Assessing Diagnostic Value of Non-invasive FFR-CT in Coronary Care in the Emergency Department (ADVANCE-ED)

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

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: FFR-CT

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 Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospital Clevelan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FFR-CT Group; Sites who have CCTA and FFR-CT analysis incorporated into their standard evaluation of chest pain in the ED/observation unit.	Diagnostic test: FFR-CT; FFR-CT is a diagnostic test following a CCTA to help diagnose and treat coronary artery disease.
Control Group; Sites who have CCTA but not FFR-CT incorporated into the ED/observation unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Within 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.	30 days

Collaborators and Investigators

• Sponsor: HeartFlow, Inc.
• Investigators: Principal Investigator: Sadeer Al-Kindi, MD, University Hospitals Cleveland; Principal Investigator: Sneha Chinai, MD, UMass Memorial Health

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): November 14, 2022
• Study Completion (Actual): November 14, 2022

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: CP- 909-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No