Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research (EISNER)

Study Overview
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Brief Summary
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Early Identification of Subclinical Atherosclerosis by Noninvasive Imaging Research (EISNER) is a multi-study research program being conducted at Cedars-Sinai Medical Center. The principal objective of this randomized trial (referred to as Study 1) is to assess whether coronary artery calcium (CAC) scanning provides clinical benefit thus improving patient outcomes in asymptomatic subjects with intermediate coronary artery disease (CAD) risk. Additionally, the study is designed to assess the value of combining the CAC scan with the Framingham risk score (FRS) and measurements of serum or plasma biomarkers to predict outcomes.

Detailed Description
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At baseline eligible subjects underwent a clinic visit where they were randomized 2:1 to a scan group which had complete cardiac risk assessment and CAC scanning or a no scan group which had only complete cardiac risk assessment. Both groups underwent a private counseling session with a trained nurse practitioner to review their results and receive customized health behavior suggestions based on current American Heart Association guidelines for primary prevention of heart disease. Subjects were followed up for changes in clinical status, medication use and specific health behaviors at one year after baseline. Annually for four years, subjects were followed up for subsequent diagnostic testing, therapy, and outcomes related to their cardiac health. At four years after baseline, all subjects (from both groups) returned for a repeat clinic visit to have a complete cardiac risk assessment and CAC scanning. Year 4 CAC scanning was performed in both the scan group and no scan group. Additional long-term followup is being conducted under a separate protocol.

Official Title
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Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research (EISNER)

Conditions
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Atherosclerosis, Coronary Artery Disease

Intervention / Treatment
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* Other: Coronary Artery Calcium (CAC) Scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No symptoms of CAD Intermediate risk of CAD, defined as either: male with age of 55-80 years or female with age 65-80 years or male of 45-54 years and at least one CAD risk factor or female with age 55-64 years and at least one CAD risk factor Risk factors include: smoking, high blood pressure, high total or LDL cholesterol, low HDL cholesterol, diabetes, family history of early CAD.) Exclusion Criteria: History of CVD including heart attack, cardiomyopathy, peripheral artery disease, angina, revascularization, and CVA (stroke) Prior coronary calcium scan or coronary angiogram Pregnancy Required radiation badges for work (CSMC Radiation Safety ruling) Clinically unstable health status or significant medical co-morbidity

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scan group<br>Scan group undergoes complete cardiac risk assessment and CAC scanning at baseline. | Other: Coronary Artery Calcium (CAC) Scan<br>* A coronary artery calcium (CAC) scan is performed during the baseline clinic visit. The results including the actual images from the scan are viewed by the subject during the risk factor consultation with the nurse practitioner. Results are available for the subjects' physicians upon request.<br>|
| No Intervention: No scan group<br>No scan group undergoes only complete cardiac risk assessment (without CAC scan) at baseline. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome measures include - Coronary artery calcium (CAC) score at Year 4 - CAD risk factors, Framingham Risk Score (FRS), and health behaviors at Year 4 - Adverse cardiac outcomes during follow-up |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis, Coronary Artery Disease, Cardiac Risk Factors, Coronary Calcium Scan, Prevention