Recruiting
Phase 3

Observational Study

Sponsor:

PREtest Consult

Code:

NCT00243516

Conditions

Acute Coronary Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PREtest Consult

Study Details

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.

Conditions

Acute Coronary Syndrome

Study ID

NCT00243516

Start date

Oct, 2005

Status verified date

Sep, 2006

Completion date

Oct, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 12-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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Interventions

PREtest Consult

Primary outcome measure

  • Documented myocardial infarction (ESC criteria) [ Time Frame: undefined ]
  • Death thought to be from ACS (autopsy not required) [ Time Frame: undefined ]
  • Need for revascularization (stent or surgical) within 45 days [ Time Frame: undefined ]
  • Cardiac catheterization demonstrating [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Principal Investigator:

Jeffrey A Kline, MD

More Information

Sponsor

PREtest Consult

Last update posted

Nov 9, 2007

Last verified

Sep, 2006

Keywords

  • Acute Coronary Syndrome
  • Emergency Department
  • Chest Pain Evaluation Unit
  • Overtesting
  • Chest Pain Protocol
  • Myocardial Infarction
  • Medical Malpractice

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by PREtest Consult on 2007-11-09.