NCT00927693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,137

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

September 29, 2011

Status Verified

September 1, 2011

Enrollment Period

8.4 years

First QC Date

June 23, 2009

Last Update Submit

September 28, 2011

Conditions

AtherosclerosisCoronary Artery Disease

Keywords

AtherosclerosisCoronary Artery DiseaseCardiac Risk FactorsCoronary Calcium ScanPrevention

Outcome Measures

Primary Outcomes (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

    4 years

Study Arms (2)

Scan group

EXPERIMENTAL

"Scan" group undergoes complete cardiac risk assessment and CAC scanning at baseline.

Other: Coronary Artery Calcium (CAC) Scan

No scan group

NO INTERVENTION

"No scan" group undergoes only complete cardiac risk assessment (without CAC scan) at baseline.

Interventions

Coronary Artery Calcium (CAC) ScanOTHER

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.

Scan group

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (2)

  • 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.

    PMID: 33514365DERIVED

  • 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.

    PMID: 21439754DERIVED

MeSH Terms

Conditions

AtherosclerosisCoronary Artery Disease

Interventions

Carnitine Acyltransferases

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaHeart Diseases

Intervention Hierarchy (Ancestors)

AcyltransferasesTransferasesEnzymesEnzymes and Coenzymes

Study Officials

  • Daniel S. Berman, M.D.

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Cardiac Imaging and Nuclear Medicine

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 25, 2009

Study Start

February 1, 2001

Primary Completion

July 1, 2009

Study Completion

August 1, 2010

Last Updated

September 29, 2011

Record last verified: 2011-09

Locations

US(1)