Coronary Artery DiseaseNCT00406185
Database Registry of the Intermountain Heart Collaborative Study
An observational study of Coronary Artery Disease and Electrophysiology, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
The purpose of the registry is to collect and analyze clinical and laboratory data and tissue samples from patients who are diagnosed with any type of heart disease and to collect the same information and samples from healthy controls in participating Intermountain Healthcare facilities. 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, Electrophysiology, Cardiovascular Disease
- How many people
- 30,000 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1994to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients undergoing a procedure within the catheterization laboratory
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the registry is to collect and analyze clinical and laboratory data and tissue samples from patients who are diagnosed with any type of heart disease and to collect the same information and samples from healthy controls in participating Intermountain Healthcare facilities.
Read the 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.
- Keywords
- Registry, cardiac catheterization laboratory, coronary heart disease, cardiovascular disease
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases, Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Risk
To evaluate risk factors, characteristics, and treatments to cardiovascular outcomes
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startOct 1994
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph B Muhlestein, MD, Principal investigator, Intermountain Healthcare, LDS Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406185
- Sponsor's protocol ID
- 128-db1
- Status last verified
- Apr 2026
- First submitted
- 30 Nov 2006
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 9812073Lappe 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.
PubMed 21821014Horne 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.
PubMed 20705688Horne 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.
PubMed 19486718Horne 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.
PubMed 18805103Horne 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.
PubMed 17512363
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Database Registry of the Intermountain Heart Collaborative Study
- ClinicalTrials.gov ID
- NCT00406185
- Acronym / sponsor ID
- 128-db1
- Keywords
- Registry, cardiac catheterization laboratory, coronary heart disease, cardiovascular disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- Oct 1994
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 4 Dec 2006 (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.
The purpose of the registry is to collect and analyze clinical and laboratory data and tissue samples from patients who are diagnosed with any type of heart disease and to collect the same information and samples from healthy controls in participating Intermountain Healthcare facilities.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing a procedure within the catheterization laboratory
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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
Outcome Risk
Time frame: 30 years
To evaluate risk factors, characteristics, and treatments to cardiovascular outcomes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Background: PubMed 9812073Taylor 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.
- Derived from this study: PubMed 21821014Lappe 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.
- Derived from this study: PubMed 20705688Horne 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.
- Derived from this study: PubMed 19486718Horne 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.
- Derived from this study: PubMed 18805103Horne 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.
- Derived from this study: PubMed 17512363Horne 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.
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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.
Joseph B Muhlestein, MD principal investigator
Intermountain Healthcare, LDS Hospital
1 site 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 Electrophysiology, run by Intermountain Health Care, Inc. at 1 site 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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome Risk (time frame: 30 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00406185, which also lists 6 linked publications.
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 14 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.