Database Registry of the Intermountain Heart Collaborativ... | NCT00406185

Studies
Database Registry of the Intermountain Heart Collaborative Study

NCT00406185

Sponsor

Intermountain Health Care, Inc.

Status

Active, not recruiting

Last Update Posted

Apr 14, 2026Actual

Enrollment

30,000Estimated

Phase

Not provided

Conditions

Coronary Artery Disease
Electrophysiology
Cardiovascular Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1994

Primary Completion Date

Mar 2027Estimated

Completion Date

Mar 2027Estimated

First Submitted Date

Nov 30, 2006

First Submission Date that Met QC Criteria

Nov 30, 2006

First Posted Date

Dec 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2026

Last Update Posted Date

Apr 14, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Outcome Risk	To evaluate risk factors, characteristics, and treatments to cardiovascular outcomes	30 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients undergoing a procedure within the catheterization laboratory

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph B Muhlestein, MD	Intermountain Healthcare, LDS Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intermountain Medical Center		Murray	Utah	84157	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9812073	Background	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.
21821014	Derived	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.

ID	Term
D003324	Coronary Artery Disease
D002318	Cardiovascular Diseases
D003327	Coronary Disease

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases