Ignite Creation Date:
2024-05-06 @ 3:42 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02358148
Status:
UNKNOWN
Last Update Posted:
2016-07-19
First Post:
2015-02-03
Brief Title:
Validation of Simple Acute Coronary Syndrome SACS Score
Sponsor:
Bayfront Health St Petersburg
Organization:
Bayfront Health St Petersburg
Study Overview
Official Title:
Validation of the Simple Acute Coronary Syndrome SACS Score and Head-to-Head Comparison of the SACS vs Modified TIMI vs HEART ACS Scores
Status:
UNKNOWN
Status Verified Date:
2016-07
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
Brief Summary:
This prospective observational study will evaluate and compare the sensitivity and specificity of the Modified TIMI HEART and SACS Scores for accurately predicting the presence and absence of obstructive coronary artery disease OCAD as diagnosed during coronary angiography in the cardiac catheterization suite In addition we plan to determine if a variant of SACS HEART TIMI or a hybrid score resulting from combining formulas from two or all three scores yields a new tool that exceeds the predictive performance of all three current models for determining the absence or presence of OCAD
Detailed Description:
HISTORY The Simple Acute Coronary Syndrome SACS Score was developed in 2009 by Cardiac Catheterization staff after noting what appeared to be an unacceptable volume of patients presenting with low Modified TIMI Scores 0-2 who were found to have severe Obstructive Coronary Artery Disease OCAD The SACS Scoring formula was derived by observing correlations in an estimated 12000 cases between patients SYMPTOMS ECG FINDINGS CAD RISK FACTOR PROFILES TROPONIN VALUES and the degree of OCAD discovered during coronary angiography
The primary objective of the SACS Score is to identify patients who are at high risk for OCAD with the intent that they will receive diagnostic and interventional measures prior to the occurence of Acute Myocardial Infarction AMI or other Major Adverse Coronary Event MACE
In a small pilot study conducted in 2009 at St Josephs Hospital in Tampa Florida the SACS Score demonstrated a trend of reliability superior to the Modified TIMI Score for accurately predicting the absence or presence of OCAD Because the sample size was deemed to be not statistically significant n42 the study team concluded that the SACS Score demonstrates a promising trend but additional data needs to be collected and analyzed before any definitive conclusions can be drawn
Since the advent of the St Josephs study another ACS MACE predictive tool the HEART Score was introduced by Backus and Six et al of the Netherlands The HEART Score has been scientifically validated by several studies with results published most recently in the International Journal of Cardiology 2013 Furthermore the studies demonstrated that HEART is superior to the Modified TIMI and GRACE Scores for accurately predicting the probability of MACE
It is interesting to note that the HEART Score closely resembles SACS with differences in the scoring formula for ECG findings and the patients age Our hypothesis is both scores will demonstrate superior predictability of OCAD but a hybrid combination of the HEART and SACS formulas may produce a scoring tool that will exceed all three in sensitivity and specificity for predicting the presence or absence of OCAD
STUDY END POINT for all patients is CARDIAC CATHETERIZATION The findings obtained during CORONARY ANGIOGRAPHY and the need for immediate intervention as dictated by the Interventional Cardiologist
DATA TO BE COLLECTED Patient symptoms history CAD risk factor profile 12 Lead ECG findings Lab results Troponin electrolytes BUNCreatinine BNP and all other data fields necessary to calculate a complete Modified TIMI HEART and SACS score Cardiac Cath Lab findings description of coronary angiography for each vessel and any Coronary Artery Interventions performed or recommended PCI CABG A STANDARDIZED DATA COLLECTION FORM has been developed and will be utilized for all patients
REGRESSION ANALYSIS will result from 126 data points collected from each patient encounter Relationships between score values and the degree of obstructive CAD present will be established along with p values and sensitivity specificity for each scoring system Recommendations for modifications to currently existing scores andor proposals for development of a hybrid scoring system will result from the analysis of this data
The primary objective of the SACS Score is to identify patients who are at high risk for OCAD with the intent that they will receive diagnostic and interventional measures prior to the occurence of Acute Myocardial Infarction AMI or other Major Adverse Coronary Event MACE
In a small pilot study conducted in 2009 at St Josephs Hospital in Tampa Florida the SACS Score demonstrated a trend of reliability superior to the Modified TIMI Score for accurately predicting the absence or presence of OCAD Because the sample size was deemed to be not statistically significant n42 the study team concluded that the SACS Score demonstrates a promising trend but additional data needs to be collected and analyzed before any definitive conclusions can be drawn
Since the advent of the St Josephs study another ACS MACE predictive tool the HEART Score was introduced by Backus and Six et al of the Netherlands The HEART Score has been scientifically validated by several studies with results published most recently in the International Journal of Cardiology 2013 Furthermore the studies demonstrated that HEART is superior to the Modified TIMI and GRACE Scores for accurately predicting the probability of MACE
It is interesting to note that the HEART Score closely resembles SACS with differences in the scoring formula for ECG findings and the patients age Our hypothesis is both scores will demonstrate superior predictability of OCAD but a hybrid combination of the HEART and SACS formulas may produce a scoring tool that will exceed all three in sensitivity and specificity for predicting the presence or absence of OCAD
STUDY END POINT for all patients is CARDIAC CATHETERIZATION The findings obtained during CORONARY ANGIOGRAPHY and the need for immediate intervention as dictated by the Interventional Cardiologist
DATA TO BE COLLECTED Patient symptoms history CAD risk factor profile 12 Lead ECG findings Lab results Troponin electrolytes BUNCreatinine BNP and all other data fields necessary to calculate a complete Modified TIMI HEART and SACS score Cardiac Cath Lab findings description of coronary angiography for each vessel and any Coronary Artery Interventions performed or recommended PCI CABG A STANDARDIZED DATA COLLECTION FORM has been developed and will be utilized for all patients
REGRESSION ANALYSIS will result from 126 data points collected from each patient encounter Relationships between score values and the degree of obstructive CAD present will be established along with p values and sensitivity specificity for each scoring system Recommendations for modifications to currently existing scores andor proposals for development of a hybrid scoring system will result from the analysis of this data
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