Evaluation of Health Economics for Noninvasive Coronary Fractional Flow Reserve Measurement Technology
1 other identifier
observational
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 29, 2022
CompletedFirst Submitted
Initial submission to the registry
October 20, 2022
CompletedFirst Posted
Study publicly available on registry
October 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedOctober 25, 2022
October 1, 2022
5 months
October 20, 2022
October 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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).
6 months
Secondary Outcomes (1)
time period between initial consultation and definitive management plan
6 months
Study Arms (2)
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.
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.
Interventions
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.
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).
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaojing Ma
Wuhan Asia Heart Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2022
First Posted
October 25, 2022
Study Start
June 29, 2022
Primary Completion
November 30, 2022
Study Completion
December 30, 2022
Last Updated
October 25, 2022
Record last verified: 2022-10