Ignite Creation Date:
2024-05-05 @ 9:41 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00947804
Status:
UNKNOWN
Last Update Posted:
2013-04-08
First Post:
2009-07-26
Brief Title:
Study to Validate Simple Acute Coronary Syndrome Score
Sponsor:
St Josephs Hospital Florida
Organization:
St Josephs Hospital Florida
Study Overview
Official Title:
Phase 1 - Pilot Study to Validate the Simple Acute Coronary Syndrome Score an Acute Coronary Syndrome ACS Risk Stratification Tool
Status:
UNKNOWN
Status Verified Date:
2012-12
Last Known Status:
ENROLLING_BY_INVITATION
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:
SACS Score
Brief Summary:
The Simple Acute Coronary Syndrome SACS Score was developed as a Risk Stratification Tool for Acute Coronary Syndrome ACS It is a tool which rates a patients SYMPTOMS EKG FINDINGS RISK FACTOR PROFILE and CARDIAC MARKERS on a scale of zero to six
The purpose of this study is to validate the SACS Scoring tool by establishing a correlation between the scores numerical values and the degree of obstructive cardiovascular disease visualized during cardiac catheterization
The purpose of this study is to validate the SACS Scoring tool by establishing a correlation between the scores numerical values and the degree of obstructive cardiovascular disease visualized during cardiac catheterization
Detailed Description:
Depending on whose published research is referenced an estimated 68000 to 136000 people with ACS are misdiagnosed and discharged annually from our nations emergency departments The emotional loss to grieving family members is incalculable The negative financial impact to families who lose their primary income providers and losses incurred by health care providers in legal expenses is also significant Misdiagnosis of ACS is due in part to
Patients presenting with ATYPICAL symptoms of ACS
Problems with SENSITIVITY and SPECIFICITY with the 12 Lead EKG
Inconsistent integration of Patients Coronary Artery Disease CAD Risk Factor Profile into the clinical decision making process
One solution to improving ACS diagnostic accuracy is for clinicians to utilize an ACS Risk Stratification Tool that is proven to be highly sensitive and specific with respect to identifying patients with significant underlying CAD
While screening approximately 50 patient case studies for inclusion in a 12 Lead EKG education curriculum multiple incidents were noted where the patients Modified TIMI ACS Risk Score did not accurately correlate with the patients degree of cardiovascular disease In several cases the disparity between the Modified TIMI Risk Score and the patients disease status was so great that if clinicians had considered this score in the clinical decision making process patients would have been discharged with clean bills of health while actually having severe underlying CAD scenarios that would have set the stage for adverse outcomes
In the search for a more reliable ACS Risk Stratification Tool none were found that were deemed consistently reliable enough for use as an adjunct to clinical decision making This could be due in part to the fact that the tools currently available TIMI GRACE PURSUIT were primarily designed as prognostic indicators of mortality in patients diagnosed with ST Segment Elevation Myocardial Infarction STEMI in pharmaceutical studies - not as tools to assess the probability that ACS exists in patients presenting to the Emergency Department This prompted the development of the SACS Score
In approximately 50 cases informally studied to date the SACS scoring tool produced scores that are more consistent and more predictive of the presence of obstructive CAD than the Modified TIMI Risk Score
Our formal study will consist of at least 200 patients which will include two groups
GROUP 1 will consist of all Acute Myocardial Infarction AMI patients STEMI NSTEMI treated at St Josephs Hospital beginning in January 2009 and continuing until our target number of 200 patients is obtained In order to not delay urgent cardiac catheterization and treatment these patients will be studied retrospectively post cardiac catheterization and intervention
GROUP 2 will consist of randomly selected patients whom are clinically stable at the time of cardiac catheterization These patients will be studied prospectively To maintain integrity of the study these patients will be selected with written consent obtained prior to cardiac catheterization
Data to be collected in all case studies both groups will include demographics and specific information about the patients SYMPTOMS EKG FINDINGS RISK FACTOR PROFILE and CARDIAC LABS
NOTE ADDED JULY 2010 To assure accuracy with respect to comparison of the SACS score to other ACS Risk Stratification scoring tools we will only include patients in our study whose medical records reflect accurate risk factor history assessments which are consistent with TIMI risk factor assessment guidelines For example if it is recorded that the patient has Family History Positive for Coronary Artery Disease but it does not state specifically WHICH family members andor does not state the SPECIFIC CARDIAC DIAGNOSIS such as Acute Myocardial Infarction andor does not include the AGE of the family member at the time of diagnosis we WILL NOT include the patient in our study A complete list of TIMI Risk Factor Assessment Guidelines TIMI guidelines can be found at wwwTIMIorg
POST CARDIAC CATHETERIZATION data will be classified into categories based on cath lab findings
