Status:
ACTIVE_NOT_RECRUITING
Effectiveness of a Proactive Cardiovascular Primary Prevention Strategy, With or Without the Use of Coronary Calcium Screening, in Preventing Future Major Adverse Cardiac Events
Lead Sponsor:
Intermountain Health Care, Inc.
Conditions:
Cardiovascular Primary Prevention Strategy
Eligibility:
All Genders
50-80 years
Phase:
NA
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 s...
Detailed Description
This is a randomized, open-label, pragmatic study designed to assess the effectiveness of coronary calcium screening. Patients who provide consent, and are eligible, will be randomized 1:1 to receive ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2027
Estimated Enrollment :
5765 Patients enrolled
Trial Details
Trial ID
NCT03439267
Start Date
March 26 2018
End Date
May 1 2027
Last Update
May 6 2025
Active Locations (1)
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1
Intermountain Medical Center and Intermountain Clinics
Murray, Utah, United States, 84143