Diagnostic accuracy of CCTA-derived versus angiography-derived quantitative flow ratio (CAREER) study : a prospective study protocol
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
INTRODUCTION: Coronary CT angiography (CCTA)-derived quantitative flow ratio (CT-QFR) is a novel non-invasive technology to assess the physiological significance of coronary stenoses, which enables fast and on-site computation of fractional flow reserve (FFR) from CCTA images. The objective of this investigator-initiated, prospective, single-centre clinical trial is to evaluate the diagnostic performance of CT-QFR with respect to angiography-derived QFR, using FFR as the reference standard.
METHODS AND ANALYSIS: A total of 216 patients who have at least one lesion with a diameter stenosis of 30%-90% in an artery with ≥2.0 mm reference diameter will be enrolled in the study. FFR will be measured during invasive coronary angiography. CT-QFR and QFR will be assessed in two independent core laboratories in a blinded fashion. The primary endpoint is the diagnostic accuracy of CT-QFR in identifying haemodynamically significant coronary stenosis with FFR as the reference standard. The major secondary endpoint is the non-inferiority of CT-QFR compared with QFR in the patients without extensively calcified lesions.
ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of Huadong Hospital Affiliated to Fudan University (2020K192). Outcomes will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences.
TRIAL REGISTRATION NUMBER: NCT04665817.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
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| Enthalten in: |
BMJ open - 12(2022), 6 vom: 23. Juni, Seite e055481 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Weng, Tingwen [VerfasserIn] |
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| Links: |
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| Themen: |
Adult cardiology |
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| Anmerkungen: |
Date Completed 27.06.2022 Date Revised 16.07.2022 published: Electronic ClinicalTrials.gov: NCT04665817 Citation Status MEDLINE |
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| doi: |
10.1136/bmjopen-2021-055481 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM342597485 |
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a INTRODUCTION: Coronary CT angiography (CCTA)-derived quantitative flow ratio (CT-QFR) is a novel non-invasive technology to assess the physiological significance of coronary stenoses, which enables fast and on-site computation of fractional flow reserve (FFR) from CCTA images. The objective of this investigator-initiated, prospective, single-centre clinical trial is to evaluate the diagnostic performance of CT-QFR with respect to angiography-derived QFR, using FFR as the reference standard | ||
| 520 | |a METHODS AND ANALYSIS: A total of 216 patients who have at least one lesion with a diameter stenosis of 30%-90% in an artery with ≥2.0 mm reference diameter will be enrolled in the study. FFR will be measured during invasive coronary angiography. CT-QFR and QFR will be assessed in two independent core laboratories in a blinded fashion. The primary endpoint is the diagnostic accuracy of CT-QFR in identifying haemodynamically significant coronary stenosis with FFR as the reference standard. The major secondary endpoint is the non-inferiority of CT-QFR compared with QFR in the patients without extensively calcified lesions | ||
| 520 | |a ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of Huadong Hospital Affiliated to Fudan University (2020K192). Outcomes will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT04665817 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a adult cardiology | |
| 650 | 4 | |a cardiomyopathy | |
| 650 | 4 | |a coronary heart disease | |
| 650 | 4 | |a coronary intervention | |
| 650 | 4 | |a ischaemic heart disease | |
| 700 | 1 | |a Gan, Qian |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Zehang |e verfasserin |4 aut | |
| 700 | 1 | |a Guan, Shaofeng |e verfasserin |4 aut | |
| 700 | 1 | |a Han, Wenzheng |e verfasserin |4 aut | |
| 700 | 1 | |a Zhai, Xinrong |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Ming |e verfasserin |4 aut | |
| 700 | 1 | |a Qi, Lin |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Cheng |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Yang |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Liang |e verfasserin |4 aut | |
| 700 | 1 | |a Chang, Xifeng |e verfasserin |4 aut | |
| 700 | 1 | |a Tu, Shengxian |e verfasserin |4 aut | |
| 700 | 1 | |a Qu, Xinkai |e verfasserin |4 aut | |
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