Fractional Flow Reserve Derived From CT Related Treatment
NCT ID: NCT05319119
Last Updated: 2022-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2022-03-29
2022-04-29
Brief Summary
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Detailed Description
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Standard constrain:①Diagnosed or suspected coronary heart disease patients during the diagnosis and treatment process.②From December 2017 to December 2020, coronary artery CTA and coronary angiography were performed simultaneously in Fuwai Central China Cardiovascular Hospital. (coronary artery CTA before the coronary angiography, but no more than 28 days apart).③Age 18 to 75 years old.
Exclusion criteria:①Severe artefacts, misalignment, or calcifications in coronary CTA images affect CT-FFR measurements.② Contraindications to antiplatelet drugs③ Patients with acute myocardial infarction within 6 months.④ PCI or CABG or heart transplantation and other operations that may affect the outcome⑤ Severe heart failure⑥ Pregnant patients⑦ Combined tumor patients⑧ Have a history of other serious heart disease⑨Contraindications to coronary angiography drop out standard:① Abnormal research results ② Failure to achieve the expected therapeutic effect due to other serious diseases ③ Violation of the research plan④ Lost to follow-up ⑤ The relevant data is seriously missing, which affects the experimental data
Case grouping method:
1. CT-FFR related Group:①Coronary diseased artery CTFFR\>80%, secondary prevention of coronary heart disease ② Coronary diseased artery CTFFR≤80% revascularization at the lesion site and regular medication after PCI
2. Coronary angiography related Group:①Coronary diseased artery CTFFR≤80%, coronary angiography decision does not require revascularization but apply coronary heart disease secondary prevention medication. ②Coronary diseased artery CTFFR\>80%,However, revascularization was performed according to conventional angiographic decisions and postoperative regular service was performed.For multivessel disease, although coronary revascularization is performed, there are still diseased artery with CTFFR≤80% and no revascularization is performed.
End point：①Primary endpoint: all-cause death/cardiac death,②Secondary endpoints:myocardial infarction, target vessel repeat revascularization, brain stroke readmission for cardiovascular events, abnormal laboratory tests, new-onset heart failure, or progression to severe heart failure Statistics and analysis of research data：The data collected in the group at different recording times are selected if they satisfy the normal distribution.
Repeated measures ANOVA; if normal distribution is not met, rank sum test is used.The data between groups were analyzed by one-way analysis of variance. For count data (include rate) use X² or Fisher's exact probability test.Statistically significant at p \< 0.05 Use the Kaplan-Meier method to describe the survival rate of each group and draw the survival curve, and then use the Log-rank Test Calculate the test statistic, with p \< 0.05 as statistically significant.The factor p \< 0.05 obtained from the univariate Cox analysis was included in the multivariate Cox proportional wind in the risk model, hazard ratios, 95% confidence intervals were calculated and multivariate adjustment analysis was performed. Take p \< 0.05 as having statistical significance.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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1.CT-FFR Related Group
Coronary diseased artery CTFFR\>80%, secondary prevention of coronary heart disease;Coronary diseased artery CTFFR≤80% revascularization at the lesion site and regular medication after PCI
No interventions assigned to this group
Coronary Angiography Related Group
Coronary diseased artery CTFFR≤80%, coronary angiography decision does not require revascularization but apply coronary heart disease secondary prevention medication;Coronary diseased artery CTFFR\>80%,However, revascularization was performed according to conventional angiographic decisions and postoperative regular service was performed.For multivessel disease, although coronary revascularization is performed, there are still diseased artery with CTFFR≤80% and no revascularization is performed.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* From December 2017 to December 2020, coronary CTA and coronary artery CTA were performed simultaneously in Huazhong Fuwai Hospital.
Patients with CAG (coronary CTA before coronary angiography after CAG, no more than 28 days apart).
③Age 18 to 75 years old.
Exclusion Criteria
* Patients with acute myocardial infarction within 6 months④ PCI or CABG or heart transplantation and other operations that may affect the outcome ⑤ Severe heart failure⑥ Pregnant patients⑦ Combined tumor patients⑧ Life expectancy \< 2 years⑨ Have a history of other serious heart disease⑩ Contraindications for CAG⑪ Not suitable to participate in this researcher due to other reasons
18 Years
75 Years
ALL
No
Sponsors
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Henan Institute of Cardiovascular Epidemiology
OTHER
Responsible Party
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Chuanyu Gao
Professor
Locations
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Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BHe
Identifier Type: -
Identifier Source: org_study_id
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