Fractional Flow Reserve Derived From CT Related Treatment

March 31, 2022 updated by: Chuanyu Gao, Henan Institute of Cardiovascular Epidemiology

The Impact Of Revascularization Related By Blood Fractional Flow Reserve Calculated By Coronary Artery CTA On Prognosis

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Fuwai Central China Cardiovascular Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diagnosed or suspected coronary heart disease patients with typical symptoms or objective evidence of ischemia such as ECG, exercise treadmill, coronary CTA or CAG

Description

Inclusion Criteria:

  • ①Diagnosed or suspected coronary heart disease patients during the diagnosis and treatment process

    • 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:

  • ① The presence of severe artifact, dislocation or calcification in coronary CTA images affects FFRCT measurement. ② Contraindications to antiplatelet drugs

    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death or Myocardial infarction
Time Frame: 1 year
Cardiovascular, non-cardiovascular and undetermined death or Target vessel related and non-target vessel related MI
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart failure
Time Frame: 1 year,2 years
Heart failure
1 year,2 years
Non-target vessel revascularization
Time Frame: 1 year,2 years
The ischemia driven and non-ischemia driven non-target vessel revascularization
1 year,2 years
Cardiac death
Time Frame: 1 year,2 years
Cardiovascular death
1 year,2 years
Target vessel revascularization
Time Frame: 1 year,2 years
The ischemia driven and non-ischemia driven target vessel revascularization
1 year,2 years
Myocardial infarction
Time Frame: 1 year,2 years
Target vessel related and non-target vessel related MI
1 year,2 years
Stroke
Time Frame: 1 year,2 years
Stroke
1 year,2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Institute of Cardiovascular Epidemiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 29, 2022

Primary Completion (ANTICIPATED)

April 6, 2022

Study Completion (ANTICIPATED)

April 29, 2022

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

March 31, 2022

First Posted (ACTUAL)

April 8, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHe

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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