Clinical trial NCT00927693: Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research (EISNER)
Official title: Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research (EISNER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Coronary Artery Disease
Keywords: Atherosclerosis
Coronary Artery Disease
Cardiac Risk Factors
Coronary Calcium Scan
Prevention
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: The Eisner Foundation
First posted: 2009-06-25
Enrollment: 2137
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
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
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Daniel S. Berman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.