Coronary Artery DiseaseNCT05593120
Evaluation of Health Economics for Noninvasive Coronary Fractional Flow Reserve Measurement Technology
An observational study of Coronary Artery Disease, run by Shenzhen Raysight Intelligent Medical Technology Co., Ltd. at 1 site in China.
Trial summary
To determine whether, in a Chinese population of patients presenting to Wuhan Asia Heart Hospital, Fractional Flow Reserve Derived from Coronary Computed Tomography Angiography (CT-FFR) as a default test is noninferior in terms of total costs when compared to routine clinical pathway recommended by the investigator… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CT-FFR and Routine care
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 29 Jun 2022to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Subjects with at least 1 lesion with a percent diameter stenosis (DS%) 30%-90% in a coronary artery with a ≥2.0 mm reference vessel diameter diagnosed on coronary CTA, suspected CAD
Who may be able to join
- Aged over 18
- Providing written informed consent
- No contraindication to CTA
- At least 1 lesion with a percent diameter stenosis (DS%) 30%-90% in a coronary artery with a ≥2.0 mm reference vessel diameter diagnosed on coronary CTA
Who cannot join
- Acute coronary syndrome or myocardial infarction requiring urgent revascularization
- Prior PCI or CABG surgery
- Allergic to contrast
- BMI>35 at the time of coronary CTA
- Advanced renal impairment
- Significant valve disease (severe aortic stenosis or regurgitation; severe mitral regurgitation)
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- Life expectancy <12 months
- Repeated enrollment
- Any other factors that the researchers consider not suitable for inclusion or completion of this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022
Xiaojing Ma, 15902751799, xjm9027581@163.com
About this study
To determine whether, in a Chinese population of patients presenting to Wuhan Asia Heart Hospital, Fractional Flow Reserve Derived from Coronary Computed Tomography Angiography (CT-FFR) as a default test is noninferior in terms of total costs when compared to routine clinical pathway recommended by the investigator and the institution's heart team.
Read the detailed description
The 2021 ACC/AHA Guidelines now highlight use of CT-FFR as a front-line pathway to help in "the diagnosis of vessel-specific ischemia and to guide decision-making regarding the use of coronary revascularization". Previous observational PLATFORM study, which compared the use of CT-FFR with standard assessment of patients with stable chest pain enrolled from 11 European sites, demonstrated that management based on CT-FFR was both safe and associated with a significantly lower frequency of invasive angiograms demonstrating no significant coronary artery disease (CAD). Furthermore, the CT-FFR strategy appeared to be economically attractive in this observational study, and was supported by the 2016 National Institute for Health and Care Excellence (NICE) guidance. In contrast, the FORECAST randomized trial included 1400 patients with stable chest pain from 11 centres in the UK, and the results showed that a strategy of CCTA with selective CT-FFR in patients with stable angina did not differ significantly from standard clinical care pathways in cost or clinical outcomes, but did reduce the use of invasive coronary angiography. As abovementioned, the population enrolled in the previous studies were from different western countries, and the cost analysis results of CT-FFR application in different countries are diverse in terms of health care economics.
To date, however, the cost-effectiveness and clinical safety impact of using CT-FFR instead of other tests in the initial evaluation of patients with suspected coronary artery disease has not been tested in a prospective clinical trial in China.
The OVERALL OBJECTVE of this prospective, observational study is to compare resource utilization, time-effectiveness and clinical safety in subjects with suspected CAD receiving standard practice evaluation and treatment versus subjects receiving CT-FFR-guided evaluation and treatment in order to further inform patients, health care providers, and other stakeholders about which technologies are most cost-effective and efficient in the diagnosis of CAD. The hypothesis this CERTAIN trial is that CT-FFR would be associated with (1) lower overall costs; (2) shorter time period between initial consultation and definitive management plan; (3) better patient experience.
The 2 strategies for the CERTAIN trial are:
[A] TEST GROUP: All patients will be assessed and managed according to the results of CT-FFR test, assuming they have no prespecified contraindications to CT coronary angiography. The result of the CT-FFR will be conveyed to the supervising physician within 24 hours and will be used to determine the subsequent management plan.
