Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research (EISNER)

Coronary Artery Disease Clinical Trial

— EISNER  

Official title:

Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research (EISNER)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927693
• Other study ID #: 3351
• Status: Completed
• Phase: N/A
• First received: June 23, 2009
• Last updated: September 28, 2011
• Start date: February 2001
• Est. completion date: August 2010

Study information

• Verified date: September 2011
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2137
• Est. completion date: August 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	The Eisner Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		4 years	No