Comprehensive Cardiothoracic Dual Source CT for the Early Triage of Patients With Acute Chest Pain

Completed · Phase 4

Conditions studied: Chest Pain Syndrome

In brief

The purpose of this research is to determine the efficiency of a single dual source computed tomography (CT-DSCT) protocol to establish or exclude acute coronary syndrome (ACS), pulmonary embolism (PE) or aortic dissection (AD) as compared to the individual protocols. Endpoints aim to compare the rate of emergency department (ED) discharge, length of hospital stay, the diagnostic imaging test utilization, and the costs between the comprehensive and the standard protocol strategy in patients with undifferentiated chest discomfort or shortness of breath with a component of chest discomfort.

Key facts

Study ID

NCT01067456

Run by

Massachusetts General Hospital

People needed

59

Starts

2008-05-01

Expected to finish

2010-01-01

Last updated by the study team

2017-12-22

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females >30 years of age in sinus rhythm
• Willing and able to provide written informed consent
• Undifferentiated chest discomfort or shortness of breath with a component of chest discomfort within the last 24 hours
• Intermediate likelihood of MI, pulmonary embolism (PE), or aortic dissection (AD) as determined by ED providers after completion of standard initial clinical evaluation
• ED providers independently decide that the patient's care plan should include a coronary, PE, or AD CT.
• Female patients must be either of non-childbearing potential (i.e., surgically sterilized or post menopausal [≥ 12 consecutive months without menses]) or must have a negative pregnancy test

You may not qualify if…

• Positive cardiac biomarkers (elevated serum creatine phosphate (CK) with elevated CK-MB isoform and/or elevated troponin)
• Diagnostic ECG changes (e.g., >1 mm ST-segment elevation or depression in two anatomically contiguous leads)
• Known history of CAD (i.e., past myocardial infarction, prior coronary stent Placement, and/or coronary artery bypass graft surgery)
• Known history of thoracic aortic disease (i.e., thoracic aortic aneurysm > 5cm in diameter, history of aortic dissection, and/or history of thoracic aortic aneurysm repair (via open surgery or stent-graft placement))
• Known history of pulmonary embolism
• Heart rate > 100 beats per minute
• Systolic blood pressure <105 mmHg
• Oxygen saturation < 90%
• Any cardiac arrhythmia causing hemodynamic compromise
• Serum creatinine clearance <60 mL/min by Cockcroft-Gault
• Known allergy to iodinated contrast agents
• Subjects on metformin therapy that are unable or unwilling to discontinue therapy for 48 hours after CT procedure

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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