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临床试验/NCT02358148
NCT02358148Unknown不适用

Validation of the Simple Acute Coronary Syndrome (SACS) Score and Head-to-Head Comparison of the SACS vs. Modified TIMI vs. HEART ACS Scores

Bayfront Health St Petersburg2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
2
主要终点
Angiographic Findings of Cardiac Catheterization

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Angiographic Findings of Cardiac Catheterization

时间窗: 30 days from enrollment

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:

次要结局

  • Obstructive CAD present, no myocardial injury, immediate intervention is indicated(30 days from study enrollment)
  • Obstructive CAD present with myocardial infarction/ injury(30 days from study enrollment)
  • No CAD noted - no coronary interventions indicated(30 days from study enrollment)
  • Mild-moderate CAD noted - no coronary artery interventions are indicated(30 days from study enrollment)
  • No Obstructive CAD present but myocardial damage is evident(30 days from study enrollment)

研究者

发起方
Bayfront Health St Petersburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wayne Ruppert

Cardiac Data Specialist and Cardiovascular Clinical Coordinator

Bayfront Health St Petersburg

研究点 (2)

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