NCT00243516

Brief Summary

The purpose of this study is to evaluate if the implementation of quantitative pretest probability assessment will significantly reduce the unnecessary use of the intra-emergency department chest pain center. Specifically, the study will examine whether the PREtest Consult acute coronary syndrome (ACS) pretest probability assessment system can significantly reduce the use of chest pain unit evaluation in very low risk emergency department (ED) patients, can safely discharge patients with a pretest probability ≤ 2.0%, can reduce unnecessary procedures and lower hospital costs and will examine patient satisfaction of patients with whom pretest probability assessment was used compared to those with whom it was not used. The researchers hypothesize that patients in the control group of the study will have statistically significant reductions in mean time spent in the emergency department, mean charges billed to the patient or their insurance carrier, hospital length of stay, mean number of procedures or tests performed without a statistically significant change in patient satisfaction or adverse outcome.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 24, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

November 9, 2007

Status Verified

September 1, 2006

First QC Date

October 17, 2005

Last Update Submit

November 8, 2007

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary SyndromeEmergency DepartmentChest Pain Evaluation UnitOvertestingChest Pain ProtocolMyocardial InfarctionMedical Malpractice

Outcome Measures

Primary Outcomes (4)

  • Documented myocardial infarction (ESC criteria)

  • Death thought to be from ACS (autopsy not required)

  • Need for revascularization (stent or surgical) within 45 days

  • Cardiac catheterization demonstrating

Secondary Outcomes (7)

  • Percentage of patients deemed very low risk (pretest probability less than 2%) by the physician or the PREtest Consult ACS platform during the index visit

  • Percentage of patients discharged without admission to the hospital or emergency department chest pain unit during the index visit

  • Length of stay for the index visit to the emergency department

  • Incidence of stress testing, cardiac imaging and cardiac catheterization during the index visit and in the 45 days following the index visit

  • Hospital charges billed to each patient or their insurance provider for the index visit

  • +2 more secondary outcomes

Interventions

PREtest ConsultDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Emergency department patients aged \> 17 who report a history of torso or arm discomfort within the past 24 hours.
  • Physician orders an electrocardiogram and serum troponin measurement.
  • Physician has undergone a 10 minute explanation session and has provided consent

You may not qualify if:

  • lead electrocardiogram (ECG) with ST deviation or T-wave changes that are interpreted by clinician as indicative of acute infarction or ischemia
  • "Code STEMI" patients (patients with suspected acute myocardial infarction).
  • Other primary diagnosis mandating admission (e.g., pneumonia, diabetic ketoacidosis, trauma)
  • Patients with myocardial infarction, intracoronary stent placement, or coronary artery bypass grafting within the previous 30 days.
  • Evidence of circulatory shock (SBP \[systolic blood pressure\] \< 100 mmHg with symptoms defined by Jones)
  • Cocaine use within the past 72 hours.
  • A moderate to high-risk composite clinical picture that causes an emergency medicine specialist to consult a cardiologist.
  • Homelessness, out-of-town residence or other condition known to preclude follow-up.
  • Prisoners and pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

RECRUITING

MeSH Terms

Conditions

Acute Coronary SyndromeEmergenciesMyocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsInfarctionIschemiaNecrosis

Study Officials

  • Jeffrey A Kline, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

William B Webb, BSPH

CONTACT

704-355-0602bwebb@pretestconsult.com

Jane A Kilkenny, BA

CONTACT

704-355-3975jane.kilkenny@carolinashealthcare.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 17, 2005

First Posted

October 24, 2005

Study Start

October 1, 2005

Study Completion

October 1, 2007

Last Updated

November 9, 2007

Record last verified: 2006-09

Locations

US(1)