Effectiveness of a Proactive Cardiovascular Primary Prevention Strategy, With or Without the Use of Coronary Calcium Screening, in Preventing Future Major Adverse Cardiac Events

NCT03439267 | Active Not Recruiting DMC

• 1 other identifier: 1050633
• Study Type: interventional
• Target: 5,765
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to test the effectiveness of a proactive cardiovascular primary prevention strategy, with or without the use of coronary calcium screening, compared to current standard care, in preventing future major adverse cardiac events (MACE), including all-cause death, non-fatal myocardial infarction (MI), stroke, or any arterial revascularization among a moderate risk population with no current evidence of cardiovascular disease.

Conditions

Cardiovascular Primary Prevention Strategy

Outcome Measures

Primary Outcomes (1)

• MACE

  Composite of all-cause mortality, myocardial infarction, stroke, and revascularization (coronary, carotid, and peripheral).

  5 years

Study Arms (2)

Proactive Current National Guidelines Group

ACTIVE COMPARATOR

Standard Interventional Control Group. Will receive treatment recommendation according to the current National guidelines for statin initiation and follow-up.

Other: Standard Treatment

Proactive CAC Group

EXPERIMENTAL

Investigational Interventional Group. Will undergo coronary artery calcium screening and will receive statin recommendation based on the cardiovascular risk algorithm.

Combination Product: Coronary Artery Calcium Screening and Statin Treatment

Interventions

Standard Treatment OTHER

Patients will be managed following the AHA/ACC guidelines for statin initiation and follow-up.

Proactive Current National Guidelines Group

Coronary Artery Calcium Screening and Statin Treatment COMBINATION_PRODUCT

Will undergo coronary artery calcium screening and will receive statin treatment based on the cardiovascular risk algorithm.

Proactive CAC Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male subjects 50 to 80 years of age or female subjects 60 to 80 years of age, of any ethnic origin
• Ability to understand and provide agreement to study participation, which must be obtained prior to initiation of any study procedures
• No known history, as documented in the EHR, of coronary artery disease, cerebrovascular disease, peripheral vascular disease, or diabetes mellitus at enrollment
• Willing and able to provide access to their EHR until study end
• Willing and able to undergo a computed tomography (CT) coronary artery calcium screening test
• Current and/or past patients seen at Intermountain facilities and who have accessible EHR at the facility(ties) where they are seen.

You may not qualify if:

• Patients who have active on-going cancer or are on dialysis
• Any evidence of statin use prior to study participation
• Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study
• Any evidence of a CAC test within the last 5 years prior to screening
• The Study Doctor(s) determine(s) that the subject is not eligible for participation in this research study
• The subject is non-English speaking, and therefore may be unable to fully understand the written and spoken instructions that may relate to the proper conduct of the trial

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Medical Center and Intermountain Clinics

Murray, Utah, 84143, United States

Location

Related Publications (1)

• Muhlestein JB, Knowlton KU, Le VT, Lappe DL, May HT, Min DB, Johnson KM, Cripps ST, Schwab LH, Braun SB, Bair TL, Anderson JL. Coronary Artery Calcium Versus Pooled Cohort Equations Score for Primary Prevention Guidance: Randomized Feasibility Trial. JACC Cardiovasc Imaging. 2022 May;15(5):843-855. doi: 10.1016/j.jcmg.2021.11.006. Epub 2021 Dec 15.

  PMID: 34922872 DERIVED

Study Officials

• Joseph B Muhlestein, MD

  Intermountain Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: February 20, 2018
• Study Start: March 26, 2018
• Primary Completion: April 6, 2026
• Study Completion (Estimated): April 6, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)