Phase 1 - Pilot Study to Validate the Simple Acute Coronary Syndrome Score; an Acute Coronary Syndrome (ACS) Risk Stratification Tool
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- PRESENCE or ABSENCE of obstructive CAD as discovered during non-investigative coronary angiography in the Cardiac Catheterization Lab.
研究概览
简要总结
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 patient's: 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 score's numerical values and the degree of obstructive cardiovascular disease visualized during cardiac catheterization.
详细描述
Depending on whose published research is referenced, an estimated 68,000 to 136,000 people with ACS are misdiagnosed and discharged annually from our nation's 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 patient's Modified TIMI ACS Risk Score did not accurately correlate with the patient's degree of cardiovascular disease. In several cases, the disparity between the Modified TIMI Risk Score and the patient's 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be mentally competent with ability to articulate symptoms and risk factor profile
排除标准
- •Renal disease
- •When unable to obtain all required data sets (SYMPTOMS, EKG, TIMI RISK FACTOR PROFILES, CARDIAC LABS)
- •EKG displays DELTA WAVES consistent with Wolff-Parkinson-White Syndrome
结局指标
主要结局
PRESENCE or ABSENCE of obstructive CAD as discovered during non-investigative coronary angiography in the Cardiac Catheterization Lab.
时间窗: Within 24 hours of: a) arrival in Emergency Department, or b) admission to the hospital
次要结局
未报告次要终点
研究者
Wayne Ruppert
Principal Investigator
St. Joseph's Hospital, Florida