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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome; Acute Chest Pain
• Intervention / Treatment: Radiation: Cardiac CT

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Erasmus MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days
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.	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Koen Nieman, MD, PhD, Erasmus MC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: August 9, 2011
• First Submitted That Met QC Criteria: August 9, 2011
• First Posted (Estimate): August 10, 2011

Study Record Updates

• Last Update Posted (Estimate): August 4, 2016
• Last Update Submitted That Met QC Criteria: August 3, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Acute coronary syndrome
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Acute Coronary Syndrome
• Other Study ID Numbers: BEACON-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No