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

Primary Purpose

Acute Coronary Syndrome, Acute Chest Pain

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Cardiac CT
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring Acute coronary syndrome

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erasmus MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Cardiac CT

Standard Care

Arm Description

Triage based on cardiac CT results.

Standard diagnostic management according to the European guidelines.

Outcomes

Primary Outcome Measures

Successful discharge rate
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
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
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
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
Diagnosis of acute coronary syndrome, according to international guidelines, at time of discharge.
Missed myocardial infarctions
Missed myocardial infarctions, at 2-day follow-up, in patients discharged from the emergency department.
Duration of hospital stay
Duration of hospital stay
Direct medical cost
Direct medical costs until 30th day after ED visit.
Radiation exposure
Cumulative medical radiation exposure at 6 months.
Renal function
Change in renal function after 2 days.

Full Information

First Posted
August 9, 2011
Last Updated
August 3, 2016
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01413282
Brief Title
Better Evaluation of Acute Chest Pain With Computed Tomography Angiography
Acronym
BEACON
Official Title
Better Evaluation of Acute Chest Pain With Computed Tomography Angiography - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Acute Chest Pain
Keywords
Acute coronary syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac CT
Arm Type
Active Comparator
Arm Description
Triage based on cardiac CT results.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Standard diagnostic management according to the European guidelines.
Intervention Type
Radiation
Intervention Name(s)
Cardiac CT
Intervention Description
Calcium scan and CT coronary angiography
Primary Outcome Measure Information:
Title
Successful discharge rate
Description
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.
Time Frame
30 days
Title
Diagnostic yield of invasive angiography
Description
Number of patients identified with severe coronary artery disease identified by invasive angiography requiring revascularisation according to the international guidelines.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Successful discharge rate for all adverse events
Description
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.
Time Frame
30 days
Title
Major adverse events
Description
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.
Time Frame
6 months
Title
Acute coronary syndrome
Description
Diagnosis of acute coronary syndrome, according to international guidelines, at time of discharge.
Time Frame
Index hospital visit
Title
Missed myocardial infarctions
Description
Missed myocardial infarctions, at 2-day follow-up, in patients discharged from the emergency department.
Time Frame
2 days
Title
Duration of hospital stay
Description
Duration of hospital stay
Time Frame
Index hospital visit
Title
Direct medical cost
Description
Direct medical costs until 30th day after ED visit.
Time Frame
30 days
Title
Radiation exposure
Description
Cumulative medical radiation exposure at 6 months.
Time Frame
6 months
Title
Renal function
Description
Change in renal function after 2 days.
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koen Nieman, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26764061
Citation
Dedic A, Lubbers MM, Schaap J, Lammers J, Lamfers EJ, Rensing BJ, Braam RL, Nathoe HM, Post JC, Nielen T, Beelen D, le Cocq d'Armandville MC, Rood PP, Schultz CJ, Moelker A, Ouhlous M, Boersma E, Nieman K. Coronary CT Angiography for Suspected ACS in the Era of High-Sensitivity Troponins: Randomized Multicenter Study. J Am Coll Cardiol. 2016 Jan 5;67(1):16-26. doi: 10.1016/j.jacc.2015.10.045.
Results Reference
derived

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Better Evaluation of Acute Chest Pain With Computed Tomography Angiography

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