Diagnostic Performance and Cost of Cardiac Computed Tomographic Angiography versus Stress Electrocardiography – a Randomized Prospective Study of Suspected Acute Coronary Syndrome Chest Pain in the Emergency Department

A single centre, randomised, unblinded, prospective trial on the diagnostic performance and cost of coronary computed tomographic angiography compared to exercise stress angiography in patients presenting to the emergency department with chest pain suspected of acute coronary syndrome.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000630617

Acronym

CT-COMPARE

Enrollment

592

Registered

2014-06-13

Start date

2010-01-11

Completion date

2011-04-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Chest pain is a common cause for presentations to hospital Emergency Departments (ED). The clinical investigation of undifferentiated chest pain must include the expeditious assessment for acute coronary syndrome. To date, there have been no large-scale clinical trials comparing coronary computed tomographic angiography (CTCA) based care to exercise treadmill electrocardiography (ExECG)-based care in possible acute coronary syndrome patients The CT Coronary Angiography Compared to Exercise ECG (CT-COMPARE) study was a prospective randomized trial that compared dual source CTCA with ExECG as part of the standard of care in low-intermediate risk possible ACS patients presenting to the ED. The primary endpoints were the diagnostic performance measures and the hospital-based costs of CTCA-based care as compared to ECG-based care

Interventions

Coronary Computed Tomographic Angiography: electrocardiographically gated computed tomography of the heart with venous injection of iodinated contrast in order to evaluate the presence/absence of coronary artery disease. Subjects will be randomized to receive this diagnostic test once, as compared to standard of care. Duration of the test is 15-30 minutes.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

30 Years to 85 Years

Healthy volunteers

Inclusion criteria

Males greater or equal to 30 and females greater or equal to 40 years of age presenting to the ED with acute undifferentiated chest pain were eligible for inclusion in the trial. Inclusion criteria included intermediate probability of coronary artery disease according to the Cardiac Society of Australia and New Zealand guidelines; initial 12-lead ECG without evidence of acute ischemia, TIMI (Thrombolysis in Myocardial Infarction) risk score <4 and a negative first serum sensitive troponin-I with a 99th centile at <0.04 ng/ml (Access 2 immunoassay, Beckman-Coulter)

Exclusion criteria

Exclusion criteria were previous diagnosis of coronary artery disease; confirmed pregnancy or lactating female; history of severe reactive airway disease or current exacerbation; allergy or contraindication to iodinated contrast or beta-blockade medications; current atrial fibrillation; renal impairment (eGFR < 50ml/minute using the MDRD equation). To be eligible for randomization, subjects needed to be pain-free and potentially able to exercise on a treadmill.

Outcome results