Diagnostic accuracy of CCTA-derived versus angiography-derived quantitative flow ratio (CAREER) study: a prospective study protocol
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 i...
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BMJ Publishing Group
2022-06-01
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| author | Liang Zhang Yang Chen Cheng Li Ming Li Shaofeng Guan Xinkai Qu Tingwen Weng Qian Gan Zehang Li Wenzheng Han Xinrong Zhai Lin Qi Xifeng Chang Shengxian Tu |
| author_facet | Liang Zhang Yang Chen Cheng Li Ming Li Shaofeng Guan Xinkai Qu Tingwen Weng Qian Gan Zehang Li Wenzheng Han Xinrong Zhai Lin Qi Xifeng Chang Shengxian Tu |
| author_sort | Liang Zhang |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-2ae1c5b10916414e941c58bde33e9107 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-2ae1c5b10916414e941c58bde33e91072025-01-28T04:05:08ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-055481Diagnostic accuracy of CCTA-derived versus angiography-derived quantitative flow ratio (CAREER) study: a prospective study protocolLiang Zhang0Yang Chen1Cheng Li2Ming Li3Shaofeng Guan4Xinkai Qu5Tingwen Weng6Qian Gan7Zehang Li8Wenzheng Han9Xinrong Zhai10Lin Qi11Xifeng Chang12Shengxian Tu13Guangdong Eye Institute, Department of Ophthalmology, Guangdong Provincial People`s Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China1Karolinska Institutet, Stockholm, SwedenDepartment of Anesthesiology and Perioperative medicine, Shanghai Key Laboratory of Anesthesiology and Brain Functional Modulation, Clinical Research Center for Anesthesiology and Perioperative Medicine, Translational Research Institute of Brain and Brain-Like Intelligence, Shanghai Fourth People`s Hospital, School of Medicine, Tongji University, Shanghai, People`s Republic of China2University of Southern California, Los Angeles, CA, USADepartment of Cardiology, Huadong Hospital Affiliated to Fudan University, Shanghai, ChinaDepartment of Cardiology, Huadong Hospital Affiliated to Fudan University, Shanghai, ChinaDepartment of Cardiology, Huadong Hospital Affiliated to Fudan University, Shanghai, ChinaDepartment of Cardiology, Huadong Hospital Affiliated to Fudan University, Shanghai, ChinaSchool of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, ChinaDepartment of Cardiology, Huadong Hospital Affiliated to Fudan University, Shanghai, ChinaDepartment of Cardiology, Huadong Hospital Affiliated to Fudan University, Shanghai, ChinaShanghai Jiao Tong Affiliated Sixth People`s Hospital, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, Shanghai, ChinaDepartment of Cardiology, Huadong Hospital Affiliated to Fudan University, Shanghai, ChinaBiomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, ChinaIntroduction 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.https://bmjopen.bmj.com/content/12/6/e055481.full |
| spellingShingle | Liang Zhang Yang Chen Cheng Li Ming Li Shaofeng Guan Xinkai Qu Tingwen Weng Qian Gan Zehang Li Wenzheng Han Xinrong Zhai Lin Qi Xifeng Chang Shengxian Tu Diagnostic accuracy of CCTA-derived versus angiography-derived quantitative flow ratio (CAREER) study: a prospective study protocol BMJ Open |
| title | Diagnostic accuracy of CCTA-derived versus angiography-derived quantitative flow ratio (CAREER) study: a prospective study protocol |
| title_full | Diagnostic accuracy of CCTA-derived versus angiography-derived quantitative flow ratio (CAREER) study: a prospective study protocol |
| title_fullStr | Diagnostic accuracy of CCTA-derived versus angiography-derived quantitative flow ratio (CAREER) study: a prospective study protocol |
| title_full_unstemmed | Diagnostic accuracy of CCTA-derived versus angiography-derived quantitative flow ratio (CAREER) study: a prospective study protocol |
| title_short | Diagnostic accuracy of CCTA-derived versus angiography-derived quantitative flow ratio (CAREER) study: a prospective study protocol |
| title_sort | diagnostic accuracy of ccta derived versus angiography derived quantitative flow ratio career study a prospective study protocol |
| url | https://bmjopen.bmj.com/content/12/6/e055481.full |
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