Status:
TERMINATED
Assessing Diagnostic Value of Non-invasive FFR-CT (Fractional Flow Reserve - Computed Tomography) in Coronary Care in the Emergency Department
Lead Sponsor:
HeartFlow, Inc.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective multi-center study. All clinically stable, symptomatic patients who present to the emergency department (ED) or observation unit with suspected coronary artery disease (CAD) and ...
Detailed Description
This is a prospective multi-center study. All clinically stable, symptomatic patients who present to the ED or observation unit with suspected CAD and who have at least one ≥40% lesion and no lesions ...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Clinically stable, symptomatic patients who present to ED/observation unit with suspected CAD
- CCTA shows at least one ≥40% lesion and no lesions \>90% in at least one major epicardial vessel
- FFR-CT processed successfully (if applicable)
- EKG with no acute ischemic changes
- Willing to comply with all aspects of the protocol, including adherence to follow up visit
- Agrees to be included in the study
- Able to provide written informed consent
Exclusion
- CCTA showing no ≥40% lesion in a major epicardial vessel
- CCTA showing a lesion \>90% in a major epicardial vessel
- CCTA showing other incidental, non-cardiac findings requiring admission, e.g., pneumonia, pulmonary embolism, or aortic dissection
- Uninterpretable CCTA which is not of diagnostic quality
- Coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) prior to CCTA acquisition
- Left main lesion \>50%
- Confirmed acute coronary syndrome (acute myocardial infarction or unstable angina)
- Known complex congenital heart disease or any history of coronary artery disease
- Patients with tachycardia or significant arrhythmia which cannot be adequately controlled with medications to allow CTA
- Any active, serious, life-threatening disease with a life expectancy of less than 2 months
- Inability to comply with follow-up requirements
- Currently enrolled in another study utilizing FFR-CT or in an investigational trial that involves a non-approved cardiac drug or device
- Persons under the protection of justice, guardianship, or curatorship
Key Trial Info
Start Date :
July 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 14 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05325112
Start Date
July 15 2022
End Date
November 14 2022
Last Update
January 19 2023
Active Locations (2)
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1
UMass Memorial Hospital
Worcester, Massachusetts, United States, 01605
2
University Hospital Clevelan
Cleveland, Ohio, United States, 44106