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

NCT05325112 | Terminated

• 1 other identifier: CP- 909-001
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cost Utility Analysis

  30 days

• Rate of Major Adverse Coronary Events (MACE)

  30 days

• Time to primary diagnosis

  Within 30 days

• Time to discharge

  Within 30 days

Study Arms (2)

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: FFRCT

Control Group

Sites who have CCTA but not FFR-CT incorporated into the ED/observation unit.

Interventions

FFRCT DIAGNOSTIC_TEST

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

FFR-CT Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Age ≥18 years
• Clinically stable, symptomatic patients who present to ED/observation unit with suspected CAD
• CCTA shows at least one ≥40% lesion and no lesions \>90% in at least one major epicardial vessel
• FFR-CT processed successfully (if applicable)
• EKG with no acute ischemic changes
• Willing to comply with all aspects of the protocol, including adherence to follow up visit
• Agrees to be included in the study
• Able to provide written informed consent

You may not qualify if:

• CCTA showing no ≥40% lesion in a major epicardial vessel
• CCTA showing a lesion \>90% in a major epicardial vessel
• CCTA showing other incidental, non-cardiac findings requiring admission, e.g., pneumonia, pulmonary embolism, or aortic dissection
• Uninterpretable CCTA which is not of diagnostic quality
• Coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) prior to CCTA acquisition
• Left main lesion \>50%
• Confirmed acute coronary syndrome (acute myocardial infarction or unstable angina)
• Known complex congenital heart disease or any history of coronary artery disease
• Patients with tachycardia or significant arrhythmia which cannot be adequately controlled with medications to allow CTA
• Any active, serious, life-threatening disease with a life expectancy of less than 2 months
• Inability to comply with follow-up requirements
• Currently enrolled in another study utilizing FFR-CT or in an investigational trial that involves a non-approved cardiac drug or device
• Persons under the protection of justice, guardianship, or curatorship

Sponsors & Collaborators

• HeartFlow, Inc.: lead

Study Sites (2)

UMass Memorial Hospital

Worcester, Massachusetts, 01605, United States

Location

University Hospital Clevelan

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Sadeer Al-Kindi, MD

  University Hospitals Cleveland

  PRINCIPAL INVESTIGATOR

• Sneha Chinai, MD

  UMass Memorial Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 13, 2022
• Study Start: July 15, 2022
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: January 19, 2023

Record last verified: 2023-01

Locations

US (2)