Better Evaluation of Acute Chest Pain With Computed Tomography * a Randomized Prospective Trial

Better Evaluation of Acute Chest Pain With Computed Tomography * a Randomized Prospective Trial - BEACON trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39354

Enrollment

500

Registered

2011-05-10

Start date

2011-06-17

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease

Interventions

Diagnostic intervention with replacement of the standard optimal care (based upon serial blood testing and stresst testing) by a strategy based upon cardiac CT-scan.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Acute chest pain or equivalent possibly caused by coronary artery disease. Age >30 years, ability and willingness to provide informed consent.

Exclusion criteria

Exclusion criteria: History of significant CAD, defined as prior myocardial infarction, percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery. Very low likelihood of an ACS, based on demographics, risk factors and presentation (normal ECG and initial markers), without clinical requirement for observation or further investigation. Very high-risk ACS with need for immediate coronary angiography ( 0.1, high risk patients who will require early invasive angiography (

Design outcomes

Primary

Measure	Time frame
1) The proportion of patients discharged from the ED without adverse events in the following 30 days. Adverse events are defined as death, non-fatal myocardial infarction or coronary revascularisation. 2) The diagnostic yield is defined as the number of patients with severe coronary artery disease (by invasive angiography). Severe coronary artery disease is defined as a flow limiting or highly vulnerable plaque in one or more vessels, requiring revascularization according to established guidelines.	—

Measure

Time frame

1) The proportion of patients discharged from the ED without adverse events in the following 30 days. Adverse events are defined as death, non-fatal myocardial infarction or coronary revascularisation. 2) The diagnostic yield is defined as the number of patients with severe coronary artery disease (by invasive angiography). Severe coronary artery disease is defined as a flow limiting or highly vulnerable plaque in one or more vessels, requiring revascularization according to established guidelines.

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Secondary

Measure	Time frame
a) Successful discharge rate for all adverse events (at 30 days): death, non-fatal MI, unstable angina, coronary revascularization, and repeat hospital visits for chest pain. b) Composite endpoint of major adverse cardiac events at 6 months: cardiac death, non-fatal myocardial infarction, unstable angina and repeats hospital visits for chest pain. c) Diagnosis of acute coronary syndrome (cardiovascular death, myocardial infarction, instable angina according to the European guidelines of cardiology16) at time of discharge. d) Late myocardial ischemia (at 2-day follow-up). e) Duration of hospital stay. f) Direct medical costs until 30th day after ED visit. g) Radiation exposure	—

Measure

Time frame

a) Successful discharge rate for all adverse events (at 30 days): death, non-fatal MI, unstable angina, coronary revascularization, and repeat hospital visits for chest pain. b) Composite endpoint of major adverse cardiac events at 6 months: cardiac death, non-fatal myocardial infarction, unstable angina and repeats hospital visits for chest pain. c) Diagnosis of acute coronary syndrome (cardiovascular death, myocardial infarction, instable angina according to the European guidelines of cardiology16) at time of discharge. d) Late myocardial ischemia (at 2-day follow-up). e) Duration of hospital stay. f) Direct medical costs until 30th day after ED visit. g) Radiation exposure

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)