Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research (EISNER) (EISNER)
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Purpose
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 | Intervention |
|---|---|
|
Atherosclerosis Coronary Artery Disease |
Other: Coronary Artery Calcium (CAC) Scan |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research (EISNER) |
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 2137 |
| Study Start Date: | February 2001 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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| Ages Eligible for Study: | 45 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- No symptoms of CAD
-
Intermediate risk of CAD, defined as either:
- male with age of 55-80 years or female with age 65-80 years or
-
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Daniel S. Berman, Chief Cardiac Imaging and Nuclear Medicine, Cedars-Sinai Medical Center |
| ClinicalTrials.gov Identifier: | NCT00927693 History of Changes |
| Other Study ID Numbers: | 3351 |
| Study First Received: | June 23, 2009 |
| Last Updated: | September 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cedars-Sinai Medical Center:
|
Atherosclerosis Coronary Artery Disease Cardiac Risk Factors Coronary Calcium Scan Prevention |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Atherosclerosis Heart Diseases Cardiovascular Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Calcium, Dietary Bone Density Conservation Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 23, 2016