CTFFR-STAT: The Computed Tomography-derived Fractional Flow Reserve STAT Trial

• Sponsor: William Beaumont Hospitals (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03263806
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.3
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Disease, Coronary; Chest Pain; Acute Coronary Syndrome	Diagnostic Test: CTFFR-Guided Group Management; Diagnostic Test: SOC Group Management	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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)
• Actual Study Start Date: Aug 24, 2017
• Actual Primary Completion Date: Apr 4, 2018
• Actual Study Completion Date: Apr 4, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Catheterization Rate [3 months after initial presentation]

   Percent of patients undergoing heart catheterization

Secondary Outcome Measures

1. Diagnostic Effectiveness [3 months after initial presentation]

   Proportion of accurate triage using FFR measured at heart catheterization (CATH-FFR) among all patients triaged to heart catheterization by each strategy

2. Incidence of Major Adverse Cardiac Events [1 year after presentation]

   Incidence of any serious adverse event, defined as death, acute coronary syndrome or late unscheduled revascularization

3. Hospital Length of Stay [An average of 2 days]

   Time from admission to discharge from hospital in days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beaumont Health System - Royal Oak	Royal Oak	Michigan	United States	48073

Sponsors and Collaborators

• William Beaumont Hospitals

Investigators

• Principal Investigator: Gilbert Raff, MD, Beaumont Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 26, 2018

More Information

Publications

None provided.

• Responsible Party: Gilbert L. Raff, MD, Director Cardiac MRI/CT, William Beaumont Hospitals
• ClinicalTrials.gov Identifier: NCT03263806
• Other Study ID Numbers: 2017-272
• First Posted: Aug 28, 2017
• Last Update Posted: Jul 3, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Gilbert L. Raff, MD, Director Cardiac MRI/CT, William Beaumont Hospitals: angina; coronary artery disease; coronary artery catheterization; coronary CT angiography; fractional flow reserve CT; emergency department
• Additional relevant MeSH terms: Heart Diseases; Acute Coronary Syndrome; Coronary Disease; Chest Pain

Study Results

Participant Flow

Recruitment Details	Emergency department patients who had a Cardiac CT scan, were screened for the study. The doctors interpreting the CT scan notifies the research coordinator regarding potential eligibility of the patient to the study.

Arm/Group Title	SOC Group Management	CTFFR-Guided Group Management
Arm/Group 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. 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	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. 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.
Period Title: Overall Study
STARTED	6	7
COMPLETED	0	0
NOT COMPLETED	6	7

Baseline Characteristics

Arm/Group Title	SOC Group Management	CTFFR-Guided Group Management	Total
Arm/Group 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. 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	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. 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.	Total of all reporting groups
Overall Participants	5	6	11
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	52	60.5	57
Sex: Female, Male (Count of Participants)
Female	3 60%	2 33.3%	5 45.5%
Male	2 40%	4 66.7%	6 54.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	5 100%	6 100%	11 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Study terminated with NO data collected.

Arm/Group Title	SOC Group Management	CTFFR-Guided Group Management
Arm/Group 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. 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	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. 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.
Measure Participants	0	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Study terminated with NO data collected.

Arm/Group Title	SOC Group Management	CTFFR-Guided Group Management
Arm/Group 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. 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	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. 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.
Measure Participants	0	0

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Study terminated with NO data collected.

Arm/Group Title	SOC Group Management	CTFFR-Guided Group Management
Arm/Group 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. 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	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. 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.
Measure Participants	0	0

4. Secondary Outcome

Title	Hospital Length of Stay
Description	Time from admission to discharge from hospital in days
Time Frame	An average of 2 days

Outcome Measure Data

Analysis Population Description

Study terminated with NO data collected.

Arm/Group Title	SOC Group Management	CTFFR-Guided Group Management
Arm/Group 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. 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	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. 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.
Measure Participants	0	0

Adverse Events

Time Frame	8 months
Arm/Group Title	SOC Group Management		CTFFR-Guided Group Management
Arm/Group 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. 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		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. 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.
All Cause Mortality
	SOC Group Management		CTFFR-Guided Group Management
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/6 (0%)
Serious Adverse Events
	SOC Group Management		CTFFR-Guided Group Management
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	SOC Group Management		CTFFR-Guided Group Management
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/6 (0%)

Limitations/Caveats

Study terminated early due to difficulty of enrollment.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.