Assessing Diagnostic Value of Non-invasive FFR-CT in Coronary Care in the Emergency Department

HeartFlow, Inc.18 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Coronary Artery Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

For each enrolled patient, investigators used data from coronary CTA,along with the clinical data such as medical history and demographics todetermine the management plan for the patient. The investigator wouldthen also view the patient's FFR-CT results and determine themanagement plan for the patient with the additional information from theFFR-CT. None of the data was collected or analyzed due to the study'searly termination. No additional procedures occurred due to studytermination, and Patients were treated per standard clinical care.

Time frame: 30 days

Secondary Outcomes

Cost Utility Analysis

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 frame: 30 days

Rate of Major Adverse Coronary Events (MACE)

Major Adverse Coronary Events (MACE) is defined as the composite ofnonfatal stroke, nonfatal myocardial infarction and cardiovascular death.

Time frame: 30 days

Time to primary diagnosis

Time between when the patient first arrives to the emergency department to when the treating physician documents the primary diagnosis.

Time frame: Within 30 days

Time to discharge

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 frame: Within 30 days

Assessing Diagnostic Value of Non-invasive FFR-CT in Coronary Care in the Emergency Department

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes