NCT04102917

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
915

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

6.4 years

First QC Date

September 15, 2019

Last Update Submit

September 23, 2019

Conditions

Ischemic Heart Disease

Keywords

QFRquantitative flow ratio

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (3)

  • Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR in subgroups with a borderline FFR (≥0.75, ≤0.85)

    follow up of 4 years (anticipated median duration : 2 years)

  • Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR in subgroups with complicated coronary lesions

    follow up of 4 years (anticipated median duration : 2 years)

  • All-cause death, cardiac death, nonfatal myocardial infarction, TLR and stroke

    follow up of 4 years (anticipated median duration : 2 years)

Study Arms (1)

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.

Diagnostic Test: QFR assessment

Interventions

QFR assessmentDIAGNOSTIC_TEST

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

QFR group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • CAG data uploading error
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Saint Mary's Hospital

Seoul, Seochogu, 06591, South Korea

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Kiyuk Chang, MD, PhD

    Seoul Saint Mary's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

September 15, 2019

First Posted

September 25, 2019

Study Start

January 1, 2012

Primary Completion

May 31, 2018

Study Completion

June 14, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)