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CompletedNCT01413282BEACONUpdated Aug 4, 2016

Better Evaluation of Acute Chest Pain With Computed Tomography Angiography

An interventional study of Cardiac CT in Acute Coronary Syndrome and Acute Chest Pain, sponsored by Erasmus Medical Center. Completed at 1 site in Netherlands. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-08-04.

Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Acute Coronary Syndrome
  • Acute Chest Pain

Keywords

  • Acute coronary syndrome
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In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 500 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (actual)

Study arms

  • Active comparator
    Cardiac CT

    Triage based on cardiac CT results.

    Radiation: Cardiac CT

  • No intervention
    Standard Care

    Standard diagnostic management according to the European guidelines.

Interventions

  • RadiationCardiac CT

    Calcium scan and CT coronary angiography

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days

  2. 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.

    Time frame: 30 days

Secondary outcomes

  1. 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.

    Time frame: 30 days

  2. 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.

    Time frame: 6 months

  3. Acute coronary syndrome

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

    Time frame: Index hospital visit

  4. Missed myocardial infarctions

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

    Time frame: 2 days

  5. Duration of hospital stay

    Duration of hospital stay

    Time frame: Index hospital visit

  6. Direct medical cost

    Direct medical costs until 30th day after ED visit.

    Time frame: 30 days

  7. Radiation exposure

    Cumulative medical radiation exposure at 6 months.

    Time frame: 6 months

  8. Renal function

    Change in renal function after 2 days.

    Time frame: 2 days

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Study locations

1 site
  • Erasmus MC
    Rotterdam, Netherlands
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References and documents

Publications

  • Dedic A, Lubbers MM, Schaap J, Lammers J, Lamfers EJ, Rensing BJ, Braam RL, Nathoe HM, Post JC, Nielen T, Beelen D, le Cocq d'Armandville MC, Rood PP, Schultz CJ, Moelker A, Ouhlous M, Boersma E, Nieman K. Coronary CT Angiography for Suspected ACS in the Era of High-Sensitivity Troponins: Randomized Multicenter Study. J Am Coll Cardiol. 2016 Jan 5;67(1):16-26. doi: 10.1016/j.jacc.2015.10.045. PubMed 26764061 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01413282
Lead sponsor
Erasmus Medical Center
Responsible party
Koen Nieman (Associate professor, Erasmus Medical Center) — Principal investigator
First posted
Aug 10, 2011
Start date
Jul 2011
Primary completion
Feb 2014
Completion
Feb 2015
Last update
Aug 4, 2016

Study contacts

Koen Nieman, MD, PhD
principal investigator · Erasmus Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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