1 No visible CAD present
2 Mild-to-moderate plaquing without obstructive CAD No catheter-based or surgical intervention was performed Number of lesions locations and percentages of arterial obstruction will be specified
3 Significant obstructive CAD present Number of lesions locations and percentages of arterial obstruction and interventions performed will be specified
4 Acute total occlusion of coronary artery requiring emergency intervention Location of lesion and interventions performed will be specified
Regression Analysis of 126 data points collected from each patient will be used to establish relationships between score values and the degree of obstructive CAD present
We believe that once scientifically validated the SACS Score will become a useful tool to aid medical professionals in reducing the incidence of patients whom are misdiagnosed with respect to ACS
Patients presenting with ATYPICAL symptoms of ACS
Problems with SENSITIVITY and SPECIFICITY with the 12 Lead EKG
Inconsistent integration of Patients Coronary Artery Disease CAD Risk Factor Profile into the clinical decision making process
One solution to improving ACS diagnostic accuracy is for clinicians to utilize an ACS Risk Stratification Tool that is proven to be highly sensitive and specific with respect to identifying patients with significant underlying CAD
While screening approximately 50 patient case studies for inclusion in a 12 Lead EKG education curriculum multiple incidents were noted where the patients Modified TIMI ACS Risk Score did not accurately correlate with the patients degree of cardiovascular disease In several cases the disparity between the Modified TIMI Risk Score and the patients disease status was so great that if clinicians had considered this score in the clinical decision making process patients would have been discharged with clean bills of health while actually having severe underlying CAD scenarios that would have set the stage for adverse outcomes
In the search for a more reliable ACS Risk Stratification Tool none were found that were deemed consistently reliable enough for use as an adjunct to clinical decision making This could be due in part to the fact that the tools currently available TIMI GRACE PURSUIT were primarily designed as prognostic indicators of mortality in patients diagnosed with ST Segment Elevation Myocardial Infarction STEMI in pharmaceutical studies - not as tools to assess the probability that ACS exists in patients presenting to the Emergency Department This prompted the development of the SACS Score
In approximately 50 cases informally studied to date the SACS scoring tool produced scores that are more consistent and more predictive of the presence of obstructive CAD than the Modified TIMI Risk Score
Our formal study will consist of at least 200 patients which will include two groups
GROUP 1 will consist of all Acute Myocardial Infarction AMI patients STEMI NSTEMI treated at St Josephs Hospital beginning in January 2009 and continuing until our target number of 200 patients is obtained In order to not delay urgent cardiac catheterization and treatment these patients will be studied retrospectively post cardiac catheterization and intervention
GROUP 2 will consist of randomly selected patients whom are clinically stable at the time of cardiac catheterization These patients will be studied prospectively To maintain integrity of the study these patients will be selected with written consent obtained prior to cardiac catheterization
Data to be collected in all case studies both groups will include demographics and specific information about the patients SYMPTOMS EKG FINDINGS RISK FACTOR PROFILE and CARDIAC LABS
NOTE ADDED JULY 2010 To assure accuracy with respect to comparison of the SACS score to other ACS Risk Stratification scoring tools we will only include patients in our study whose medical records reflect accurate risk factor history assessments which are consistent with TIMI risk factor assessment guidelines For example if it is recorded that the patient has Family History Positive for Coronary Artery Disease but it does not state specifically WHICH family members andor does not state the SPECIFIC CARDIAC DIAGNOSIS such as Acute Myocardial Infarction andor does not include the AGE of the family member at the time of diagnosis we WILL NOT include the patient in our study A complete list of TIMI Risk Factor Assessment Guidelines TIMI guidelines can be found at wwwTIMIorg
POST CARDIAC CATHETERIZATION data will be classified into categories based on cath lab findings
1 No visible CAD present
2 Mild-to-moderate plaquing without obstructive CAD No catheter-based or surgical intervention was performed Number of lesions locations and percentages of arterial obstruction will be specified
3 Significant obstructive CAD present Number of lesions locations and percentages of arterial obstruction and interventions performed will be specified
4 Acute total occlusion of coronary artery requiring emergency intervention Location of lesion and interventions performed will be specified
Regression Analysis of 126 data points collected from each patient will be used to establish relationships between score values and the degree of obstructive CAD present
We believe that once scientifically validated the SACS Score will become a useful tool to aid medical professionals in reducing the incidence of patients whom are misdiagnosed with respect to ACS
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