Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT01067456
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT01067456
Study Brief:
Protocol Section:
NCT01067456