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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Wayne Ruppert, St. Joseph's Hospital, Florida.
Recruitment status was:  Enrolling by invitation
ClinicalTrials.gov Identifier:
First Posted: July 28, 2009
Last Update Posted: April 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wayne Ruppert, St. Joseph's Hospital, Florida

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.

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

Further study details as provided by Wayne Ruppert, 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 ]

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)
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.

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947804

United States, Florida
St. Joseph's Hospital
Tampa, Florida, United States, 33607
Sponsors and Collaborators
St. Joseph's Hospital, Florida
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

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
First Submitted: July 26, 2009
First Posted: July 28, 2009
Last Update Posted: April 8, 2013
Last Verified: December 2012

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

Additional relevant MeSH terms:
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases