Study to Validate Simple Acute Coronary Syndrome Score

NCT00947804 | Unknown DMC

• 1 other identifier: ACS SACS Score SJH-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary Artery Syndrome Risk Stratification Score

Outcome Measures

Primary Outcomes (1)

• PRESENCE or ABSENCE of obstructive CAD as discovered during non-investigative coronary angiography in the Cardiac Catheterization Lab.

  Within 24 hours of: a) arrival in Emergency Department, or b) admission to the hospital

Study Arms (2)

1. Patients with symptoms of ACS

Patients whom present emergently to the Cardiac Catheterization Lab with current symptoms of Acute Coronary Syndrome (ACS), whom at the time of admission to the cardiac catheterization lab are believed to be suffering from STEMI, NSTEMI, or Unstable Angina, with the possible need for emergency Percutaneous Coronary Intervention (PCI), or Coronary Artery Bypass Grafting (CABG).

2. Patients without symptoms of ACS

Non-emergency patients presenting to the Cardiac Catheterization Lab for elective coronary angiography, and possible PCI. These are patients whom may have experienced typical or atypical ACS symptoms intermittently, and have elected to have cardiac catheterization to rule out obstructive CAD. Patients in this group will be selected randomly, with consent obtained, prior to cardiac catheterization.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients presenting to the cardiac catherization suite whom have experienced ACS symptoms within the past thirty days.

You may qualify if:

• Must be mentally competent with ability to articulate symptoms and risk factor profile

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Hospital, Florida: lead

Study Sites (1)

St. Joseph's Hospital

Tampa, Florida, 33607, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Wayne W Ruppert, CVT

  St. Joseph's Hospital, Tampa, FL

  PRINCIPAL INVESTIGATOR

• Humberto Coto, MD, FACC

  St. Joseph's Hostpial, Tampa, Florida

  STUDY DIRECTOR

• Xavier E Prida, MD, FACC

  St. Joseph's Hospital, Tampa, Florida

  STUDY DIRECTOR

• Charles Sand, MD, FACEP

  St. Joesph's Hospital, Tampa, FL

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2009
• First Posted: July 28, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: April 8, 2013

Record last verified: 2012-12

Locations

US (1)