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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Primary Prevention Strategy
• Intervention / Treatment: Other: Standard Treatment; Combination product: Coronary Artery Calcium Screening and Statin Treatment

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 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. After about the first 600 patients are enrolled, an interim meeting will occur to evaluate entry criteria and size to determine if any modifications to the protocol should occur.

• Study Type: Interventional
• Enrollment (Anticipated): 9000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patti Spencer; Phone Number: 801-507-4778; Email: patti.spencer@imail.org
• Study Contact Backup: Name: Joseph B Muhlestein, MD; Phone Number: 801-507-4701; Email: jbrent.muhlestein@imail.org

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84143
      • Recruiting
      • Intermountain Medical Center and Intermountain Clinics
      • Contact: Joseph B Muhlestein, MD; Phone Number: 801-507-4701; Email: brent.muhlestein@imail.org
      • Contact: Patti Spencer; Phone Number: 801-507-4778; Email: patti.spencer@imail.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients who have active on-going cancer or are on dialysis
2. Any evidence of statin use prior to study participation
3. Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study
4. Any evidence of a CAC test within the last 5 years prior to screening
5. The Study Doctor(s) determine(s) that the subject is not eligible for participation in this research study
6. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Proactive Current National Guidelines Group; Standard Interventional Control Group. Will receive treatment recommendation according to the current National guidelines for statin initiation and follow-up.	Other: Standard Treatment; Patients will be managed following the AHA/ACC guidelines for statin initiation and follow-up.
Experimental: Proactive CAC Group; 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; Will undergo coronary artery calcium screening and will receive statin treatment based on the cardiovascular risk algorithm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	Composite of all-cause mortality, myocardial infarction, stroke, and revascularization (coronary, carotid, and peripheral).	5 years

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2018
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: 1050633

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No