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

NCT ID: NCT05325112

Last Updated: 2023-01-19

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2022-11-14

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

FFR-CT Group

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

FFRCT

Intervention Type: DIAGNOSTIC_TEST

FFRCT 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.

No interventions assigned to this group

Interventions

FFRCT

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HeartFlow, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sadeer Al-Kindi, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland

Sneha Chinai, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Memorial Health

Locations

UMass Memorial Hospital

Worcester, Massachusetts, United States

University Hospital Clevelan

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CP- 909-001

Identifier Type: -

Identifier Source: org_study_id