Heart Disease, CoronaryCTFFR-STATNCT03263806
The Computed Tomography-derived Fractional Flow Reserve STAT Trial
A study testing CTFFR-Guided Group Management and SOC Group Management in people with Heart Disease, Coronary and Chest Pain, run by Corewell Health East at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease, Coronary, Chest Pain, Acute Coronary Syndrome
- What is being tested?
- CTFFR-Guided Group Management and SOC Group Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2017to 4 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beaumont Health System - Royal Oak
Royal Oak, Michigan, 48073
About this study
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)
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.
Read the 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.
- Conditions
- Heart Disease, Coronary, Chest Pain, Acute Coronary Syndrome
- Being tested
- CTFFR-Guided Group Management, SOC Group Management
- Keywords
- angina, coronary artery disease, coronary artery catheterization, coronary CT angiography, fractional flow reserve CT, emergency department
- Medical subject headings
- Coronary Disease, Chest Pain, Acute Coronary Syndrome, Angina Pectoris, Coronary Artery Disease, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTFFR-Guided Group ManagementDiagnostic test
Also called Computed tomography - fractional flow reserve
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.
SOC Group ManagementDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| SOC Group Management | Active comparator | 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. Receives: Diagnostic Test: SOC Group Management |
| CTFFR-Guided Group Management | Experimental | 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. Receives: Diagnostic Test: CTFFR-Guided Group Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheterization Rate
Percent of patients undergoing heart catheterization
Measured: 3 months after initial presentation
Secondary outcomes (3)
Diagnostic Effectiveness
Proportion of accurate triage using FFR measured at heart catheterization (CATH-FFR) among all patients triaged to heart catheterization by each strategy
Measured: 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
Measured: 1 year after presentation
Hospital Length of Stay
Time from admission to discharge from hospital in days
Measured: An average of 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start24 Aug 2017
- Primary completion4 Apr 2018
- Study completion4 Apr 2018
Why it stopped: Terminated due to lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Disease, CoronaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilbert L. Raff, MD, Corewell Health East
- Investigators
- Gilbert Raff, MD, Principal investigator, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263806
- Sponsor's protocol ID
- 2017-272
- Acronym
- CTFFR-STAT
- Status last verified
- Jun 2018
- First submitted
- 24 Aug 2017
- Last updated
- 3 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03263806
- Acronym / sponsor ID
- CTFFR-STAT / 2017-272
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to lack of enrollment
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Posted 3 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC Group Management | Active comparator | Diagnostic Test: SOC Group ManagementAttending 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. |
| CTFFR-Guided Group Management | Experimental | Diagnostic Test: CTFFR-Guided Group ManagementPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTFFR-Guided Group ManagementAlso: Computed tomography - fractional flow reservePatients 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. | Diagnostic test | CTFFR-Guided Group Management |
| SOC Group ManagementPatients 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 | Diagnostic test | SOC Group Management |
Primary outcome
Catheterization Rate
Time frame: 3 months after initial presentation
Percent of patients undergoing heart catheterization
3 secondary outcomes
Diagnostic Effectiveness
Time frame: 3 months after initial presentation
Incidence of Major Adverse Cardiac Events
Time frame: 1 year after presentation
Hospital Length of Stay
Time frame: An average of 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilbert Raff, MD principal investigator
Beaumont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTFFR-Guided Group Management and SOC Group Management in people with Heart Disease, Coronary and Chest Pain, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catheterization Rate (time frame: 3 months after initial presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.