Validation of Simple Acute Coronary Syndrome (SACS) Score

Myocardial Infarction Clinical Trial

— SACS  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02358148
• Other study ID #: 521-0
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 3, 2015
• Last updated: July 18, 2016
• Start date: February 2015
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Bayfront Health St Petersburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina
• Chest Pain
• Infarction
• Myocardial Infarction
• Syndrome

Locations

Country	Name	City	State
United States	Bayfront Health Dade City	Dade City	Florida
United States	Bayfront Health St Petersburg	St Petersburg	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Bayfront Health St Petersburg	Bayfront Health Dade City, Community Health Systems (CHS)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Backus BE, Six AJ, Kelder JC, Bosschaert MA, Mast EG, Mosterd A, Veldkamp RF, Wardeh AJ, Tio R, Braam R, Monnink SH, van Tooren R, Mast TP, van den Akker F, Cramer MJ, Poldervaart JM, Hoes AW, Doevendans PA. A prospective validation of the HEART score for — View Citation

Macdonald SP, Nagree Y, Fatovich DM, Brown SG. Modified TIMI risk score cannot be used to identify low-risk chest pain in the emergency department: a multicentre validation study. Emerg Med J. 2014 Apr;31(4):281-5. doi: 10.1136/emermed-2012-201323. Epub 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic Findings of Cardiac Catheterization	Interventional Cardiologist's Diagnosis resulting from coronary angiography during Cardiac Catheterization - will determine which one of the following SECONDARY OUTCOME categories the patient is placed in:	30 days from enrollment	No
Secondary	No CAD noted - no coronary interventions indicated	Diagnostic coronary angiography reveals patient has no discernable coronary artery disease, no coronary artery interventions are indicated.	30 days from study enrollment	No
Secondary	Mild-moderate CAD noted - no coronary artery interventions are indicated	Diagnostic coronary angiography revealed one or more mild-moderate NON-Obstructive Lesion(s), no invasive intervention (PCI or CABG) indicated at current time.	30 days from study enrollment	No
Secondary	Obstructive CAD present, no myocardial injury, immediate intervention is indicated	Coronary angiography revealed significant Obstructive Lesion(s) present in one or more coronary artery. TIMI Grade III bloodflow is present, intervention (PCI or CABG revascularization) is indicated now.	30 days from study enrollment	Yes
Secondary	Obstructive CAD present with myocardial infarction/ injury	Coronary angiography revealed sub-total or total occlusion with	30 days from study enrollment	Yes
Secondary	No Obstructive CAD present but myocardial damage is evident	Coronary angiography reveals no obstructive CAD is present, but patient has sustained myocardial injury with decreased EF, consistent with vascular event such as vasospasm, Apical Balloon (Tako-Tsubo) Syndrome, Cocaine/Drug induced, or other myocardial injury.	30 days from study enrollment	Yes

External Links

•   Heart Score Netherlands - website