Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05319119 |
| Other study ID # |
BHe |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 29, 2022 |
| Est. completion date |
April 29, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Henan Institute of Cardiovascular Epidemiology |
| Contact |
Gao, M.D |
| Phone |
8613937165590 |
| Email |
gaocy6802[@]163.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study is a retrospective, single-center study.This experiment aims to explore the
influence of CT-FFR as a relevant for revascularization on the prognosis of patients with
coronary heart disease, assessing concurrent on different basis the difference of prognosis
of patients with revascularization was analyzed, and the significance of revascularization
related by CT-FFR was analyzed.This study is a retrospective study. The treatment strategies
of all patients are based on the results of CAG，including coronary revascularization.After
calculating the CT-FFR value, the above doctors will formulate treatment strategies based on
the results and formulate treatment strategies retrospectively.
Description:
Research Objects and Criteria:Patients who had undergone coronary angiography and Coronary
Artery CTA in Fuwai Central China Cardiovascular Hospital.Preliminary screening of patients
is carried out in the medical record system, CT imaging workstation, and interventional
center imaging workstation to confirm data integrity.
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.
