Coronary Artery DiseaseIHSNCT00741416
Biorepository: Indiana Health Study
An observational study of Coronary Artery Disease and Heart Disease, run by Fairbanks Institute at 14 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Heart Disease, Healthy
- How many people
- 1,400 participants
- Where
- 14 sitesUnited States
- Study dates
- Jun 2008to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- History of stroke or Transient Ischemic Attacks (TIAs)
- 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
- 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.
- Subjects unwilling to consent to the allowance of future follow-up will be excluded from initial participation.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites, 13 recruiting
- Recruiting
American Health Network
Avon, Indiana
Carla Cravens, 317-745-8000 ext. 453, carla_cravens@ahni.com
Mary Schmoll, NP
- Recruiting
Investigator's Research Group
Brownsburg, Indiana
Rod Rapheal, 317-297-7999, investigatorsresearch@yahoo.com
Kenneth Maynard, DO
- Recruiting
American Health Network
Franklin, Indiana
Michelle Meier, LPN, 317-738-7448, michelle_Meier@ahni.com
Christine Wathen, 317-738-7448, Christine_wathen@ahni.com
- Recruiting
American Health Network
Greenfield, Indiana
Vickie McDaniel, LPN, 317-462-5252 ext. 248, vickie_mcdaniel@ahni.com
Stephanie Kinnaman, MD
- Recruiting
Krannert Institute of Cardiology/IU Dept. of Medicine
Indianapolis, Indiana, 46202
Jeri L Steward, 317-962-0080, steward3@iupui.edu
Jacquelyn o'Donnell, MD
- Recruiting
Outpatient Clinical Research Facility/Indiana Cancer Pavilion
Indianapolis, Indiana, 46202
Mary Ann Caldwell, RNC CCRC, 317-554-5790, macaldwe@iupui.edu
Brooke McMillen, 317-238-2483, bmcmillen@fairbanksinstitute.org
- Recruiting
Indiana Heart Hospital: Community Heart and Vascular Clinic
Indianapolis, Indiana, 46219
Brenda Neuman, LPN, 317-621-8628, bneuman@ecommunity.com
DeoVrat Singh, MD
- Recruiting
Alivio Medical Center (spanish/espaniol)
Indianapolis, Indiana, 46222
Jorge Ayala, 317-635-3499, jorfa@insightbb.com
Alfredo Lopez, MD, 317-635-3499
- Active, not recruiting
American Health Network
Indianapolis, Indiana, 46254
- Recruiting
Oral Health Research Institute
Indianapolis, Indiana
Melissa Mau, 317-274-5439, mmau@iupui.edu
Ana Gossweiler
- Recruiting
Corvasc MDs
Indianapolis (North), Indiana
Sara Gallagher, 317-583-7804, sgallagher@corvascmds.com
Christopher Salerno, MD
- Recruiting
Indiana Heart Physicians
Indianapolis (South), Indiana
Molly Miller, 317-893-1900, molly.miller@ssfhs.org
Carl Rouch, MD
- Recruiting
IU Health Arnett
Lafayette, Indiana
Stephanie Middleton, 765-448-8019, smiddle3@clarianarnett.com
Dona Gray, MD
- Recruiting
Medical Consultants, PC
Muncie, Indiana
Sherri Adair, 765-254-4761
Bruce Graham, MD
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Heart Disease, Healthy
- Keywords
- Heart Disease, Biorepository, Biobank
- Medical subject headings
- Coronary Artery Disease, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fairbanks Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, Richard M. Fairbanks Foundation, BioCrossroads, Regenstrief Institute, Inc.
- Investigators
- Anantha Shekhar, MD PhD, Principal investigator, Indiana University School of Medicine/CTSICynthia Helphingstine, PhD, Study director, Fairbanks Institute for Healthy Communities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741416
- Sponsor's protocol ID
- FI-08-US-0001
- Acronym
- IHS
- Status last verified
- Jun 2011
- First submitted
- 25 Aug 2008
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection and Storage of Human Biological Materials (Blood Sample) and Linked Phenotypic Information (Health History) for Research Purposes
- ClinicalTrials.gov ID
- NCT00741416
- Acronym / sponsor ID
- IHS / FI-08-US-0001
- Conditions
- Coronary Artery Disease, Heart Disease, Healthy
- Keywords
- Heart Disease, Biorepository, Biobank
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Fairbanks InstituteUniversity, hospital or other
- Collaborators
- Indiana University, Richard M. Fairbanks Foundation, BioCrossroads, Regenstrief Institute, Inc.
- Study start
- Jun 2008
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 26 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- Study subjects for the Control Group will be excluded based on a confirmed history of:
- Exclusion criteria for both the CAD Group and the Control Group will be a known or reported history of:
- 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.
- Subjects unwilling to consent to the allowance of future follow-up will be excluded from initial participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
- Information on The Fairbanks Institute for Health CommunitiesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anantha Shekhar, MD PhD principal investigator
Indiana University School of Medicine/CTSI
Cynthia Helphingstine, PhD study director
Fairbanks Institute for Healthy Communities
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Heart Disease, run by Fairbanks Institute at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary Ann Caldwell, RNC CCRC (317-274-8915, macaldwe@iupui.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2011.