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Completed

NCT Number: NCT01413282

Better Evaluation of Acute Chest Pain With Computed Tomography Angiography

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

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Key information

Conditions

Acute Coronary Syndrome Acute Chest Pain Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus MC

Rotterdam, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac CT

Radiation

Calcium scan and CT coronary angiography

Primary outcomes

  1. Successful discharge rate

    Time frame: 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

    Time frame: 30 days

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

Secondary outcomes

  1. Successful discharge rate for all adverse events

    Time frame: 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

    Time frame: 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

    Time frame: Index hospital visit

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

  4. Missed myocardial infarctions

    Time frame: 2 days

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

  5. Duration of hospital stay

    Time frame: Index hospital visit

    Duration of hospital stay

  6. Direct medical cost

    Time frame: 30 days

    Direct medical costs until 30th day after ED visit.

  7. Radiation exposure

    Time frame: 6 months

    Cumulative medical radiation exposure at 6 months.

  8. Renal function

    Time frame: 2 days

    Change in renal function after 2 days.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

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

Acronym: BEACON

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Aug 10, 2011
Registry last updated
Aug 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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