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
  Purpose

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


Condition Intervention
Acute Coronary Syndrome
Acute Chest Pain
Radiation: Cardiac CT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Better Evaluation of Acute Chest Pain With Computed Tomography Angiography - A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 500
Study Start Date: July 2011
Estimated Study Completion Date: August 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cardiac CT
Triage based on cardiac CT results.
Radiation: Cardiac CT
Calcium scan and CT coronary angiography
No Intervention: Standard Care
Standard diagnostic management according to the European guidelines.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01413282

Locations
Netherlands
Erasmus MC
Rotterdam, Netherlands
Sponsors and Collaborators
Erasmus Medical Center
  More Information

No publications provided

Responsible Party: Koen Nieman, Associate professor, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01413282     History of Changes
Other Study ID Numbers: BEACON-11
Study First Received: August 9, 2011
Last Updated: February 20, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
Acute coronary syndrome

Additional relevant MeSH terms:
Chest Pain
Acute Coronary Syndrome
Pain
Signs and Symptoms
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases

ClinicalTrials.gov processed this record on September 11, 2014