"SVEAT" Chest Pain Scoring System

Chest Pain Clinical Trial

Official title:

Performance of a New Risk Score (SVEAT Index) to Identify Low-risk Patients Presenting to Emergency Department With Acute Chest Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03511430
• Other study ID #: 986654
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: October 10, 2018

Study information

• Verified date: October 2018
• Source: University of Nevada, Reno
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: October 10, 2018
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chest Pain

Locations

Country	Name	City	State
United States	Renown Regional Medical Center	Reno	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
University of Nevada, Reno	Renown Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of MACE (Major Adverse Cardiac Events)	The number of subjects diagnosed with MACE (Acute Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting, Significant stenosis with conservative therapy, Death)	30 days