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

Primary Purpose

Heart Disease, Coronary, Chest Pain, Acute Coronary Syndrome

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CTFFR-Guided Group Management
SOC Group Management
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Disease, Coronary focused on measuring angina, coronary artery disease, coronary artery catheterization, coronary CT angiography, fractional flow reserve CT, emergency department

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beaumont Health System - Royal Oak

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SOC Group Management

CTFFR-Guided Group Management

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Catheterization Rate
Percent of patients undergoing heart catheterization

Secondary Outcome Measures

Diagnostic Effectiveness
Proportion of accurate triage using FFR measured at heart catheterization (CATH-FFR) among all patients triaged to heart catheterization by each strategy
Incidence of Major Adverse Cardiac Events
Incidence of any serious adverse event, defined as death, acute coronary syndrome or late unscheduled revascularization
Hospital Length of Stay
Time from admission to discharge from hospital in days

Full Information

First Posted
August 24, 2017
Last Updated
June 4, 2018
Sponsor
William Beaumont Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT03263806
Brief Title
The Computed Tomography-derived Fractional Flow Reserve STAT Trial
Acronym
CTFFR-STAT
Official Title
Computed Tomography-derived Fractional Flow Reserve in the Systematic Triage of Emergency Department Acute Chest Pain Patients to Treatment. (The CTFFR-STAT Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to lack of enrollment
Study Start Date
August 24, 2017 (Actual)
Primary Completion Date
April 4, 2018 (Actual)
Study Completion Date
April 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease, Coronary, Chest Pain, Acute Coronary Syndrome
Keywords
angina, coronary artery disease, coronary artery catheterization, coronary CT angiography, fractional flow reserve CT, emergency department

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOC Group Management
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CTFFR-Guided Group Management
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
CTFFR-Guided Group Management
Other Intervention Name(s)
Computed tomography - fractional flow reserve
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
SOC Group Management
Intervention Description
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
Primary Outcome Measure Information:
Title
Catheterization Rate
Description
Percent of patients undergoing heart catheterization
Time Frame
3 months after initial presentation
Secondary Outcome Measure Information:
Title
Diagnostic Effectiveness
Description
Proportion of accurate triage using FFR measured at heart catheterization (CATH-FFR) among all patients triaged to heart catheterization by each strategy
Time Frame
3 months after initial presentation
Title
Incidence of Major Adverse Cardiac Events
Description
Incidence of any serious adverse event, defined as death, acute coronary syndrome or late unscheduled revascularization
Time Frame
1 year after presentation
Title
Hospital Length of Stay
Description
Time from admission to discharge from hospital in days
Time Frame
An average of 2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilbert Raff, MD
Organizational Affiliation
Beaumont Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Health System - Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Computed Tomography-derived Fractional Flow Reserve STAT Trial

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