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

June 16, 2026 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite of All-cause Death, Myocardial Infarction (MI), or Ischemia-driven Revascularization
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Primary Endpoint Excluding Periprocedural MI
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jun Jiang, MD, Second Affiliated Hospital, School of Medicine, Zhejiang University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2034

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-0520

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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