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

Not Applicable

Completed

• Conditions: Atherosclerosis; Coronary Artery Disease
• Interventions: Other: Coronary Artery Calcium (CAC) Scan

• Registration Number: NCT00927693
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2001-02
• Study First Submitted: 2009-06-23
• Study First Submitted QC: 2009-06-23
• Study First Posted: 2009-06-25
• Primary Completion: 2009-07
• Study Completion: 2010-08
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-28
• Last Update Posted: 2011-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2137

Inclusion Criteria

• No symptoms of CAD

• Intermediate risk of CAD, defined as either:

  1. male with age of 55-80 years or female with age 65-80 years or

  2. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scan group	Coronary Artery Calcium (CAC) Scan	"Scan" group undergoes complete cardiac risk assessment and CAC scanning at baseline.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States