"SVEAT" Chest Pain Scoring System

Sponsor
University of Nevada, Reno (Other)
Overall Status
Completed
CT.gov ID
NCT03511430
Collaborator
Renown Regional Medical Center (Other)
370
1
17.3
21.4

Study Details

Study Description

Brief Summary

This is a prospective, observational study to assess the efficacy of the newly developed SVEAT scoring system in identifying low-risk patients who may be eligible for early discharge. Various elements of clinical information including Symptoms, Vascular history, EKG, Age and Troponin values will be checked and entered on the scoring form to calculate the SVEAT risk score. Additionally, HEART score and TIMI risk score will be calculated for the same subjects.

The primary aim is to assess the positive and negative predictive values for the SVEAT index for cardiovascular events and compare it to the HEART and TIMI Scores.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a prospective, observational study in patients presenting to the emergency department or admitted to clinical decision unit at Renown Regional Medical Center with a primary complaint of chest pain in a period of 12 months.

    All patient >24 years will be recruited. Exclusion criteria include patients with clear-cut acute ST-segment elevation myocardial infarction, traumatic non-cardiac chest pain, life-expectancy less than 90 days, hemodynamic instability or inability to provide informed consent. Data and scores based on commonly known TIMI* risk score, HEART score and a newly developed SVEAT index ( Symptoms, Vascular disease, EKG, Age, Troponin) will be obtained by primary investigator trained physicians or advanced nurse practitioners as earliest as possible after their initial presentation. The care of the patients will be left to the discretion of the treating physician.

    The outcome of each patient will be determined by either chart review, telephone contact or office visit as appropriate in 30 days post presentation. The sensitivity, specificity, positive and negative predictive value of SVEAT index will be calculated using standard statistical analysis. The receiver operating characteristic (ROC) curves of SVEAT index, TIMI risk score and HEART score will be generated and compared using commercially available software. P value of 0.05 or less will be considered statistically significant difference.

    The primary hypothesis of the study is that scoring systems that better incorporate useful clinical information such as the SVEAT score may improve our ability to accurately identify low-risk acute chest pain patients presenting to the ED.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    370 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Performance of a New Risk Score (SVEAT Index) to Identify Low-risk Patients Presenting to Emergency Department With Acute Chest Pain
    Actual Study Start Date :
    May 1, 2017
    Actual Primary Completion Date :
    Sep 15, 2018
    Actual Study Completion Date :
    Oct 10, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Occurence of MACE (Major Adverse Cardiac Events) [30 days]

      The number of subjects diagnosed with MACE (Acute Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting, Significant stenosis with conservative therapy, Death)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    24 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Any patient > 24 years old presenting to the emergency room or admitted to the clinical decision unit with chest pain.
    Exclusion Criteria:
    • patient with clear-cut acute ST-segment elevation myocardial infarction, traumatic non-cardiac chest pain, life-expectancy less than 90 days, hemodynamic instability or inability to provide informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Renown Regional Medical Center Reno Nevada United States 89502

    Sponsors and Collaborators

    • University of Nevada, Reno
    • Renown Regional Medical Center

    Investigators

    • Principal Investigator: Chanwit Roongsritong, MD, FACC, University of Nevada, Reno

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chanwit Roongsritong, MD. FACC., University of Nevada, Reno
    ClinicalTrials.gov Identifier:
    NCT03511430
    Other Study ID Numbers:
    • 986654
    First Posted:
    Apr 27, 2018
    Last Update Posted:
    Oct 11, 2018
    Last Verified:
    Oct 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chanwit Roongsritong, MD. FACC., University of Nevada, Reno
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 11, 2018