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

Sponsor

Cedars-Sinai Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00927693

Collaborator

The Eisner Foundation (Other)

2,137

Enrollment

Location

Arms

113.9

Duration (Months)

18.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Coronary Artery Disease	Other: Coronary Artery Calcium (CAC) Scan	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

2137 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2001

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Scan group "Scan" group undergoes complete cardiac risk assessment and CAC scanning at baseline.	Other: Coronary Artery Calcium (CAC) Scan 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.
No Intervention: No scan group "No scan" group undergoes only complete cardiac risk assessment (without CAC scan) at baseline.

Arm

Intervention/Treatment

Experimental: Scan group

"Scan" group undergoes complete cardiac risk assessment and CAC scanning at baseline.

Other: Coronary Artery Calcium (CAC) Scan

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.

No Intervention: No scan group

"No scan" group undergoes only complete cardiac risk assessment (without CAC scan) at baseline.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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