BEACON: Better Evaluation of Acute Chest Pain With Computed Tomography Angiography

• Sponsor: Erasmus Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01413282
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Arms: 2
• Duration (Months): 43.1
• Patients Per Site Per Month: 11.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome; Acute Chest Pain	Radiation: Cardiac CT	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Better Evaluation of Acute Chest Pain With Computed Tomography Angiography - A Randomized Controlled Trial
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Successful discharge rate [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.

2. Diagnostic yield of invasive angiography [30 days]

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

Secondary Outcome Measures

1. Successful discharge rate for all adverse events [30 days]

   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.

2. Major adverse events [6 months]

   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.

3. Acute coronary syndrome [Index hospital visit]

   Diagnosis of acute coronary syndrome, according to international guidelines, at time of discharge.

4. Missed myocardial infarctions [2 days]

   Missed myocardial infarctions, at 2-day follow-up, in patients discharged from the emergency department.

5. Duration of hospital stay [Index hospital visit]

   Duration of hospital stay

6. Direct medical cost [30 days]

   Direct medical costs until 30th day after ED visit.

7. Radiation exposure [6 months]

   Cumulative medical radiation exposure at 6 months.

8. Renal function [2 days]

   Change in renal function after 2 days.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Erasmus MC	Rotterdam		Netherlands

Sponsors and Collaborators

• Erasmus Medical Center

Investigators

• Principal Investigator: Koen Nieman, MD, PhD, Erasmus MC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Koen Nieman, Associate professor, Erasmus Medical Center
• ClinicalTrials.gov Identifier: NCT01413282
• Other Study ID Numbers: BEACON-11
• First Posted: Aug 10, 2011
• Last Update Posted: Aug 4, 2016
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Koen Nieman, Associate professor, Erasmus Medical Center: Acute coronary syndrome
• Additional relevant MeSH terms: Acute Coronary Syndrome; Chest Pain

Study Results

No Results Posted as of Aug 4, 2016