Diagnostic Performance and Prognostic Ability of the QFR

NCT ID: NCT04102917

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 915 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2019-06-14

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)

Conditions

Ischemic Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

QFR group

915 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, acute myocardial infarction with non-culprit stenosis who underwent FFR measurement and were able to analyze QFR.

QFR assessment

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

QFR assessment

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

Intervention Type: DIAGNOSTIC_TEST

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Foundation of Korea

OTHER

Sponsor Role: collaborator

Seoul Saint Mary's Hospital

UNKNOWN

Sponsor Role: collaborator

Incheon Saint Mary's Hospital

UNKNOWN

Sponsor Role: collaborator

Seoul Saint Paul's Hospital

UNKNOWN

Sponsor Role: collaborator

Uijeongbu Saint Mary's Hospital

UNKNOWN

Sponsor Role: collaborator

Seoul St. Mary's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kiyuk Chang

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kiyuk Chang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul Saint Mary's Hospital

Locations

Seoul Saint Mary's Hospital

Seoul, Seochogu, South Korea

Countries

South Korea

Other Identifiers

XC18REDI0035

Identifier Type: -

Identifier Source: org_study_id