- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01413282
Better Evaluation of Acute Chest Pain With Computed Tomography Angiography (BEACON)
Better Evaluation of Acute Chest Pain With Computed Tomography Angiography - A Randomized Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Rotterdam, Holland
- Erasmus MC
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Cardiac CT
Triage based on cardiac CT results.
|
Calcium scan and CT coronary angiography
|
Ingen indgriben: Standard Care
Standard diagnostic management according to the European guidelines.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Successful discharge rate
Tidsramme: 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.
|
30 days
|
Diagnostic yield of invasive angiography
Tidsramme: 30 days
|
Number of patients identified with severe coronary artery disease identified by invasive angiography requiring revascularisation according to the international guidelines.
|
30 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Successful discharge rate for all adverse events
Tidsramme: 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.
|
30 days
|
Major adverse events
Tidsramme: 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.
|
6 months
|
Acute coronary syndrome
Tidsramme: Index hospital visit
|
Diagnosis of acute coronary syndrome, according to international guidelines, at time of discharge.
|
Index hospital visit
|
Missed myocardial infarctions
Tidsramme: 2 days
|
Missed myocardial infarctions, at 2-day follow-up, in patients discharged from the emergency department.
|
2 days
|
Duration of hospital stay
Tidsramme: Index hospital visit
|
Duration of hospital stay
|
Index hospital visit
|
Direct medical cost
Tidsramme: 30 days
|
Direct medical costs until 30th day after ED visit.
|
30 days
|
Radiation exposure
Tidsramme: 6 months
|
Cumulative medical radiation exposure at 6 months.
|
6 months
|
Renal function
Tidsramme: 2 days
|
Change in renal function after 2 days.
|
2 days
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Koen Nieman, MD, PhD, Erasmus MC
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BEACON-11
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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