Recruiting

BiorepositoryBiorepository: Indiana Health Study

Sponsor:

Fairbanks Institute

Code:

NCT00741416

Conditions

Coronary Artery Disease

Heart Disease

Healthy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Coronary Artery Disease

Heart Disease

Healthy

Study ID

NCT00741416

Start date

Jun, 2008

Status verified date

Jun, 2011

Completion date

Jun, 2013

Anticipated

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

1400 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Central Contacts and Locations

Central contacts

Mary Ann Caldwell, RNC CCRC

317-274-8915 macaldwe@iupui.edu

Brooke McMillen

317-238-2483 bmcmillen@fairbanksinstitute.org

Locations

American Health Network

Recruiting

Avon, Indiana, United States

Contacts

Carla Cravens

317-745-8000 carla_cravens@ahni.com

Principal Investigator:

Mary Schmoll, NP

Investigator's Research Group

Recruiting

Brownsburg, Indiana, United States

Contacts

Rod Rapheal

317-297-7999 investigatorsresearch@yahoo.com

Principal Investigator:

Kenneth Maynard, DO

American Health Network

Recruiting

Franklin, Indiana, United States

Contacts

Michelle Meier, LPN

317-738-7448 michelle_Meier@ahni.com

Christine Wathen

317-738-7448 Christine_wathen@ahni.com

Principal Investigator:

Jill Beavins, MD

American Health Network

Recruiting

Greenfield, Indiana, United States

Contacts

Vickie McDaniel, LPN

317-462-5252 vickie_mcdaniel@ahni.com

Principal Investigator:

Stephanie Kinnaman, MD

Corvasc MDs

Recruiting

Indianapolis (North), Indiana, United States

Contacts

Sara Gallagher

317-583-7804 sgallagher@corvascmds.com

Principal Investigator:

Christopher Salerno, MD

Indiana Heart Physicians

Recruiting

Indianapolis (South), Indiana, United States

Contacts

Molly Miller

317-893-1900 molly.miller@ssfhs.org

Principal Investigator:

Carl Rouch, MD

Krannert Institute of Cardiology/IU Dept. of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Jeri L Steward

317-962-0080 steward3@iupui.edu

Outpatient Clinical Research Facility/Indiana Cancer Pavilion

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Mary Ann Caldwell, RNC CCRC

317-554-5790 macaldwe@iupui.edu

Brooke McMillen

317-238-2483 bmcmillen@fairbanksinstitute.org

Principal Investigator:

Anantha Shekhar, MD PhD

Indiana Heart Hospital: Community Heart and Vascular Clinic

Recruiting

Indianapolis, Indiana, United States, 46219

Contacts

Brenda Neuman, LPN

317-621-8628 bneuman@ecommunity.com

Principal Investigator:

DeoVrat Singh, MD

Alivio Medical Center (spanish/espaniol)

Recruiting

Indianapolis, Indiana, United States, 46222

Contacts

Jorge Ayala

317-635-3499 jorfa@insightbb.com

Alfredo Lopez, MD

317-635-3499

Principal Investigator:

Alfredo Lopez, MD

Oral Health Research Institute

Recruiting

Indianapolis, Indiana, United States

Contacts

Melissa Mau

317-274-5439 mmau@iupui.edu

Principal Investigator:

Ana Gossweiler

IU Health Arnett

Recruiting

Lafayette, Indiana, United States

Contacts

Stephanie Middleton

765-448-8019 smiddle3@clarianarnett.com

Principal Investigator:

Dona Gray, MD

Medical Consultants, PC

Recruiting

Muncie, Indiana, United States

Contacts

Sherri Adair

765-254-4761

Principal Investigator:

Bruce Graham, MD

More Information

Sponsor

Fairbanks Institute

Last update posted

Jul 1, 2011

Last verified

Jun, 2011

Keywords

Heart Disease
Biorepository
Biobank

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Fairbanks Institute on 2011-07-01.