Acute Coronary SyndromeBEACONNCT01413282
Better Evaluation of Acute Chest Pain With Computed Tomography Angiography
A study testing Cardiac CT in people with Acute Coronary Syndrome and Acute Chest Pain, run by Erasmus Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome, Acute Chest Pain
- What is being tested?
- Cardiac CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2011to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute chest pain or equivalent
- Patients older than 30 years
- Males < 75 years and Females < 80 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Better Evaluation of Acute Chest Pain With Computed Tomography Angiography - A Randomized Controlled Trial
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.
- Conditions
- Acute Coronary Syndrome, Acute Chest Pain
- Being tested
- Cardiac CT
- Keywords
- Acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CTRadiation
Calcium scan and CT coronary angiography
| Study group | Role | What they receive |
|---|---|---|
| Cardiac CT | Active comparator | Triage based on cardiac CT results. Receives: Radiation: Cardiac CT |
| Standard Care | No intervention | Standard diagnostic management according to the European guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
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.
Measured: 30 days
Secondary outcomes (8)
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.
Measured: 30 days
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.
Measured: 6 months
Acute coronary syndrome
Diagnosis of acute coronary syndrome, according to international guidelines, at time of discharge.
Measured: Index hospital visit
Missed myocardial infarctions
Missed myocardial infarctions, at 2-day follow-up, in patients discharged from the emergency department.
Measured: 2 days
Duration of hospital stay
Duration of hospital stay
Measured: Index hospital visit
Direct medical cost
Direct medical costs until 30th day after ED visit.
Measured: 30 days
Radiation exposure
Cumulative medical radiation exposure at 6 months.
Measured: 6 months
Renal function
Change in renal function after 2 days.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koen Nieman, Erasmus Medical Center
- Investigators
- Koen Nieman, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413282
- Sponsor's protocol ID
- BEACON-11
- Acronym
- BEACON
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2011
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Evaluation of Acute Chest Pain With Computed Tomography Angiography - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01413282
- Acronym / sponsor ID
- BEACON / BEACON-11
- Conditions
- Acute Coronary Syndrome, Acute Chest Pain
- Keywords
- Acute coronary syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether cardiac CT can improve triage of acute chest pain patients in the emergency department.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac CT | Active comparator | Radiation: Cardiac CTTriage based on cardiac CT results. |
| Standard Care | No intervention | –Standard diagnostic management according to the European guidelines. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute chest pain or equivalent
- Patients older than 30 years
- Males < 75 years and Females < 80 years
Key exclusion criteria (8 listed)
- STEMI
- Troponin > 0.1
- History of known myocardial infarction, PCI or CABG
- Pregnancy
- Contrast allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac CTCalcium scan and CT coronary angiography | Radiation | Cardiac CT |
Primary outcome
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.
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.
8 secondary outcomes
Successful discharge rate for all adverse events
Time frame: 30 days
Major adverse events
Time frame: 6 months
Acute coronary syndrome
Time frame: Index hospital visit
Missed myocardial infarctions
Time frame: 2 days
Duration of hospital stay
Time frame: Index hospital visit
Direct medical cost
Time frame: 30 days
Radiation exposure
Time frame: 6 months
Renal function
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Derived from this study: PubMed 26764061Dedic 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.
- Individual participant dataSharing planned: No
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koen Nieman, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac CT in people with Acute Coronary Syndrome and Acute Chest Pain, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful discharge rate (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01413282, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.