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

Coronary Artery Disease Clinical Trial

— ADVANCE-ED  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05325112
• Other study ID #: CP- 909-001
• Status: Terminated
• Start date: July 15, 2022
• Est. completion date: November 14, 2022

Study information

• Verified date: January 2023
• Source: HeartFlow, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: November 14, 2022
• Est. primary completion date: November 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Emergencies

Intervention

Diagnostic Test:
• FFRCT
FFRCT is a diagnostic test following a CCTA to help diagnose and treat coronary artery disease.

Locations

Country	Name	City	State
United States	University Hospital Clevelan	Cleveland	Ohio
United States	UMass Memorial Hospital	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
HeartFlow, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Rate of Major Adverse Coronary Events (MACE)		30 days
Secondary	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
Secondary	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