Multicenter Registry for Angiography-Derived Quantitative Flow Ratio

NCT03791788 | Completed DMC

• 1 other identifier: QFR2018-11-112-002
• Study Type: observational
• Target: 524
• Locations: 1 country
• Sites: 5

Brief Summary

1. 1.to investigate the feasibility and diagnostic performance of contrast quantitative flow ratio (QFR) for identifying the functional significance of intermediate degree stenotic lesions in all-comer patients with coronary artery disease (CAD) including presentation of acute myocardial infarction (AMI) with non-culprit lesion.
2. 2.to compare the changes of contrast QFR and fractional flow reserve (FFR) according to severity of percent diameter stenosis (%DS)
3. 3.to evaluate prognostic implication of contrast QFR in comparison with FFR

Conditions

Ischemic Heart Disease

Keywords

Stable angina; Acute Myocardial Infarction; Fractional Flow Reserve; Quantitative Flow Ratio

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy of QFR

  Diagnostic accuracy of contrast QFR to predict FFR lower than 0.8

  through study completion, an average of 6 months

• Vessel-related composite outcome

  a composite of cardiac death, vessel-related myocardial infarction, and vessel-related ischemia driven revascularization

  through study completion, an average of 2 year

Secondary Outcomes (3)

• Sensitivity of QFR

  through study completion, an average of 6 months

• Specificity of QFR

  through study completion, an average of 6 months

• Correlation between QFR and FFR

  through study completion, an average of 6 months

Other Outcomes (1)

• Pre-specified substudy of exercise duration after PCI

  through study completion, an average of 3 months

Study Arms (1)

QFR Group

Patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, NSTEMI (non ST-segment elevation myocardial infarction), or STEMI (ST-segment elevation myocardial infarction) with non-culprit stenosis who underwent FFR measurement and were able to analyze QFR.

Diagnostic Test: QFR assessment

Interventions

QFR assessment DIAGNOSTIC_TEST

QFR measurement in order to evaluate functional significance of epicardial stenosis and to compare the response of QFR for worsening stenosis severity, FFR value as reference standard

QFR Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

320 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, non ST-segment elevation MI, or ST-segment elevation MI with non-culprit stenosis who underwent FFR measurement and were able to analyze QFR

You may qualify if:

• Subject must be ≥18 years
• Patients suspected with ischemic heart disease
• Patients with intermediate degree of coronary artery stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery with FFR measurement
• Patients who were able to analyze QFR
• Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and he/she or his/her legally authorized representative provides

You may not qualify if:

• Left main (LM) or right coronary artery (RCA) ostial lesion
• Severe overlap of stenotic segments
• Severe tortuosity of target vessel
• Poor angiographic image quality precluding contour detection
• No optimal images with angles ≥ 25o

Sponsors & Collaborators

• Samsung Medical Center: lead
• Seoul National University Hospital: collaborator
• Inje University: collaborator
• Dongsan Medical Center: collaborator
• Chosun University Hospital: collaborator

Study Sites (5)

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang-si, South Korea

Location

Chosun University Hospital

Gwangju, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Myocardial Ischemia; Angina, Stable

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joo Myung Lee, MD, MPH, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: January 3, 2019
• Study Start: April 30, 2016
• Primary Completion: October 1, 2022
• Study Completion: December 31, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

KR (5)