Clinical trial NCT01413282: Better Evaluation of Acute Chest Pain With Computed Tomography Angiography
Official title: Better Evaluation of Acute Chest Pain With Computed Tomography Angiography - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Acute Chest Pain
Keywords: Acute coronary syndrome
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2011-08-10
Enrollment: 500
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful discharge rate
timeFrame: 30 days
measure: Diagnostic yield of invasive angiography
timeFrame: 30 days
Secondary outcomes:
measure: Successful discharge rate for all adverse events
timeFrame: 30 days
measure: Major adverse events
timeFrame: 6 months
measure: Acute coronary syndrome
timeFrame: Index hospital visit
measure: Missed myocardial infarctions
timeFrame: 2 days
measure: Duration of hospital stay
timeFrame: Index hospital visit
measure: Direct medical cost
timeFrame: 30 days
measure: Radiation exposure
timeFrame: 6 months
measure: Renal function
timeFrame: 2 days
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: Koen Nieman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.