Diagnostic Performance and Prognostic Ability of the QFR

Ischemic Heart Disease Clinical Trial

Official title:

The Catholic Imaging and Functional Research Cohort (C-iFR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04102917
• Other study ID #: XC18REDI0035
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: June 14, 2019

Study information

• Verified date: September 2019
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 915
• Est. completion date: June 14, 2019
• Est. primary completion date: May 31, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• QFR assessment
The quantitative flow ratio (QFR) is a novel angiography-based method for noninvasive functional assessment of intermediate coronary lesions.

Locations

Country	Name	City	State
Korea, Republic of	Seoul Saint Mary's Hospital	Seoul	Seochogu

Sponsors (6)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital	Incheon Saint Mary's Hospital, National Research Foundation of Korea, Seoul Saint Mary's Hospital, Seoul Saint Paul's Hospital, Uijeongbu Saint Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR	the diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of the QFR=0.80 for identifying an FFR=0.8 as the reference standard	follow up of 4 years (anticipated median duration : 2 years)
Primary	Target vessel failure	target vessel failure (TVF) between two groups distributed by a QFR cut-off value of 0.8	follow up of 4 years (anticipated median duration : 2 years)
Secondary	Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR in subgroups with a borderline FFR (=0.75, =0.85)	the sensitivity, specificity, negative predictive value, positive predictive value of the QFR=0.80 for identifying an FFR=0.8 as the reference standard in subgroups with a borderline FFR (=0.75, =0.85)	follow up of 4 years (anticipated median duration : 2 years)
Secondary	Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR in subgroups with complicated coronary lesions	the sensitivity, specificity, negative predictive value, positive predictive value of the QFR=0.80 for identifying an FFR=0.8 as the reference standard in subgroups with complicated coronary lesions, such as bifurcation lesions, a large intraluminal plaque volume, a low mean flow rate, a long lesion length, calcification, tandem lesions, and a previous history of coronary intervention	follow up of 4 years (anticipated median duration : 2 years)
Secondary	All-cause death, cardiac death, nonfatal myocardial infarction, TLR and stroke	all-cause death, cardiac death, nonfatal myocardial infarction, TLR and stroke between two groups distributed by a QFR cut-off value of 0.80	follow up of 4 years (anticipated median duration : 2 years)