[B] REFERENCE GROUP: All patients will be assessed and managed exactly as they are usually treated by the investigator and the institution's heart team according to standard practice in Wuhan Asia Heart Hospital.
- Conditions
- Coronary Artery Disease
- Being tested
- CT-FFR, Routine care
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-FFRDiagnostic test
In the test group all patients who are eligible for CTA will undergo CTA as their default test. Those patients with any coronary stenosis 30%-90% data in at least one major epicardial vessel will be referred for CT-FFR. In patients in whom CT-FFR analysis is performed, FFR will be derived for all vessels. CT-FFR will be evaluated in a blinded fashion with a "Coarse-to-Fine Subpixel" algorithm for lumen contour. The data derived from this test will determine their management strategy.
Routine careDiagnostic test
All patients in the routine care group will be assessed according to their current conventional pathways that are based upon routine practice in Wuhan Asia Heart Hospital. The trial will encourage the routine and standard assessment and management of all patients (anticipated outcomes include ETT, stress echo, stress MR, nuclear perfusion, CTA, CT calcium, invasive CA, reassurance).
| Study group | Role | What they receive |
|---|---|---|
| CT-FFR | All patients will be assessed and managed according to the results of CT-FFR test, assuming they have no prespecified contraindications to CT coronary angiography. The result of the CT-FFR will be conveyed to the supervising physician within 24 hours and will be used to determine the subsequent management plan. Receives: Diagnostic Test: CT-FFR | |
| Routine care | All patients will be assessed and managed exactly as they are usually treated by the investigator and the institution's heart team according to routine practice in Wuhan Asia Heart Hospital. Receives: Diagnostic Test: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resource utilisation
To determine whether, in a Chinese population of patients presenting to Wuhan Asia Heart Hospital, CT-FFR as a default test is noninferior in terms of total costs when compared to routine clinical pathway recommended by the investigator and the institution's heart team. Comparison of resource utilization between two groups at 180 days (+30/-15 days).
Measured: 6 months
Secondary outcomes (1)
time period between initial consultation and definitive management plan
Comparison of time period between initial consultation and definitive management plan between two groups during 180 days (+30/-15 days).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start29 Jun 2022
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wuhan Asia Heart Hospital
- Responsible party
- Sponsor
- Investigators
- Xiaojing Ma, Principal investigator, Wuhan Asia Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593120
- Sponsor's protocol ID
- Health Economics
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Health Economics for Noninvasive Coronary Fractional Flow Reserve Measurement Technology
- ClinicalTrials.gov ID
- NCT05593120
- Acronym / sponsor ID
- Health Economics
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shenzhen Raysight Intelligent Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Wuhan Asia Heart Hospital
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether, in a Chinese population of patients presenting to Wuhan Asia Heart Hospital, Fractional Flow Reserve Derived from Coronary Computed Tomography Angiography (CT-FFR) as a default test is noninferior in terms of total costs when compared to routine clinical pathway recommended by the investigator and the institution's heart team.
Detailed description
The 2021 ACC/AHA Guidelines now highlight use of CT-FFR as a front-line pathway to help in "the diagnosis of vessel-specific ischemia and to guide decision-making regarding the use of coronary revascularization". Previous observational PLATFORM study, which compared the use of CT-FFR with standard assessment of patients with stable chest pain enrolled from 11 European sites, demonstrated that management based on CT-FFR was both safe and associated with a significantly lower frequency of invasive angiograms demonstrating no significant coronary artery disease (CAD). Furthermore, the CT-FFR strategy appeared to be economically attractive in this observational study, and was supported by the 2016 National Institute for Health and Care Excellence (NICE) guidance. In contrast, the FORECAST randomized trial included 1400 patients with stable chest pain from 11 centres in the UK, and the results showed that a strategy of CCTA with selective CT-FFR in patients with stable angina did not differ significantly from standard clinical care pathways in cost or clinical outcomes, but did reduce the use of invasive coronary angiography. As abovementioned, the population enrolled in the previous studies were from different western countries, and the cost analysis results of CT-FFR application in different countries are diverse in terms of health care economics.
