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

This study has been completed.
Sponsor:
Collaborator:
The Eisner Foundation
Information provided by (Responsible Party):
Daniel S. Berman, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00927693
First received: June 23, 2009
Last updated: September 28, 2011
Last verified: September 2011

June 23, 2009
September 28, 2011
February 2001
July 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00927693 on ClinicalTrials.gov Archive Site
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Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research (EISNER)
Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research (EISNER)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Atherosclerosis
  • Coronary Artery Disease
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.
  • Experimental: Scan group
    "Scan" group undergoes complete cardiac risk assessment and CAC scanning at baseline.
    Intervention: Other: Coronary Artery Calcium (CAC) Scan
  • No Intervention: No scan group
    "No scan" group undergoes only complete cardiac risk assessment (without CAC scan) at baseline.
Rozanski A, Gransar H, Shaw LJ, Kim J, Miranda-Peats L, Wong ND, Rana JS, Orakzai R, Hayes SW, Friedman JD, Thomson LE, Polk D, Min J, Budoff MJ, Berman DS. Impact of coronary artery calcium scanning on coronary risk factors and downstream testing the EISNER (Early Identification of Subclinical Atherosclerosis by Noninvasive Imaging Research) prospective randomized trial. J Am Coll Cardiol. 2011 Apr 12;57(15):1622-32. doi: 10.1016/j.jacc.2011.01.019.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2137
August 2010
July 2009   (final data collection date for primary outcome measure)

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
Both
45 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00927693
3351
Not Provided
Daniel S. Berman, Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
The Eisner Foundation
Principal Investigator: Daniel S. Berman, M.D. Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP