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

• ClinicalTrials.gov Identifier: NCT00927693
• Recruitment Status: Completed
• First Posted: June 25, 2009
• Last Update Posted: September 29, 2011
• Sponsor: Cedars-Sinai Medical Center
• Collaborator: The Eisner Foundation
• Information provided by (Responsible Party): Daniel S. Berman, Cedars-Sinai Medical Center

Tracking Information

• First Submitted Date: June 23, 2009
• First Posted Date: June 25, 2009
• Last Update Posted Date: September 29, 2011
• Study Start Date: February 2001
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research (EISNER)
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Atherosclerosis
• Coronary Artery Disease

Intervention

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

• 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 *

• Lin A, Wong ND, Razipour A, McElhinney PA, Commandeur F, Cadet SJ, Gransar H, Chen X, Cantu S, Miller RJH, Nerlekar N, Wong DTL, Slomka PJ, Rozanski A, Tamarappoo BK, Berman DS, Dey D. Metabolic syndrome, fatty liver, and artificial intelligence-based epicardial adipose tissue measures predict long-term risk of cardiac events: a prospective study. Cardiovasc Diabetol. 2021 Jan 29;20(1):27. doi: 10.1186/s12933-021-01220-x.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 23, 2009): 2137
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2010
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 45 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00927693
• Other Study ID Numbers: 3351
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Daniel S. Berman, Cedars-Sinai Medical Center
• Study Sponsor: Cedars-Sinai Medical Center
• Collaborators: The Eisner Foundation

Investigators

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

• PRS Account: Cedars-Sinai Medical Center
• Verification Date: September 2011