Database Registry of the Intermountain Heart Collaborative Study

Active, not recruiting

• Conditions: Coronary Artery Disease; Cardiovascular Disease; Electrophysiology

• Registration Number: NCT00406185
• Lead Sponsor: 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.

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 Timeline

• Study Start: 1994-10
• Study First Submitted: 2006-11-30
• Study First Submitted QC: 2006-11-30
• Study First Posted: 2006-12-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome Risk	30 years	To evaluate risk factors, characteristics, and treatments to cardiovascular outcomes

Trial Locations

Locations (1)

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States