Effectiveness of a Proactive Cardiovascular Primary Prevention Strategy, With or Without the Use … (NCT03439267) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effectiveness of a Proactive Cardiovascular Primary Prevention Strategy, With or Without the Use of Coronary Calcium Screening, in Preventing Future Major Adverse Cardiac Events
United States5,765 participantsStarted 2018-03-26
Plain-language 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.
Who can participate
Age range50 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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