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Better Evaluation of Acute Chest Pain With Computed Tomography Angiography

Not Applicable
Completed
Conditions
Acute Coronary Syndrome
Acute Chest Pain
Interventions
Radiation: Cardiac CT
Registration Number
NCT01413282
Lead Sponsor
Erasmus Medical Center
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
500
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Cardiac CTCardiac CTTriage based on cardiac CT results.
Primary Outcome Measures
NameTimeMethod
Successful discharge rate30 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 angiography30 days

Number of patients identified with severe coronary artery disease identified by invasive angiography requiring revascularisation according to the international guidelines.

Secondary Outcome Measures
NameTimeMethod
Successful discharge rate for all adverse events30 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.

Major adverse events6 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.

Duration of hospital stayIndex hospital visit

Duration of hospital stay

Direct medical cost30 days

Direct medical costs until 30th day after ED visit.

Missed myocardial infarctions2 days

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

Radiation exposure6 months

Cumulative medical radiation exposure at 6 months.

Acute coronary syndromeIndex hospital visit

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

Renal function2 days

Change in renal function after 2 days.

Trial Locations

Locations (1)

Erasmus MC

🇳🇱

Rotterdam, Netherlands

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