Better Evaluation of Acute Chest Pain With Computed Tomography Angiography

Acute Coronary Syndrome Clinical Trial

— BEACON  

Official title:

Better Evaluation of Acute Chest Pain With Computed Tomography Angiography - A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01413282
• Other study ID #: BEACON-11
• Status: Completed
• Phase: N/A
• First received: August 9, 2011
• Last updated: August 3, 2016
• Start date: July 2011
• Est. completion date: February 2015

Study information

• Verified date: August 2016
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Chest Pain
• Acute Coronary Syndrome
• Chest Pain

Intervention

Radiation:
• Cardiac CT
Calcium scan and CT coronary angiography

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	Acute coronary syndrome	Diagnosis of acute coronary syndrome, according to international guidelines, at time of discharge.	Index hospital visit	No
Secondary	Missed myocardial infarctions	Missed myocardial infarctions, at 2-day follow-up, in patients discharged from the emergency department.	2 days	Yes
Secondary	Duration of hospital stay	Duration of hospital stay	Index hospital visit	No
Secondary	Direct medical cost	Direct medical costs until 30th day after ED visit.	30 days	No
Secondary	Radiation exposure	Cumulative medical radiation exposure at 6 months.	6 months	Yes
Secondary	Renal function	Change in renal function after 2 days.	2 days	Yes