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Clinical Trials/NCT01413282
NCT01413282
Completed
Not Applicable

Better Evaluation of Acute Chest Pain With Computed Tomography Angiography - A Randomized Controlled Trial

Erasmus Medical Center1 site in 1 country500 target enrollmentJuly 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Coronary Syndrome
Sponsor
Erasmus Medical Center
Enrollment
500
Locations
1
Primary Endpoint
Successful discharge rate
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is to determine whether cardiac CT can improve triage of acute chest pain patients in the emergency department.

Detailed Description

Myocardial infarction remains one of the most important causes of death and disability. Therefore it is important that individuals with acute chest pain are accurately assessed without delaying appropriate treatment. Acute coronary syndrome is only one cause for sudden chest pain, which is a very common complaint in the ER. Other life threatening causes such as pulmonary embolism and aortic dissection may also be the cause, although most chest discomfort has a benign reason (musculoskeletal, hyperventilation, oesophageal reflux, etc). The current work-up of suspected acute coronary syndrome, based on presentation, symptoms, ECG and biomarkers, is not efficient and results in unnecessary diagnostics and hospital admissions, as well as errors or delayed diagnoses, in a substantial number of patients. Computed tomography angiography (CTA) images atherosclerosis, coronary obstruction as well as myocardial hypoperfusion. We hypothesize that early use of CTA is of incremental value and allows for accurate and immediate triage of patients with acute chest pain.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
February 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Koen Nieman

Associate professor

Erasmus Medical Center

Eligibility Criteria

Inclusion Criteria

  • Acute chest pain or equivalent
  • Patients older than 30 years
  • Males \< 75 years and Females \< 80 years

Exclusion Criteria

  • Troponin \> 0.1
  • History of known myocardial infarction, PCI or CABG
  • Pregnancy
  • Contrast allergy
  • Renal disfunction
  • No informed consent possible
  • No follow-up possible

Outcomes

Primary Outcomes

Successful discharge rate

Time Frame: 30 days

The proportion of patients discharged home without major adverse events during the following 30 days. Major adverse events are cardiovascular death or non-fatal myocardial infarction.

Diagnostic yield of invasive angiography

Time Frame: 30 days

Number of patients identified with severe coronary artery disease identified by invasive angiography requiring revascularisation according to the international guidelines.

Secondary Outcomes

  • Successful discharge rate for all adverse events(30 days)
  • Major adverse events(6 months)
  • Duration of hospital stay(Index hospital visit)
  • Direct medical cost(30 days)
  • Missed myocardial infarctions(2 days)
  • Radiation exposure(6 months)
  • Acute coronary syndrome(Index hospital visit)
  • Renal function(2 days)

Study Sites (1)

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