Diagnostic Performance of On-site Automatic Coronary Comp... | NCT06153927

Studies
Diagnostic Performance of On-site Automatic Coronary Computed Tomography Angiography-derived Fractional Flow Reserve

NCT06153927

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Dec 1, 2023Actual

Enrollment

332Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

CT-FFR

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 26, 2022Actual

Primary Completion Date

Jul 30, 2023Actual

Completion Date

Oct 31, 2023Actual

First Submitted Date

Nov 22, 2023

First Submission Date that Met QC Criteria

Nov 22, 2023

First Posted Date

Dec 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2023

Last Update Posted Date

Dec 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bon-Kwon Koo, Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Name	Class
Keimyung University Dongsan Medical Center	OTHER
Inje University Ilsan Paik Hospital	OTHER
Chosun University Hospital	OTHER
Severance Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The current study evaluated the diagnostic performance for myocardial ischemia of on-site automatic CCTA-derived FFR (CT-FFR) using a commercially available workstation as compared with invasive FFR as a reference. The diagnostic performance of CT-FFR was compared to that of CCTA diameter stenosis.

Detailed Description

This is a retrospective, multicenter, comparative, investigator-initiated study to evaluate the diagnostic performance of CT-FFR from routinely acquired CCTA data using the software HeartMedi+ 1.0 (AI Medic, Korea) to detect hemodynamically significant CAD. Patients who underwent CCTA within 90 days before invasive coronary angiography and FFR measurement will be screened in each participating center. After that, invasive coronary angiography, FFR data, and CCTA data will be anonymized and transferred to the independent core laboratories and analyzed in a blind fashion.

The presence of ischemia was defined as FFR ≤0.80. Anatomical obstructive stenosis was defined as diameter stenosis on CCTA ≥50%, and the diagnostic performance of CT-FFR and CCTA stenosis for ischemia was compared.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

332Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with CCTA and FFR assessment		Patients with CAD who underwent CCTA, invasive coronary angiography, and FFR measurement will be included in this study.	Diagnostic Test: CT-FFR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT-FFR	Diagnostic Test	CT-FFR was calculated using HeartMedi+ 1.0 according to the manufacturer's instructions	Patients with CCTA and FFR assessment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic accuracy of CT-FFR	Diagnostic accuracy of CT-FFR to detect hemodynamically significant CAD evaluated with an invasive FFR	At the time of test

Secondary Outcomes

Measure	Description	Time Frame
Spearman's correlation coefficient of CT-FFR with FFR	Spearman's correlation coefficient of CT-FFR with FFR	At the time of test
Agreement between CT-FFR and FFR	Bland-Altman analysis was used to demonstrate the agreement between CT-FFR and FFR.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults aged 20 years or older
individuals who had undergone ≥ 64 multidetector row CCTA within 90 days before invasive coronary angiography and FFR measurement
individuals who had not experienced any clinical events or significant clinical changes between the time of CCTA and invasive coronary angiography

Exclusion Criteria:

previous coronary intervention or coronary bypass surgery in the target vessel
invasive coronary angiography under unstable conditions
previous myocardial infarction at target vessel territory
congenital heart disease
moderate or severe valvular heart disease
previous valvular heart surgery
left ventricular ejection fraction ≤40% or left ventricular hypertrophy
previous cardiac device implantation
body mass index >35 kg/m2
poor FFR tracing quality
no information on the position of the FFR pressure wire
heart rate ≥100 beats/min during CCTA
CCTA calcium score ≥1000
no nitroglycerin prior to CCTA
CCTA slice thickness >1.0 mm
significant artifacts in CCTA

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

CAD patients who underwent CCTA, invasive coronary angiography, and FFR measurement will be included in this study.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bon-Kwon Koo, MD, PhD	Seoul National University Hospital	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided