Status:
TERMINATED
The Computed Tomography-derived Fractional Flow Reserve STAT Trial
Lead Sponsor:
Corewell Health East
Conditions:
Heart Disease, Coronary
Chest Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is designed to directly compare Standard Care and CT fractional flow reserve (CTFFR) for diagnosis of chest pain patients with definite coronary artery disease (CAD) on heart computed tomog...
Detailed Description
New or worsening chest discomfort is the most common symptom of coronary artery disease (CAD), which is plaque build-up in the arteries that supply the heart muscle with blood. Chest pain is one of th...
Eligibility Criteria
Inclusion
- Emergency department chest pain suspicious for ACS based on history and physical examination.
- At least one biomarker (troponin) and electrocardiogram with no evidence of definite ACS.
- A completed CCTA demonstrating \>50% but \<90% stenosis of at least one coronary artery branch.
- CCTA test images with sufficient diagnostic quality for CTFFR analysis.
- Ability and willingness to provide informed consent.
Exclusion
- Left main coronary stenosis of 50% or greater.
- CCTA lesions demonstrating stenosis \>90% ("subtotal"), or complex, high-risk plaque characteristics resulting in an a priori recommendation for triage to CATH by the CCTA interpreting physician.
- Attending physician a priori decision for CATH.
- Previous coronary stent, coronary bypass or prior known myocardial infarction.
- Clinical instability, such as hypotension, signs of shock, and/or accelerating chest pain requiring admission.
- Pregnancy
Key Trial Info
Start Date :
August 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2018
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03263806
Start Date
August 24 2017
End Date
April 4 2018
Last Update
July 3 2018
Active Locations (1)
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1
Beaumont Health System - Royal Oak
Royal Oak, Michigan, United States, 48073