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Assessment of CT-FFR in Patients With CCS: A Prospective Multicenter Cohort Study (ACCURATE-PRO)

2026年8月9日 更新者：Second Affiliated Hospital, Zhejiang University, School of Medicine

Assessment of Coronary Computed Tomography-Derived Fractional Flow Reserve in Patients With Chronic Coronary Syndrome: A Prospective Multicenter Cohort Study

The ACCURATE-PRO study is an investigator-initiated, prospective, multicenter, observational, real-world cohort study. The core objective in managing chronic coronary syndrome (CCS) is to identify clinically significant myocardial ischemia to guide treatment decisions and improve long-term prognosis. While coronary computed tomography angiography (CCTA) is a crucial non-invasive anatomical imaging tool, it has limitations in determining the functional significance of coronary stenosis. Computed tomography-derived fractional flow reserve (CT-FFR) provides this functional assessment non-invasively based on CCTA images. However, there is a lack of systematic, prospective, multicenter evidence regarding its clinical value in risk stratification, treatment decision support, and prognostic evaluation for a continuous, real-world spectrum of CCS patients in China.

This study aims to evaluate the relationship between abnormal CT-FFR results and the risk of 1-year major adverse clinical events in CCS patients undergoing CCTA and CT-FFR. The study hypothesizes that abnormal CT-FFR is associated with a higher risk of 12-month major adverse clinical events, and that CT-FFR results are significantly correlated with subsequent treatment strategies, providing important value in risk stratification and mid-to-long-term prognosis.

The trial plans to consecutively enroll approximately 3,000 patients across multiple clinical centers in China. Eligible participants must be 18 years or older, have a clinical diagnosis of CCS, and have successfully obtained CT-FFR results following a CCTA examination. Patients will be excluded if they have acute coronary syndrome (such as STEMI, NSTEMI, or acute unstable angina), unanalyzable CT-FFR results/image quality, or non-cardiac conditions limiting their life expectancy to less than one year.

Since this is an observational study, it will not alter routine clinical care pathways or assign interventions. The primary exposure factor analyzed will be the lowest CT-FFR result per patient, comparing an abnormal CT-FFR group (≤ 0.80) to a normal CT-FFR group (> 0.80).

Participants will be followed up via telephone, outpatient visits, or hospitalization at 6, 12, 24, and 60 months after enrollment. The primary endpoint is a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization within 1 year after enrollment. Key secondary endpoints include the occurrence of the primary endpoint at 24 and 60 months, target vessel failure (a composite of cardiac death, target vessel MI, or target vessel revascularization), stroke, health economics analysis, and the association between CT plaque characteristics and clinical outcomes.

調査の概要

状態

募集

条件

研究の種類

観察的

入学 (推定)

3000

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 中国
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310009
        • 募集
        • Second Affiliated Hospital, School of Medicine, Zhejiang University

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

The study population consists of patients with chronic coronary syndrome (CCS) who undergo coronary computed tomography angiography (CCTA) and CT-derived fractional flow reserve (CT-FFR) evaluation as part of their routine clinical care. Participants are consecutively recruited from multiple tertiary medical centers across China to ensure a representative real-world cohort. This population reflects the broad clinical spectrum of CCS patients encountered in actual practice, encompassing a wide range of coronary disease severity as assessed by non-invasive functional imaging.

説明

Inclusion Criteria:

  • Age ≥ 18 years.
  • Clinical diagnosis of chronic coronary syndrome (CCS).
  • Completed coronary computed tomography angiography (CCTA) examination and successfully obtained CT-derived fractional flow reserve (CT-FFR) results.
  • The subject or their legal representative voluntarily participates in this study and has signed the written informed consent form.

Exclusion Criteria:

  • Acute coronary syndrome (ACS), including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), or acute episodes of unstable angina.
  • Unable to obtain valid CT-FFR results, or the image quality is insufficient to support analysis.
  • Pregnant patients or those who intend to become pregnant during the study period.
  • Non-cardiac comorbidities indicating a life expectancy of less than one year.
  • Failure to sign the informed consent form.
  • Inability to complete the follow-up or explicit refusal to participate in the follow-up.
  • Patients with cognitive impairment or psychiatric disorders confirmed by clinical diagnosis or investigator assessment.
  • Patients who are illiterate or semi-literate, or who, due to any visual impairment or reading/writing disability, are unable to independently read the subject information sheet without assistance and are unable to personally provide written informed consent.
  • Any other conditions deemed unsuitable for participation in this study by the investigators

