Better Evaluation of Acute Chest Pain With Computed Tomography Angiography (BEACON)
|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|
- 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.
- 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.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||August 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413282