Validation of Simple Acute Coronary Syndrome (SACS) Score

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 12,000 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 Joseph's 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 (n=42), 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 Joseph's 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 patient's 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, BUN/Creatinine, 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, and/or proposals for
development of a hybrid scoring system will result from the analysis of this data.

Inclusion Criteria:

- Any patient presenting to the Cardiac Catheterization Lab during the study period.

Exclusion Criteria:

- Patients who refuse / wish to not be included in the study,

- Patients with Wolff-Parkinson-White syndrome with visible Delta waves on the ECG.

- Patients with Renal Failure and abnormally elevated Creatinine >2.0

- Patients with Potassium values >6.0