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Coronary Calcium Screening + Statins for Cardiovascular Prevention (CorCal Trial)
N/A
Recruiting
Led By Joseph B Muhlestein, MD
Research Sponsored by Intermountain Health Care, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No known history, as documented in the EHR, of coronary artery disease, cerebrovascular disease, peripheral vascular disease, or diabetes mellitus at enrollment
Be older than 18 years old
Must not have
Any evidence of statin use prior to study participation
Patients who have active on-going cancer or are on dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether a proactive cardiovascular prevention strategy, with or without coronary calcium screening, can prevent major adverse cardiac events better than current standard care.
Who is the study for?
This trial is for men aged 50-80 and women aged 60-80 with no history of cardiovascular disease or diabetes, who haven't used statins or had a coronary calcium test in the last 5 years. Participants must be able to provide electronic health records and understand study procedures.
What is being tested?
The study tests if proactive heart disease prevention strategies, including coronary artery calcium screening followed by statin treatment, can prevent major cardiac events better than standard care in people at moderate risk but without current heart disease.
What are the potential side effects?
Potential side effects may include those commonly associated with statins such as muscle pain, fatigue, digestive problems, and increased blood sugar levels which could lead to diabetes. The CT scan for calcium screening carries minimal risks like radiation exposure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have no history of heart, brain blood vessel, peripheral artery diseases, or diabetes.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have taken statins before joining the study.
Select...
I am currently undergoing dialysis or have active cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
MACE
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Proactive CAC GroupExperimental Treatment1 Intervention
Investigational Interventional Group. Will undergo coronary artery calcium screening and will receive statin recommendation based on the cardiovascular risk algorithm.
Group II: Proactive Current National Guidelines GroupActive Control1 Intervention
Standard Interventional Control Group. Will receive treatment recommendation according to the current National guidelines for statin initiation and follow-up.
Find a Location
Who is running the clinical trial?
Intermountain Health Care, Inc.Lead Sponsor
139 Previous Clinical Trials
1,954,960 Total Patients Enrolled
Joseph B Muhlestein, MDPrincipal InvestigatorIntermountain Medical Center
9 Previous Clinical Trials
32,779 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no history of heart, brain blood vessel, peripheral artery diseases, or diabetes.I am a man aged 50-80 or a woman aged 60-80.I have taken statins before joining the study.I am currently undergoing dialysis or have active cancer.I understand the study and agree to participate.I am willing and able to have a CT scan for heart artery calcium.
Research Study Groups:
This trial has the following groups:- Group 1: Proactive CAC Group
- Group 2: Proactive Current National Guidelines Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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