- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00406185
Database Registry of the Intermountain Heart Collaborative Study
Study Overview
Status
Detailed Description
This is a registry (database) project; there are no investigational treatments, drug or procedures associated with participation in registry activities. This project is an organized data gathering and storing (database) endeavor with specific focus on the precursors, modifiers, biological, and genetic parameters of heart disease and related medical conditions. Data collection will not immediately influence the course of treatment for any patient.Sample testing and data utilization for basic science, clinical, and epidemiologic and publication projects can be initiated using the databank.
The registry will enable researchers to determine best medical practices for predicting, preventing, and treating heart disease. The registry will: 1) develop standard methods to collect data and specimens which will be used for research to characterize patients diagnosed with heart disease as well as healthy controls and to assess differences in demographics and patient outcomes in both populations; 2) collect, process, and store patients' clinical data and tissue/blood samples; 3) analyze data collected; 4) use these resources to identify genes, genetic polymorphisms, genetic mutations, clinical methods and procedures, and/or biomarkers that predict, prevent, or treat heart disease and/or are associated correlate with lifestyle or disease outcomes; 5) publish and disseminate results.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Utah
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Murray, Utah, United States, 84157
- Intermountain Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- The patient (male or non-pregnant female) must be > 18 years of age.
- The patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local Institutional Review Board.
Exclusion Criteria:
- Neither patient nor patient representative understands spoken English.
- Neither patient nor the patient's personal representative is willing to give written consent for participation.
- Healthy control patients must sign their own consent document.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Outcome Risk
Time Frame: 30 years
|
To evaluate risk factors, characteristics, and treatments to cardiovascular outcomes
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30 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joseph B Muhlestein, MD, Intermountain Healthcare, LDS Hospital
Publications and helpful links
General Publications
- Taylor GS, Muhlestein JB, Wagner GS, Bair TL, Li P, Anderson JL. Implementation of a computerized cardiovascular information system in a private hospital setting. Am Heart J. 1998 Nov;136(5):792-803. doi: 10.1016/s0002-8703(98)70123-1.
- Lappe JM, Horne BD, Shah SH, May HT, Muhlestein JB, Lappe DL, Kfoury AG, Carlquist JF, Budge D, Alharethi R, Bair TL, Kraus WE, Anderson JL. Red cell distribution width, C-reactive protein, the complete blood count, and mortality in patients with coronary disease and a normal comparison population. Clin Chim Acta. 2011 Nov 20;412(23-24):2094-9. doi: 10.1016/j.cca.2011.07.018. Epub 2011 Jul 27.
- Horne BD, May HT, Kfoury AG, Renlund DG, Muhlestein JB, Lappe DL, Rasmusson KD, Bunch TJ, Carlquist JF, Bair TL, Jensen KR, Ronnow BS, Anderson JL. The Intermountain Risk Score (including the red cell distribution width) predicts heart failure and other morbidity endpoints. Eur J Heart Fail. 2010 Nov;12(11):1203-13. doi: 10.1093/eurjhf/hfq115. Epub 2010 Aug 12.
- Horne BD, May HT, Muhlestein JB, Ronnow BS, Lappe DL, Renlund DG, Kfoury AG, Carlquist JF, Fisher PW, Pearson RR, Bair TL, Anderson JL. Exceptional mortality prediction by risk scores from common laboratory tests. Am J Med. 2009 Jun;122(6):550-8. doi: 10.1016/j.amjmed.2008.10.043.
- Horne BD, May HT, Anderson JL, Kfoury AG, Bailey BM, McClure BS, Renlund DG, Lappe DL, Carlquist JF, Fisher PW, Pearson RR, Bair TL, Adams TD, Muhlestein JB; Intermountain Heart Collaborative Study. Usefulness of routine periodic fasting to lower risk of coronary artery disease in patients undergoing coronary angiography. Am J Cardiol. 2008 Oct 1;102(7):814-819. doi: 10.1016/j.amjcard.2008.05.021. Epub 2008 Jul 10.
- Horne BD, Camp NJ, Anderson JL, Mower CP, Clarke JL, Kolek MJ, Carlquist JF; Intermountain Heart Collaborative Study Group. Multiple less common genetic variants explain the association of the cholesteryl ester transfer protein gene with coronary artery disease. J Am Coll Cardiol. 2007 May 22;49(20):2053-60. doi: 10.1016/j.jacc.2007.02.039. Epub 2007 May 4.
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 128-db1
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