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

Cardiovascular Primary Prevention Strategy Clinical Trial

— CorCal  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03439267
• Other study ID #: 1050633
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2018
• Est. completion date: April 2024

Study information

• Verified date: August 2022
• Source: Intermountain Health Care, Inc.
• Contact: Joseph B Muhlestein, MD
• Phone: 801-507-4701
• Email: jbrent.muhlestein[@]imail.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9000
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Primary Prevention Strategy

Intervention

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.

Other:
• Standard Treatment
Patients will be managed following the AHA/ACC guidelines for statin initiation and follow-up.

Locations

Country	Name	City	State
United States	Intermountain Medical Center and Intermountain Clinics	Murray	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	Composite of all-cause mortality, myocardial infarction, stroke, and revascularization (coronary, carotid, and peripheral).	5 years