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Trial record 1 of 1 for:    NCT02358148
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Validation of Simple Acute Coronary Syndrome (SACS) Score (SACS)

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02358148
First Posted: February 6, 2015
Last Update Posted: July 19, 2016
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.
Collaborators:
Bayfront Health Dade City
Community Health Systems (CHS)
Information provided by (Responsible Party):
Wayne Ruppert, Bayfront Health St Petersburg
  Purpose
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.

Condition
Chest Pain Acute Coronary Syndrome Angina Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the Simple Acute Coronary Syndrome (SACS) Score and Head-to-Head Comparison of the SACS vs. Modified TIMI vs. HEART ACS Scores

Further study details as provided by Wayne Ruppert, Bayfront Health St Petersburg:

Primary Outcome Measures:
  • Angiographic Findings of Cardiac Catheterization [ Time Frame: 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:


Secondary Outcome Measures:
  • No CAD noted - no coronary interventions indicated [ Time Frame: 30 days from study enrollment ]
    Diagnostic coronary angiography reveals patient has no discernable coronary artery disease, no coronary artery interventions are indicated.

  • Mild-moderate CAD noted - no coronary artery interventions are indicated [ Time Frame: 30 days from study enrollment ]
    Diagnostic coronary angiography revealed one or more mild-moderate NON-Obstructive Lesion(s), no invasive intervention (PCI or CABG) indicated at current time.

  • Obstructive CAD present, no myocardial injury, immediate intervention is indicated [ Time Frame: 30 days from study enrollment ]
    Coronary angiography revealed significant Obstructive Lesion(s) present in one or more coronary artery. TIMI Grade III bloodflow is present, intervention (PCI or CABG revascularization) is indicated now.

  • Obstructive CAD present with myocardial infarction/ injury [ Time Frame: 30 days from study enrollment ]
    Coronary angiography revealed sub-total or total occlusion with <TIMI Grade III flow in one or more coronary artery, myocardial injury/infarction present, immediate intervention (PCI or CABG) indicated.

  • No Obstructive CAD present but myocardial damage is evident [ Time Frame: 30 days from study enrollment ]
    Coronary angiography reveals no obstructive CAD is present, but patient has sustained myocardial injury with decreased EF, consistent with vascular event such as vasospasm, Apical Balloon (Tako-Tsubo) Syndrome, Cocaine/Drug induced, or other myocardial injury.


Estimated Enrollment: 200
Study Start Date: February 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
STEMI / NSTEMI
All patients (100%) admitted to the participating hospitals during the study period with the diagnosis of Acute ST Segment Myocardial Infarction (STEMI) or Non-ST Segment Myocardial Infarction (NSTEMI) will be selected for inclusion in the study. In order to assure rapid door-to-reperfusion times, Study Investigators will obtain consent and interview these patients AFTER cardiac catheterization and intervention. A minimum number of 25 STEMI and 25 NSTEMI patients will be enrolled in the study.
Elective / Non-emergent Cardiac Cath
This group will include both admitted and outpatients, with possible diagnoses of Unstable Angina (UA), Low Risk Chest Pain (LRCP), and those having cardiac catheterization for any other reason (eg: elective, medical clearance for surgery, failed stress test, etc.). To maintain integrity of the study, these patients will be randomly selected, with written consent obtained, prior to cardiac catheterization.

Detailed Description:

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.

STUDY END POINT for all patients is CARDIAC CATHETERIZATION: The findings obtained during CORONARY ANGIOGRAPHY, and the need for immediate intervention, as dictated by the Interventional Cardiologist.

DATA TO BE COLLECTED: Patient symptoms, history, CAD risk factor profile, 12 Lead ECG findings, Lab results (Troponin, electrolytes, BUN/Creatinine, BNP), and all other data fields necessary to calculate a complete Modified TIMI, HEART and SACS score, Cardiac Cath Lab findings (description of coronary angiography for each vessel) and any Coronary Artery Interventions performed or recommended (PCI, CABG). . A STANDARDIZED DATA COLLECTION FORM has been developed and will be utilized for all patients.

REGRESSION ANALYSIS will result from 126 data points collected from each patient encounter. Relationships between score values and the degree of obstructive CAD present will be established, along with p values and sensitivity / specificity for each scoring system. Recommendations for modifications to currently existing scores, and/or proposals for development of a hybrid scoring system will result from the analysis of this data.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients selected in this study will be patients who are having URGENT (Group 1) or NON-URGENT (Group 2) cardiac catheterization performed:

Group 1: All (100%) of STEMI / Non-STEMI patients presenting for cardiac catheterization during the study period, with a minumum number of 25 STEMI and 25 NSTEMI patients to be included.

Group 2: Non-urgent cardiac catheterization patients will be randomly selected, with consents obtained, PRIOR TO elective cardiac catheterization.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  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): NCT02358148


Locations
United States, Florida
Bayfront Health Dade City
Dade City, Florida, United States, 33525
Bayfront Health St Petersburg
St Petersburg, Florida, United States, 33701
Sponsors and Collaborators
Bayfront Health St Petersburg
Bayfront Health Dade City
Community Health Systems (CHS)
Investigators
Principal Investigator: Wayne W Ruppert, CVT, CCCC Bayfront Health Dade City
Principal Investigator: Ravi Korabathina, MD, FSCAI Bayfront Health St Petersburg
  More Information

Additional Information:
Publications:
Responsible Party: Wayne Ruppert, Cardiac Data Specialist and Cardiovascular Clinical Coordinator, Bayfront Health St Petersburg
ClinicalTrials.gov Identifier: NCT02358148     History of Changes
Other Study ID Numbers: 521-0
First Submitted: February 3, 2015
First Posted: February 6, 2015
Last Update Posted: July 19, 2016
Last Verified: July 2016

Keywords provided by Wayne Ruppert, Bayfront Health St Petersburg:
Acute Coronary Syndrome
Chest Pain
ACS
Risk Stratification Score
HEART Score
Modified TIMI
Coronary Artery Disease
Risk Factors
Myocardial Infarction

Additional relevant MeSH terms:
Syndrome
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Chest Pain
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms