resource links provided by NLM:


Further study details as provided by Fairbanks Institute:

Biospecimen Retention:   Samples With DNA

70ml of whole blood: 3-10 ml EDTA tubes for collection of whole blood 3-10 ml SST tubes (red tops) for collection of serum 2-3ml PAXgene tubes for collection of RNA A minimum of 1 EDTA and 1 SST tube is required for enrollment into the study.


Estimated Enrollment: 1400
Study Start Date: June 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Case
Those with a diagnosis of Coronary Artery Disease
Control
Those who do not have Coronary Artery Disease (are healthy) but are matched to a Case participant by age, gender, and ethnicity.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741416

Contacts
Contact: Mary Ann Caldwell, RNC CCRC 317-274-8915 macaldwe@iupui.edu
Contact: Brooke McMillen 317-238-2483 bmcmillen@fairbanksinstitute.org

Locations
United States, Indiana
American Health Network Recruiting
Avon, Indiana, United States
Contact: Carla Cravens    317-745-8000 ext 453    carla_cravens@ahni.com   
Principal Investigator: Mary Schmoll, NP         
Investigator's Research Group Recruiting
Brownsburg, Indiana, United States
Contact: Rod Rapheal    317-297-7999    investigatorsresearch@yahoo.com   
Principal Investigator: Kenneth Maynard, DO         
American Health Network Recruiting
Franklin, Indiana, United States
Contact: Michelle Meier, LPN    317-738-7448    michelle_Meier@ahni.com   
Contact: Christine Wathen    317-738-7448    Christine_wathen@ahni.com   
Principal Investigator: Jill Beavins, MD         
American Health Network Recruiting
Greenfield, Indiana, United States
Contact: Vickie McDaniel, LPN    317-462-5252 ext 248    vickie_mcdaniel@ahni.com   
Principal Investigator: Stephanie Kinnaman, MD         
Indiana Heart Hospital: Community Heart and Vascular Clinic Recruiting
Indianapolis, Indiana, United States, 46219
Contact: Brenda Neuman, LPN    317-621-8628    bneuman@ecommunity.com   
Principal Investigator: DeoVrat Singh, MD         
Outpatient Clinical Research Facility/Indiana Cancer Pavilion Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Mary Ann Caldwell, RNC CCRC    317-554-5790    macaldwe@iupui.edu   
Contact: Brooke McMillen    317-238-2483    bmcmillen@fairbanksinstitute.org   
Principal Investigator: Anantha Shekhar, MD PhD         
Krannert Institute of Cardiology/IU Dept. of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jeri L Steward    317-962-0080    steward3@iupui.edu   
Sub-Investigator: Jacquelyn o'Donnell, MD         
Alivio Medical Center (spanish/espaniol) Recruiting
Indianapolis, Indiana, United States, 46222
Contact: Jorge Ayala    317-635-3499    jorfa@insightbb.com   
Contact: Alfredo Lopez, MD    317-635-3499      
Principal Investigator: Alfredo Lopez, MD         
Oral Health Research Institute Recruiting
Indianapolis, Indiana, United States
Contact: Melissa Mau    317-274-5439    mmau@iupui.edu   
Principal Investigator: Ana Gossweiler         
American Health Network Active, not recruiting
Indianapolis, Indiana, United States, 46254
Corvasc MDs Recruiting
Indianapolis (North), Indiana, United States
Contact: Sara Gallagher    317-583-7804    sgallagher@corvascmds.com   
Principal Investigator: Christopher Salerno, MD         
Indiana Heart Physicians Recruiting
Indianapolis (South), Indiana, United States
Contact: Molly Miller    317-893-1900    molly.miller@ssfhs.org   
Principal Investigator: Carl Rouch, MD         
IU Health Arnett Recruiting
Lafayette, Indiana, United States
Contact: Stephanie Middleton    765-448-8019    smiddle3@clarianarnett.com   
Principal Investigator: Dona Gray, MD         
Medical Consultants, PC Recruiting
Muncie, Indiana, United States
Contact: Sherri Adair    765-254-4761      
Principal Investigator: Bruce Graham, MD         
Sponsors and Collaborators
Fairbanks Institute
Indiana University School of Medicine
Richard M. Fairbanks Foundation
BioCrossroads
Regenstrief Institute, IU Center for Aging Research
Investigators
Principal Investigator: Anantha Shekhar, MD PhD Indiana University School of Medicine/CTSI
Study Director: Cynthia Helphingstine, PhD Fairbanks Institute for Healthy Communities
  More Information

Additional Information:
No publications provided

Responsible Party: Cynthia J. Helphingstine, Fairbanks Institute for Healthy Communities
ClinicalTrials.gov Identifier: NCT00741416     History of Changes
Other Study ID Numbers: FI-08-US-0001
Study First Received: August 25, 2008
Last Updated: June 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Fairbanks Institute:
Heart Disease
Biorepository
Biobank

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014