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

  • STATUS
    Recruiting
  • End date
    Apr 23, 2023
  • participants needed
    9000
  • sponsor
    Intermountain Health Care, Inc.
Updated on 23 January 2021

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.

Description

This is a randomized, open-label study designed to assess the effectiveness of coronary calcium screening. Patients who provide consent, and are eligible, will be randomized 1:1 to receive statin recommendation based on coronary calcium screening results or standard risk assessment results using the American Heart Association/American College of Cardiology (AHA/ACC)-recommended pooled cohort equation.

Management of all participants will be done through their primary care physicians/clinicians and their qualified delegates who will receive education and training from the Principal Investigator and/or his delegate about the two treatment strategies. The current National guidelines group will be managed following the AHA/ACC guidelines for statin initiation and follow-up. The coronary artery calcium (CAC) group will undergo coronary artery calcium screening and will receive a statin recommendation based on the proposed CAC cardiovascular (CV) risk algorithm. All subjects will be asked to complete the Intermountain Statin Adherence Questionnaire (ISAQ) at 3 months after recommendation (+ 60 days) and then annually thereafter (within +/- 60 days of the anniversary date of recommendation). All subjects will remain under the usual care of their primary care physicians and will be followed by the study team via their electronic health records (EHR) for approximately an average of 4 years following the subjects' anniversary date of recommendation, but until the target primary endpoint event rate is met. All enrolled subjects will be followed for outcomes and this will be completely done by electronic medical records query. Other than the time point to obtain agreement for study participation and to perform the CAC screening and/or lipid panel, there will be no other study-specific clinic visits required. Further, there will be no other treatments or procedures required for this study.

Details
Condition Cardiovascular Primary Prevention Strategy
Treatment Standard Treatment, Coronary Artery Calcium Screening and Statin Treatment
Clinical Study IdentifierNCT03439267
SponsorIntermountain Health Care, Inc.
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 50 yrs and 80 yrs?
Gender: Male or Female
Do you have Cardiovascular Primary Prevention Strategy?
Do you have any of these conditions: Do you have Cardiovascular Primary Prevention Strategy??
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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