Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research (EISNER)
NCT ID: NCT00927693
Last Updated: 2011-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2137 participants
INTERVENTIONAL
2001-02-28
2010-08-31
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Scan group
"Scan" group undergoes complete cardiac risk assessment and CAC scanning at baseline.
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 scan group
"No scan" group undergoes only complete cardiac risk assessment (without CAC scan) at baseline.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
80 Years
ALL
No
Sponsors
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The Eisner Foundation
UNKNOWN
Cedars-Sinai Medical Center
OTHER
Responsible Party
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Daniel S. Berman
Chief Cardiac Imaging and Nuclear Medicine
Principal Investigators
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Daniel S. Berman, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
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References
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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.
Other Identifiers
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3351
Identifier Type: -
Identifier Source: org_study_id