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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
Sponsor:
Collaborator:
The Eisner Foundation
Information provided by (Responsible Party):
Daniel S. Berman, Cedars-Sinai Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Atherosclerosis Coronary Artery Disease Other: Coronary Artery Calcium (CAC) Scan Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
The Eisner Foundation
Investigators
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Principal Investigator: Daniel S. Berman, M.D. Cedars-Sinai Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Daniel S. Berman, Chief Cardiac Imaging and Nuclear Medicine, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00927693    
Other Study ID Numbers: 3351
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: September 29, 2011
Last Verified: September 2011
Keywords provided by Daniel S. Berman, Cedars-Sinai Medical Center:
Atherosclerosis
Coronary Artery Disease
Cardiac Risk Factors
Coronary Calcium Scan
Prevention
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs