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Study to Validate Simple Acute Coronary Syndrome Score (SACS Score)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Wayne Ruppert, St. Joseph's Hospital, Florida
ClinicalTrials.gov Identifier:
NCT00947804
First received: July 26, 2009
Last updated: April 5, 2013
Last verified: December 2012
History of Changes
  Purpose

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.


Condition
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Phase 1 - Pilot Study to Validate the Simple Acute Coronary Syndrome Score; an Acute Coronary Syndrome (ACS) Risk Stratification Tool

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Joseph's Hospital, Florida:

Primary Outcome Measures:
  • PRESENCE or ABSENCE of obstructive CAD as discovered during non-investigative coronary angiography in the Cardiac Catheterization Lab. [ Time Frame: Within 24 hours of: a) arrival in Emergency Department, or b) admission to the hospital ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947804

Locations
United States, Florida
St. Joseph's Hospital
Tampa, Florida, United States, 33607
Sponsors and Collaborators
St. Joseph's Hospital, Florida
Investigators
Principal Investigator: Wayne W Ruppert, CVT St. Joseph's Hospital, Tampa, FL
Study Director: 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
  More Information

No publications provided

Responsible Party: Wayne Ruppert, Principal Investigator, St. Joseph's Hospital, Florida
ClinicalTrials.gov Identifier: NCT00947804     History of Changes
Other Study ID Numbers: ACS SACS Score SJH-01
Study First Received: July 26, 2009
Last Updated: April 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by St. Joseph's Hospital, Florida:
Acute Coronary Artery Syndrome Risk Stratification Score

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013