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

September 28, 2011 updated by: Daniel S. Berman, Cedars-Sinai Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2137

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Collaborators

The Eisner Foundation

Investigators

  • Principal Investigator: Daniel S. Berman, M.D., Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

June 23, 2009

First Submitted That Met QC Criteria

June 23, 2009

First Posted (Estimate)

June 25, 2009

Study Record Updates

Last Update Posted (Estimate)

September 29, 2011

Last Update Submitted That Met QC Criteria

September 28, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3351

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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