Database Registry of the Intermountain Heart Collaborative Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Intermountain Health Care, Inc.
Sponsor:
Information provided by (Responsible Party):
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT00406185
First received: November 30, 2006
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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
Coronary Artery Disease
Electrophysiology
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Database Registry of the Intermountain Heart Collaborative Study

Resource links provided by NLM:


Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • Outcome Risk [ Time Frame: 30 years ] [ Designated as safety issue: No ]
    To evaluate risk factors, characteristics, and treatments to cardiovascular outcomes


Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 30000
Study Start Date: October 1994
Estimated Study Completion Date: January 2024
Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All patients undergoing a procedure within the catheterization laboratory

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406185

Contacts
Contact: Joseph B Muhlestein, MD 801-507-4760 brent.muhlestein@imail.org

Locations
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Joseph B Muhlestein, MD    801-507-4760    brent.muhlestein@imail.org   
Sub-Investigator: Jeffrey L Anderson, MD         
Sub-Investigator: John F Carlquist, PhD         
Sub-Investigator: Benjamin D Horne, PhD, MPH         
Sub-Investigator: Dale G Renlund, MD         
Sub-Investigator: Abdallah G Kfoury, MD         
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
Principal Investigator: Joseph B Muhlestein, MD Intermountain Healthcare, LDS Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT00406185     History of Changes
Other Study ID Numbers: 128-db1
Study First Received: November 30, 2006
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Intermountain Health Care, Inc.:
Registry
cardiac catheterization laboratory
coronary heart disease
cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014