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| Name | Class |
|---|---|
| Seoul National University Hospital | OTHER |
| Inje University | OTHER |
| Dongsan Medical Center | OTHER |
| Chosun University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of QFR | Sensitivity of contrast QFR to predict FFR lower than 0.8 | through study completion, an average of 6 months |
| Specificity of QFR | Specificity of contrast QFR to predict FFR lower than 0.8 |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-specified substudy of exercise duration after PCI | residual functional SYNTAX score calculated using post-PCI QFR will be used to define functional complete revascularization. Pre- and Post-PCI exercise treadmill test within 3 months window from PCI | through study completion, an average of 3 months |
Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Joo Myung Lee, MD, MPH, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keimyung University Dongsan Medical Center | Daegu | South Korea | ||||
| Inje University Ilsan Paik Hospital |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
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| OTHER |
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| through study completion, an average of 6 months |
| Correlation between QFR and FFR | Correlation between QFR and FFR | through study completion, an average of 6 months |
| Goyang-si |
| South Korea |
| Chosun University Hospital | Gwangju | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |