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Database Registry of the Intermountain Heart Collaborative Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00406185
Recruitment Status : Active, not recruiting
First Posted : December 4, 2006
Last Update Posted : August 10, 2022
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

Brief 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.

Condition or disease
Coronary Artery Disease Electrophysiology Cardiovascular Disease

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.

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Study Type : Observational
Estimated Enrollment : 30000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Database Registry of the Intermountain Heart Collaborative Study
Study Start Date : October 1994
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Primary Outcome Measures :
  1. Outcome Risk [ Time Frame: 30 years ]
    To evaluate risk factors, characteristics, and treatments to cardiovascular outcomes

Biospecimen Retention:   Samples With DNA
whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing a procedure within the catheterization laboratory

Inclusion Criteria:

  1. The patient (male or non-pregnant female) must be > 18 years of age.
  2. 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:

  1. Neither patient nor patient representative understands spoken English.
  2. Neither patient nor the patient's personal representative is willing to give written consent for participation.
  3. Healthy control patients must sign their own consent document.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00406185

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United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
Sponsors and Collaborators
Intermountain Health Care, Inc.
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Principal Investigator: Joseph B Muhlestein, MD Intermountain Healthcare, LDS Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT00406185    
Other Study ID Numbers: 128-db1
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: August 10, 2022
Last Verified: August 2022
Keywords provided by Intermountain Health Care, Inc.:
cardiac catheterization laboratory
coronary heart disease
cardiovascular disease
Additional relevant MeSH terms:
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Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arterial Occlusive Diseases
Vascular Diseases