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
Abnormal CT-FFR Cohort
Patients diagnosed with chronic coronary syndrome who underwent coronary computed tomography angiography (CCTA) and computed tomography-derived fractional flow reserve (CT-FFR) evaluation, with a lowest per-patient CT-FFR value of ≤ 0.80.
Normal CT-FFR Cohort
Patients diagnosed with chronic coronary syndrome who underwent coronary computed tomography angiography (CCTA) and computed tomography-derived fractional flow reserve (CT-FFR) evaluation, with a lowest per-patient CT-FFR value of > 0.80.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Composite of All-cause Death, Myocardial Infarction (MI), or Ischemia-driven Revascularization
時間枠：12 months after enrollment
The primary endpoint is defined as the composite occurrence of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization.
12 months after enrollment

二次結果の測定

結果測定
メジャーの説明
時間枠
Primary Endpoint Excluding Periprocedural MI
時間枠：12 months after enrollment
The primary composite endpoint of all-cause death, myocardial infarction, or ischemia-driven revascularization, excluding periprocedural myocardial infarction.
12 months after enrollment
Composite of All-cause Death, Myocardial Infarction (MI), or Ischemia-driven Revascularization
時間枠：24 and 60 months after enrollment
The primary endpoint is defined as the composite occurrence of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization.
24 and 60 months after enrollment
Individual Components of the Primary Endpoint
時間枠：12 months after enrollment
The occurrence of the individual components of the primary composite endpoint, analyzed separately. These include all-cause death, myocardial infarction, and ischemia-driven revascularization.
12 months after enrollment
Target Vessel Failure (TVF)
時間枠：12, 24, and 60 months after enrollment
A composite endpoint including cardiac death, target vessel myocardial infarction (MI), or target vessel revascularization.
12, 24, and 60 months after enrollment
Health Economics Analysis
時間枠：12, 24, and 60 months after enrollment
Cost-effectiveness analysis of the diagnostic and treatment strategies.
12, 24, and 60 months after enrollment
All-cause Death and Cardiac Death
時間枠：12, 24, and 60 months after enrollment
The rate of death from any cause and death from cardiac causes specifically.
12, 24, and 60 months after enrollment
Non-fatal Myocardial Infarction Including Periprocedural MI
時間枠：12, 24, and 60 months after enrollment
The occurrence of non-fatal myocardial infarction (including both target vessel-related and all-cause events), inclusive of periprocedural myocardial infarction.
12, 24, and 60 months after enrollment
Non-fatal Myocardial Infarction Excluding Periprocedural MI
時間枠：12, 24, and 60 months after enrollment
The occurrence of non-fatal myocardial infarction (including both target vessel-related and all-cause events), excluding periprocedural myocardial infarction.
12, 24, and 60 months after enrollment
Revascularization
時間枠：12, 24, and 60 months after enrollment
The occurrence of any target vessel/lesion revascularization, any non-target vessel/lesion revascularization, and any revascularization (whether ischemia-driven or all-cause)
12, 24, and 60 months after enrollment
Target Vessel or Target Lesion Revascularization
時間枠：12, 24, and 60 months after enrollment
The occurrence of any revascularization procedure involving the target vessel (TVR) or target lesion (TLR).
12, 24, and 60 months after enrollment
Non-Target Vessel or Non-Target Lesion Revascularization
時間枠：12, 24, and 60 months after enrollment
The occurrence of any revascularization procedure involving a non-target vessel (non-TVR) or non-target lesion (non-TLR).
12, 24, and 60 months after enrollment
Stroke
時間枠：12, 24, and 60 months after enrollment
The occurrence of non-fatal stroke, including both ischemic and hemorrhagic types.
12, 24, and 60 months after enrollment
CT Plaque Characteristics and Clinical Associations
時間枠：Baseline, 12, 24, and 60 months after enrollment
The association between CT plaque characteristics, clinical features, and outcomes.
Baseline, 12, 24, and 60 months after enrollment
Correlation of Non-invasive and Invasive Indices
時間枠：Baseline
The correlation of CCTA and CT-derived functional indices (such as CT-IMR) with invasive anatomical and functional indices.
Baseline
Subgroup Analysis of Imaging Features and Clinical Outcomes
時間枠：12, 24, and 60 months after enrollment
The association of specific patient factors-gender differences, diabetes status, and age-with imaging features and clinical outcomes.
12, 24, and 60 months after enrollment

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Second Affiliated Hospital, Zhejiang University, School of Medicine

捜査官

  • 主任研究者：Jun Jiang, MD、Second Affiliated Hospital, Zhejiang University, School of Medicine

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年9月23日

一次修了 (推定)

2030年5月31日

研究の完了 (推定)

2034年5月31日

試験登録日

最初に提出

2026年6月16日

QC基準を満たした最初の提出物

2026年6月16日

最初の投稿 (実際)

2026年6月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月12日

QC基準を満たした最後の更新が送信されました

2026年8月9日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 2026-0520

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いいえ

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