Better Evaluation of Acute Chest Pain With Computed Tomography Angiography (BEACON)
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Purpose
The purpose of this study is to determine whether cardiac CT can improve triage of acute chest pain patients in the emergency department.
| Condition | Intervention |
|---|---|
|
Acute Coronary Syndrome Acute Chest Pain |
Radiation: Cardiac CT |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 500 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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:
- 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
Contacts and Locations| Contact: Admir Dedic, MD | 0031107030420 | a.dedic@erasmusmc.nl |
| Contact: Koen Nieman, MD, PhD | 0031633334340 | k.nieman@erasmusmc.nl |
| Netherlands | |
| Erasmus MC | Recruiting |
| Rotterdam, Netherlands | |
| Contact: Admir Dedic, MD 0031107030420 a.dedic@erasmusmc.nl | |
| Contact: Koen Nieman, MD, PhD 0031633334340 k.nieman@erasmusmc.nl | |
| Sub-Investigator: Admir Dedic, MD | |
| Principal Investigator: Koen Nieman, MD, PhD | |
More Information
No publications provided
| Responsible Party: | dr. K. Nieman, Erasmus MC |
| ClinicalTrials.gov Identifier: | NCT01413282 History of Changes |
| Other Study ID Numbers: | BEACON-11 |
| Study First Received: | August 9, 2011 |
| Last Updated: | August 9, 2011 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Erasmus Medical Center:
|
Acute coronary syndrome |
Additional relevant MeSH terms:
|
Chest Pain Acute Coronary Syndrome Pain Signs and Symptoms Myocardial Ischemia |
Heart Diseases Cardiovascular Diseases Angina Pectoris Vascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013