Clinical trial NCT04102917: Diagnostic Performance and Prognostic Ability of the QFR
Official title: The Catholic Imaging and Functional Research Cohort (C-iFR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Keywords: QFR
quantitative flow ratio
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
name: Seoul Saint Mary's Hospital
name: Incheon Saint Mary's Hospital
name: Seoul Saint Paul's Hospital
name: Uijeongbu Saint Mary's Hospital
First posted: 2019-09-25
Enrollment: 915
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 915 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, acute myocardial infarction with non-culprit stenotic lesion who underwent FFR measurement and were able to analyze QFR

Brief summary: 1. The primary technical endpoint was the diagnostic performance of the QFR against the FFR.
2. The primary clinical endpoint was target vessel failure (TVF) between two groups distributed by a QFR cut-off value of 0.8

Detailed description: The quantitative flow ratio (QFR) is a novel angiography-based tool used to assess functional ischemia caused by coronary stenosis. Computation of the fractional flow reserve (FFR) from coronary angiography is based on 3D reconstruction and fluid dynamics algorithms using a modified frame count; therefore, we do not need to induce hyperemia or perform invasive procedures with a pressure wire to measure it. During the past few years, the diagnostic accuracy of the QFR was investigated and showed favorable outcomes. However, data for patients with acute coronary syndrome are lacking. In addition, no data are available for the performance of the QFR in predicting clinical outcomes. We aim to evaluate the diagnostic performance of the QFR versus the FFR and their predictive abilities for clinical outcome in a real-world all-comer population.

The Catholic imaging and Functional Research (C-iFR) Cohort was designed to evaluate the diagnostic performance and clinical outcome predictive ability of the QFR in consecutive patients undergoing CAG and the FFR at 4 major cardiac centers in Korea from January 2012 to May 2018. All hospitals (Seoul St. Mary's Hospital, Seoul; St. Paul's Hospital, Seoul; Incheon St. Mary's Hospital, Incheon; Uijeongbu St. Mary's Hospital, Uijeongbu) perform a high volume of percutaneous coronary intervention (PCI) procedures, with more than 800 PCI procedures performed per year. This QFR registry includes demographic characteristics, clinical information, laboratory data, QFR findings, and FFR findings, with clinical outcome data collected over 4 years (a median of 2 years)

Eligibility criteria: Inclusion Criteria:

* subject ≥18 years
* Patients suspected with ischemic heart disease
* All-comer patients with SA, UA and AMI whose CAG results showed intermediate stenosis (50-70%) indicative of physiologic lesions
* Patients whose target vessels were able to analyze QFR

Exclusion Criteria: Patients with insufficient CAG data due to reasons below

* CAG data uploading error
* 2 projection angles \<25 degrees apart
* only 1 projection angle image exists
* images with suboptimal contrast filling
* images with too much panning or too much magnification
* containing an ostial lesion of the left main coronary artery or right coronary artery
* anatomical vessel problems including severe overlap, severe tortuosity, foreshortening, diffuse lesions, additional far distal lesion

Primary outcomes:
measure: Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR
timeFrame: follow up of 4 years (anticipated median duration : 2 years)
measure: Target vessel failure
timeFrame: follow up of 4 years (anticipated median duration : 2 years)
Secondary outcomes:
measure: Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR in subgroups with a borderline FFR (≥0.75, ≤0.85)
timeFrame: follow up of 4 years (anticipated median duration : 2 years)
measure: Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR in subgroups with complicated coronary lesions
timeFrame: follow up of 4 years (anticipated median duration : 2 years)
measure: All-cause death, cardiac death, nonfatal myocardial infarction, TLR and stroke
timeFrame: follow up of 4 years (anticipated median duration : 2 years)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Saint Mary's Hospital
state: Seochogu
Study officials:
affiliation: Seoul Saint Mary's Hospital
name: Kiyuk Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: