Clinical trial NCT03791788: Multicenter Registry for Angiography-Derived Quantitative Flow Ratio
Official title: Multicenter Registry for Diagnostic Accuracy of Angiography-Derived Quantitative Flow Ratio to Evaluate the Hemodynamic Significance of Coronary Artery Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Keywords: Stable angina
Acute Myocardial Infarction
Fractional Flow Reserve
Quantitative Flow Ratio
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
name: Inje University
name: Dongsan Medical Center
name: Chosun University Hospital
First posted: 2019-01-03
Enrollment: 524
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

Brief summary: 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. to compare the changes of contrast QFR and fractional flow reserve (FFR) according to severity of percent diameter stenosis (%DS)
3. to evaluate prognostic implication of contrast QFR in comparison with FFR

Detailed description: Despite potential clinical benefits and abundant evidences of FFR-guided percutaneous coronary intervention (PCI), adoption rate of FFR is still low in real world practice, most likely due to use of additional resource and to concern about side effects of hyperemic agent. Therefore, several tools to derive FFR non-invasively has been developed based on computational fluid dynamics to overcome the limitations. One of the novel methods, the contrast quantitative flow ratio (QFR) is a computation of FFR based on 3-dimensional quantitative coronary angiography (QCA) combined with Thrombolysis in Myocardial Infarction (TIMI) frame counts adjustment without hyperemic agent infusion.

Although diagnostic performance of contrast QFR for evaluation of functional significance, using FFR as reference standard, is well validated in patients with stable ischemic heart disease (SIHD), there have been lack of evidence regarding the reliability of QFR for non-culprit stenosis in patients with AMI.

Therefore, the investigators sought to investigate the feasibility and diagnostic performance of contrast QFR for identifying the functional significance of coronary stenosis in all-comer patients with CAD. In addition, prognostic implication of contrast QFR will be also compared with that of FFR.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Diagnostic accuracy of QFR
timeFrame: through study completion, an average of 6 months
measure: Vessel-related composite outcome
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Sensitivity of QFR
timeFrame: through study completion, an average of 6 months
measure: Specificity of QFR
timeFrame: through study completion, an average of 6 months
measure: Correlation between QFR and FFR
timeFrame: through study completion, an average of 6 months
Other outcomes:
measure: Pre-specified substudy of exercise duration after PCI
timeFrame: through study completion, an average of 3 months
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Samsung Medical Center
name: Joo Myung Lee, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: