Ignite Creation Date:
2024-05-05 @ 9:37 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00927693
Status:
COMPLETED
Last Update Posted:
2011-09-29
First Post:
2009-06-23
Brief Title:
Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research EISNER
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research EISNER
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EISNER
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
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
Detailed Description:
At baseline eligible subjects underwent a clinic visit where they were randomized 21 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None