Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research (EISNER) (EISNER)
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|ClinicalTrials.gov Identifier: NCT00927693|
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : September 29, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis Coronary Artery Disease||Other: Coronary Artery Calcium (CAC) Scan||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||2137 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research (EISNER)|
|Study Start Date :||February 2001|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||August 2010|
Experimental: Scan group
"Scan" group undergoes complete cardiac risk assessment and CAC scanning at baseline.
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.
No Intervention: No scan group
"No scan" group undergoes only complete cardiac risk assessment (without CAC scan) at baseline.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927693
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Daniel S. Berman, M.D.||Cedars-Sinai Medical Center|