Better Evaluation of Acute Chest Pain With Computed Tomography Angiography (BEACON)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Koen Nieman, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01413282
First received: August 9, 2011
Last updated: February 20, 2014
Last verified: February 2014

August 9, 2011
February 20, 2014
July 2011
February 2014   (final data collection date for primary outcome measure)
  • Successful discharge rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of patients identified with severe coronary artery disease identified by invasive angiography requiring revascularisation according to the international guidelines.
Same as current
Complete list of historical versions of study NCT01413282 on ClinicalTrials.gov Archive Site
  • Successful discharge rate for all adverse events [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    The proportion of patients discharged home without any adverse events during the following 30 days. Adverse events are cardiovascular death, non-fatal myocardial infarction, unstable angina, coronary revascularization, repeat hospital visits for chest pain.
  • Major adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Composite endpoint of major adverse cardiac events at 6 months: cardiovascular death, non-fatal myocardial infarction, unstable angina, coronary revascularisation and repeat hospital visits for chest pain.
  • Acute coronary syndrome [ Time Frame: Index hospital visit ] [ Designated as safety issue: No ]
    Diagnosis of acute coronary syndrome, according to international guidelines, at time of discharge.
  • Missed myocardial infarctions [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Missed myocardial infarctions, at 2-day follow-up, in patients discharged from the emergency department.
  • Duration of hospital stay [ Time Frame: Index hospital visit ] [ Designated as safety issue: No ]
    Duration of hospital stay
  • Direct medical cost [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Direct medical costs until 30th day after ED visit.
  • Radiation exposure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Cumulative medical radiation exposure at 6 months.
  • Renal function [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Change in renal function after 2 days.
Same as current
Not Provided
Not Provided
 
Better Evaluation of Acute Chest Pain With Computed Tomography Angiography
Better Evaluation of Acute Chest Pain With Computed Tomography Angiography - A Randomized Controlled Trial

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Acute Coronary Syndrome
  • Acute Chest Pain
Radiation: Cardiac CT
Calcium scan and CT coronary angiography
  • Active Comparator: Cardiac CT
    Triage based on cardiac CT results.
    Intervention: Radiation: Cardiac CT
  • No Intervention: Standard Care
    Standard diagnostic management according to the European guidelines.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
August 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • STEMI
  • Troponin > 0.1
  • History of known myocardial infarction, PCI or CABG
  • Pregnancy
  • Contrast allergy
  • Renal disfunction
  • No informed consent possible
  • No follow-up possible
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01413282
BEACON-11
Yes
Koen Nieman, Erasmus Medical Center
Erasmus Medical Center
Not Provided
Not Provided
Erasmus Medical Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP