Assessing Diagnostic Value of Non-invasive FFR-CT (Fractional Flow Reserve - Computed Tomography) in Coronary Care in the Emergency Department

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: FFRCT

• Registration Number: NCT05325112
• Lead Sponsor: HeartFlow, Inc.

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 who have at least one ≥40% lesion and no lesion \>90% confirmed by CCTA (Coronary Computed Tomography Angiogram) are eligible for enrollment once their CCTA has been completed and their FFR-CT (if applicable) has been ordered. All enrolling sites will have CCTA incorporated into their standard evaluation of chest pain in the ED/observation unit. Non-control sites will have CCTA and FFR-CT analysis incorporated into their standard evaluation of chest pain in the ED/observation unit.

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 \<90% lesion in a major vessel, confirmed by CCTA, are eligible for enrollment once their CCTA has been completed and FFR-CT (if applicable) has been ordered. All enrolling sites will have CCTA incorporated into their standard evaluation of chest pain in the ED/observation unit. Non-control sites will have CCTA and FFR-CT analysis incorporated into their standard evaluation of chest pain in the ED/observation unit.

All participating sites will provide demographics, medical history, CCTA images, FFR-CT (for non-control sites), the decision plan post CCTA and pre FFR-CT (for non-control sites), length of stay for patients in the ED/observation unit/hospital, billing reports (UB-04 preferred), 30-day clinical outcomes, and any other hospital or office visits, imaging, and/or procedural data completed prior to the follow-up 30-day visit. Sites which do not have FFR-CT incorporated into the ED/observation unit will be control sites.

Study Timeline

• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-13
• Study Start: 2022-07-15
• Primary Completion: 2022-11-14
• Study Completion: 2022-11-14
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. Age ≥18 years
2. Clinically stable, symptomatic patients who present to ED/observation unit with suspected CAD
3. CCTA shows at least one ≥40% lesion and no lesions >90% in at least one major epicardial vessel
4. FFR-CT processed successfully (if applicable)
5. EKG with no acute ischemic changes
6. Willing to comply with all aspects of the protocol, including adherence to follow up visit
7. Agrees to be included in the study
8. Able to provide written informed consent

Exclusion Criteria

1. CCTA showing no ≥40% lesion in a major epicardial vessel
2. CCTA showing a lesion >90% in a major epicardial vessel
3. CCTA showing other incidental, non-cardiac findings requiring admission, e.g., pneumonia, pulmonary embolism, or aortic dissection
4. Uninterpretable CCTA which is not of diagnostic quality
5. Coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) prior to CCTA acquisition
6. Left main lesion >50%
7. Confirmed acute coronary syndrome (acute myocardial infarction or unstable angina)
8. Known complex congenital heart disease or any history of coronary artery disease
9. Patients with tachycardia or significant arrhythmia which cannot be adequately controlled with medications to allow CTA
10. Any active, serious, life-threatening disease with a life expectancy of less than 2 months
11. Inability to comply with follow-up requirements
12. Currently enrolled in another study utilizing FFR-CT or in an investigational trial that involves a non-approved cardiac drug or device
13. Persons under the protection of justice, guardianship, or curatorship

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FFR-CT Group	FFRCT	Sites who have CCTA and FFR-CT analysis incorporated into their standard evaluation of chest pain in the ED/observation unit.

Primary Outcome Measures

Name	Time	Method
Reclassification rate between the coronary management plan based on the review of the CCTA alone compared to the coronary management plan based on the review of the CCTA and the FFR-CT analysis.	30 days

Secondary Outcome Measures

Name	Time	Method
Rate of Major Adverse Coronary Events (MACE)	30 days
Cost Utility Analysis	30 days	Cost measurements to include length of stay in the emergency department and in the hospital overall, secondary coronary artery disease testing, and invasive procedures done.
Time to discharge	Within 30 days	Time between when the patient first arrives to the emergency department to the time the patient was discharged from the emergency department or the hospital.
Time to primary diagnosis	Within 30 days	Time between when the patient first arrives to the emergency department to when the treating physician documents the primary diagnosis.

Trial Locations

Locations (2)

University Hospital Clevelan; 🇺🇸 Cleveland, Ohio, United States

UMass Memorial Hospital; 🇺🇸 Worcester, Massachusetts, United States