Clinical trial NCT05593120: Evaluation of Health Economics for Noninvasive Coronary Fractional Flow Reserve Measurement Technology
Official title: Evaluation of Health Economics for Noninvasive Coronary Fractional Flow Reserve Measurement Technology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Wuhan Asia Heart Hospital
First posted: 2022-10-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* Life expectancy \<12 months
* Repeated enrollment
* Any other factors that the researchers consider not suitable for inclusion or completion of this study.

Primary outcomes:
measure: Resource utilisation
timeFrame: 6 months
Secondary outcomes:
measure: time period between initial consultation and definitive management plan
timeFrame: 6 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
Study officials:
affiliation: Wuhan Asia Heart Hospital
name: Xiaojing Ma
role: PRINCIPAL_INVESTIGATOR
References: