Diagnostic Accuracy of Multislice CT Angiography for Acute Chest Pain

Diagnostic Accuracy of Multislice CT Angiography for Acute Chest Pain - Assessment of Chest Pain Utilizing a Triple Rule Out Evaluation With Computed Tomography (ACUTE CT) Trial

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00855231

Acronym

ACUTE CT

Enrollment

102

Registered

2009-03-04

Start date

2006-07-31

Completion date

2009-09-30

Last updated

2017-11-27

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

Conditions

Acute Coronary Syndrome, Aortic Dissection, Chest Pain, Pulmonary Embolism

Keywords

Acute coronary syndrome, Coronary artery disease, cardiac imaging, computed tomography

Brief summary

The ACUTE CT trial is designed to test whether the assessment of chest structures by high-resolution multislice computed tomography (CT) provides equivalent diagnostic accuracy for patient with acute chest pain or other potential cardiac symptoms as compared to a standard of care evaluation.

Detailed description

Adults at low to intermediate risk of acute coronary syndrome who present to the Emergency Department with symptoms suggestive of cardiac ischemia will undergo a blinded cardiac CT followed by a standard of care (SOC) strategy. Significant coronary artery disease on CT (coronary stenosis \>50%) will be compared to an adjudicated diagnosis derived from clinical data and other diagnostic tests based on the SOC strategy. Costs for the SOC evaluation will be collected and compared to a CT-based evaluation. Patients will be followed for 3 years after enrollment to evaluate prognosis.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Inclusion criteria

* Low to intermediate risk of angina with a TIMI ACS Risk Score ≤ 4 * chest pain or other symptoms suggestive of ACS within 24 hours * male ≥30 years or female ≥45 years old * at least one cardiac risk factor * no obvious cause for symptoms.

Exclusion criteria

* known CAD * ST segment elevation, new left bundle branch block or dynamic ECG changes * creatinine ≥1.8 g/dL * pregnant or lactating female * hemodynamic or respiratory instability * ongoing bronchospasm * known iodinated contrast allergy * atrial fibrillation or irregular heart rate

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy of CT compared to standard of care evaluation	3 months

Secondary

Measure	Time frame
Cost savings of CT-based evaluation compared to the standard of care evaluation	3 months

Countries

United States

Outcome results