The Computed Tomography-derived Fractional Flow Reserve STAT Trial (CTFFR-STAT)

Computed Tomography-derived Fractional Flow Reserve in the Systematic Triage of Emergency Department Acute Chest Pain Patients to Treatment. (The CTFFR-STAT Trial)

This study is designed to directly compare Standard Care and CT fractional flow reserve (CTFFR) for diagnosis of chest pain patients with definite coronary artery disease (CAD) on heart computed tomography (CT) scans.

Study Overview

• Status: Terminated
• Conditions: Chest Pain; Acute Coronary Syndrome; Heart Disease, Coronary
• Intervention / Treatment: Diagnostic test: SOC Group Management; Diagnostic test: CTFFR-Guided Group Management

Detailed Description

New or worsening chest discomfort is the most common symptom of coronary artery disease (CAD), which is plaque build-up in the arteries that supply the heart muscle with blood. Chest pain is one of the most common reasons for emergency department (ED) visits, with an estimated 8 million new cases every year. Evaluation of chest pain is expensive and time consuming, even though 75% of the time it is not due to CAD. It is necessary to carefully define the amount of CAD, even if initial tests reveal no heart attack, because this symptom may progress to heart attack and death if missed.

Coronary artery computed tomography angiography of the heart (CCTA) is one of the most sensitive tests to detect serious CAD in appropriately selected patients.In 85% of acute chest pain (ACP) ED cases tested by CCTA, no CAD or very mild CAD is found, leading to rapid discharge or an alternative diagnosis. However, in the 15% of patients with significant CAD found on CCTA, further evaluation with either stress testing or heart catheterization, and/or hospital admission is required. Since 2015, Beaumont Health hospitals have employed a new FDA-approved test, called CT fractional flow reserve (CTFFR), that can analyze flow down the heart arteries by computer analysis of the original CT images. Results from an analysis of 147 patients suggest that 67% of the time, CTFFR showed no significant flow limitation, providing for the potential to defer invasive testing or treatment for a trial of medical therapy.

The use of CTFFR on ED patients is novel, and it is not yet part of the standard of care (SOC). Standard care of patients with definite CAD on CCTA continues to be hospital admission, stress testing and/or heart catheterization for further diagnosis. Both CTFFR and standard care continue to be used at Beaumont Health, and it is important to determine if one or the other diagnostic strategy is superior. This study is designed to directly compare standard care and CTFFR for diagnosis and management of ACP patients with definite CAD on CCTA.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Health System - Royal Oak

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Emergency department chest pain suspicious for ACS based on history and physical examination.
• At least one biomarker (troponin) and electrocardiogram with no evidence of definite ACS.
• A completed CCTA demonstrating >50% but <90% stenosis of at least one coronary artery branch.
• CCTA test images with sufficient diagnostic quality for CTFFR analysis.
• Ability and willingness to provide informed consent.

Exclusion Criteria:

• Left main coronary stenosis of 50% or greater.
• CCTA lesions demonstrating stenosis >90% ("subtotal"), or complex, high-risk plaque characteristics resulting in an a priori recommendation for triage to CATH by the CCTA interpreting physician.
• Attending physician a priori decision for CATH.
• Previous coronary stent, coronary bypass or prior known myocardial infarction.
• Clinical instability, such as hypotension, signs of shock, and/or accelerating chest pain requiring admission.
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SOC Group Management; Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.	Diagnostic test: SOC Group Management; Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment
Experimental: CTFFR-Guided Group Management; Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.	Diagnostic test: CTFFR-Guided Group Management; Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway.; Other Names: Computed tomography - fractional flow reserve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheterization Rate	Percent of patients undergoing heart catheterization	3 months after initial presentation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Effectiveness	Proportion of accurate triage using FFR measured at heart catheterization (CATH-FFR) among all patients triaged to heart catheterization by each strategy	3 months after initial presentation
Incidence of Major Adverse Cardiac Events	Incidence of any serious adverse event, defined as death, acute coronary syndrome or late unscheduled revascularization	1 year after presentation
Hospital Length of Stay	Time from admission to discharge from hospital in days	An average of 2 days

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Investigators: Principal Investigator: Gilbert Raff, MD, Beaumont Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2017
• Primary Completion (Actual): April 4, 2018
• Study Completion (Actual): April 4, 2018

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (Actual): August 28, 2017

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: coronary artery disease; angina; emergency department; coronary CT angiography; coronary artery catheterization; fractional flow reserve CT
• Additional Relevant MeSH Terms: Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Heart Diseases; Coronary Disease; Chest Pain; Acute Coronary Syndrome
• Other Study ID Numbers: 2017-272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No