Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00927693
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : September 29, 2011
Sponsor:
Collaborator:
The Eisner Foundation
Information provided by (Responsible Party):
Daniel S. Berman, Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE June 23, 2009
First Posted Date  ICMJE June 25, 2009
Last Update Posted Date September 29, 2011
Study Start Date  ICMJE February 2001
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research (EISNER)
Official Title  ICMJE Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research (EISNER)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Atherosclerosis
  • Coronary Artery Disease
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2009)
2137
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00927693
Other Study ID Numbers  ICMJE 3351
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel S. Berman, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Cedars-Sinai Medical Center
Collaborators  ICMJE The Eisner Foundation
Investigators  ICMJE
Principal Investigator: Daniel S. Berman, M.D. Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date September 2011

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