Clinical trial NCT05325112: Assessing Diagnostic Value of Non-invasive FFR-CT (Fractional Flow Reserve - Computed Tomography) in Coronary Care in the Emergency Department
Official title: ADVANCE-ED: Assessing Diagnostic Value of Non-invasive FFR-CT in Coronary Care in the Emergency Department
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Lead sponsor: HeartFlow, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-13
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinically stable, symptomatic patients who present to the ED with suspected coronary artery disease and no history of coronary artery disease, and who while in the ED have a CCTA performed which shows at least one ≥40% lesion and no lesions \>90% in a major epicardial vessel, and a successfully processed FFR-CT (if applicable).

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 30 days
Secondary outcomes:
measure: Cost Utility Analysis
timeFrame: 30 days
measure: Rate of Major Adverse Coronary Events (MACE)
timeFrame: 30 days
measure: Time to primary diagnosis
timeFrame: Within 30 days
measure: Time to discharge
timeFrame: Within 30 days
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Hospital
state: Massachusetts
city: Cleveland
country: United States
facility: University Hospital Clevelan
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland
name: Sadeer Al-Kindi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMass Memorial Health
name: Sneha Chinai, MD
role: PRINCIPAL_INVESTIGATOR
References: