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| Name | Class |
|---|---|
| National Research Foundation of Korea | OTHER |
| Seoul Saint Mary's Hospital | UNKNOWN |
| Incheon Saint Mary's Hospital | UNKNOWN |
| Seoul Saint Paul's Hospital |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QFR assessment | Diagnostic Test | The quantitative flow ratio (QFR) is a novel angiography-based method for noninvasive functional assessment of intermediate coronary lesions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR in subgroups with a borderline FFR (≥0.75, ≤0.85) | the sensitivity, specificity, negative predictive value, positive predictive value of the QFR≤0.80 for identifying an FFR≤0.8 as the reference standard in subgroups with a borderline FFR (≥0.75, ≤0.85) | follow up of 4 years (anticipated median duration : 2 years) |
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Inclusion Criteria:
Exclusion Criteria: Patients with insufficient CAG data due to reasons below
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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
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| Name | Affiliation | Role |
|---|---|---|
| Kiyuk Chang, MD, PhD | Seoul Saint Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Saint Mary's Hospital | Seoul | Seochogu | 06591 | South Korea |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| UNKNOWN |
| Uijeongbu Saint Mary's Hospital | UNKNOWN |
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| Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR in subgroups with complicated coronary lesions | the sensitivity, specificity, negative predictive value, positive predictive value of the QFR≤0.80 for identifying an FFR≤0.8 as the reference standard in subgroups with complicated coronary lesions, such as bifurcation lesions, a large intraluminal plaque volume, a low mean flow rate, a long lesion length, calcification, tandem lesions, and a previous history of coronary intervention | follow up of 4 years (anticipated median duration : 2 years) |
| All-cause death, cardiac death, nonfatal myocardial infarction, TLR and stroke | all-cause death, cardiac death, nonfatal myocardial infarction, TLR and stroke between two groups distributed by a QFR cut-off value of 0.80 | follow up of 4 years (anticipated median duration : 2 years) |