"SVEAT" Chest Pain Scoring System

Completed

• Conditions: Chest Pain

• Registration Number: NCT03511430
• Lead Sponsor: University of Nevada, Reno

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.

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 Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-04-17
• Study First Posted: 2018-04-27
• Primary Completion: 2018-09-15
• Status Verified: 2018-10
• Study Completion: 2018-10-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Renown Regional Medical Center; 🇺🇸 Reno, Nevada, United States