To date, however, the cost-effectiveness and clinical safety impact of using CT-FFR instead of other tests in the initial evaluation of patients with suspected coronary artery disease has not been tested in a prospective clinical trial in China.
The OVERALL OBJECTVE of this prospective, observational study is to compare resource utilization, time-effectiveness and clinical safety in subjects with suspected CAD receiving standard practice evaluation and treatment versus subjects receiving CT-FFR-guided evaluation and treatment in order to further inform patients, health care providers, and other stakeholders about which technologies are most cost-effective and efficient in the diagnosis of CAD. The hypothesis this CERTAIN trial is that CT-FFR would be associated with (1) lower overall costs; (2) shorter time period between initial consultation and definitive management plan; (3) better patient experience.
The 2 strategies for the CERTAIN trial are:
[A] TEST GROUP: All patients will be assessed and managed according to the results of CT-FFR test, assuming they have no prespecified contraindications to CT coronary angiography. The result of the CT-FFR will be conveyed to the supervising physician within 24 hours and will be used to determine the subsequent management plan.
[B] REFERENCE GROUP: All patients will be assessed and managed exactly as they are usually treated by the investigator and the institution's heart team according to standard practice in Wuhan Asia Heart Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-FFR | – | Diagnostic Test: CT-FFRAll patients will be assessed and managed according to the results of CT-FFR test, assuming they have no prespecified contraindications to CT coronary angiography. The result of the CT-FFR will be conveyed to the supervising physician within 24 hours and will be used to determine the subsequent management plan. |
| Routine care | – | Diagnostic Test: Routine careAll patients will be assessed and managed exactly as they are usually treated by the investigator and the institution's heart team according to routine practice in Wuhan Asia Heart Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with at least 1 lesion with a percent diameter stenosis (DS%) 30%-90% in a coronary artery with a ≥2.0 mm reference vessel diameter diagnosed on coronary CTA, suspected CAD
Key inclusion criteria (4 listed)
- Aged over 18
- Providing written informed consent
- No contraindication to CTA
- At least 1 lesion with a percent diameter stenosis (DS%) 30%-90% in a coronary artery with a ≥2.0 mm reference vessel diameter diagnosed on coronary CTA
Key exclusion criteria (9 listed)
- Acute coronary syndrome or myocardial infarction requiring urgent revascularization
- Prior PCI or CABG surgery
- Allergic to contrast
- BMI>35 at the time of coronary CTA
- Advanced renal impairment
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 |
|---|---|---|
| CT-FFRIn the test group all patients who are eligible for CTA will undergo CTA as their default test. Those patients with any coronary stenosis 30%-90% data in at least one major epicardial vessel will be referred for CT-FFR. In patients in whom CT-FFR analysis is performed, FFR will be derived for all vessels. CT-FFR will be evaluated in a blinded fashion with a "Coarse-to-Fine Subpixel" algorithm for lumen contour. The data derived from this test will determine their management strategy. | Diagnostic test | CT-FFR |
| Routine careAll patients in the routine care group will be assessed according to their current conventional pathways that are based upon routine practice in Wuhan Asia Heart Hospital. The trial will encourage the routine and standard assessment and management of all patients (anticipated outcomes include ETT, stress echo, stress MR, nuclear perfusion, CTA, CT calcium, invasive CA, reassurance). | Diagnostic test | Routine care |
Primary outcome
Resource utilisation
Time frame: 6 months
To determine whether, in a Chinese population of patients presenting to Wuhan Asia Heart Hospital, CT-FFR as a default test is noninferior in terms of total costs when compared to routine clinical pathway recommended by the investigator and the institution's heart team. Comparison of resource utilization between two groups at 180 days (+30/-15 days).
1 secondary outcome
time period between initial consultation and definitive management plan
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
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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.
Xiaojing Ma principal investigator
Wuhan Asia Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Shenzhen Raysight Intelligent Medical Technology Co., Ltd. at 1 site in China.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 25 Oct 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaojing Ma (15902751799, xjm9027581@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resource utilisation (time frame: 6 months). 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 25 Oct 2022.