Coronary Artery DiseaseACCURATE-PRONCT07659119
Assessment of CT-FFR in Patients With CCS: A Prospective Multicenter Cohort Study
An observational study of Coronary Artery Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2024to 31 May 2034
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: 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.
Read more
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.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Composite of All-cause Death, Myocardial Infarction (MI), or Ischemia-driven Revascularization
The primary endpoint is defined as the composite occurrence of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization.
Measured: 12 months after enrollment
Secondary outcomes (15)
Primary Endpoint Excluding Periprocedural MI
The primary composite endpoint of all-cause death, myocardial infarction, or ischemia-driven revascularization, excluding periprocedural myocardial infarction.
Measured: 12 months after enrollment
Composite of All-cause Death, Myocardial Infarction (MI), or Ischemia-driven Revascularization
The primary endpoint is defined as the composite occurrence of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization.
Measured: 24 and 60 months after enrollment
Individual Components of the Primary Endpoint
The occurrence of the individual components of the primary composite endpoint, analyzed separately. These include all-cause death, myocardial infarction, and ischemia-driven revascularization.
Measured: 12 months after enrollment
Target Vessel Failure (TVF)
A composite endpoint including cardiac death, target vessel myocardial infarction (MI), or target vessel revascularization.
Measured: 12, 24, and 60 months after enrollment
Health Economics Analysis
Cost-effectiveness analysis of the diagnostic and treatment strategies.
Measured: 12, 24, and 60 months after enrollment
All-cause Death and Cardiac Death
The rate of death from any cause and death from cardiac causes specifically.
Measured: 12, 24, and 60 months after enrollment
Non-fatal Myocardial Infarction Including Periprocedural MI
The occurrence of non-fatal myocardial infarction (including both target vessel-related and all-cause events), inclusive of periprocedural myocardial infarction.
Measured: 12, 24, and 60 months after enrollment
Non-fatal Myocardial Infarction Excluding Periprocedural MI
The occurrence of non-fatal myocardial infarction (including both target vessel-related and all-cause events), excluding periprocedural myocardial infarction.
Measured: 12, 24, and 60 months after enrollment
Revascularization
The occurrence of any target vessel/lesion revascularization, any non-target vessel/lesion revascularization, and any revascularization (whether ischemia-driven or all-cause)
Measured: 12, 24, and 60 months after enrollment
Target Vessel or Target Lesion Revascularization
The occurrence of any revascularization procedure involving the target vessel (TVR) or target lesion (TLR).
Measured: 12, 24, and 60 months after enrollment
Non-Target Vessel or Non-Target Lesion Revascularization
The occurrence of any revascularization procedure involving a non-target vessel (non-TVR) or non-target lesion (non-TLR).
Measured: 12, 24, and 60 months after enrollment
Stroke
The occurrence of non-fatal stroke, including both ischemic and hemorrhagic types.
Measured: 12, 24, and 60 months after enrollment
CT Plaque Characteristics and Clinical Associations
The association between CT plaque characteristics, clinical features, and outcomes.
Measured: Baseline, 12, 24, and 60 months after enrollment
Correlation of Non-invasive and Invasive Indices
The correlation of CCTA and CT-derived functional indices (such as CT-IMR) with invasive anatomical and functional indices.
Measured: Baseline
Subgroup Analysis of Imaging Features and Clinical Outcomes
The association of specific patient factors-gender differences, diabetes status, and age-with imaging features and clinical outcomes.
Measured: 12, 24, and 60 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start23 Sep 2024
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Jiang, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659119
- Sponsor's protocol ID
- 2026-0520
- Acronym
- ACCURATE-PRO
- Status last verified
- May 2026
- First submitted
- 16 Jun 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Coronary Computed Tomography-Derived Fractional Flow Reserve in Patients With Chronic Coronary Syndrome: A Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07659119
- Acronym / sponsor ID
- ACCURATE-PRO / 2026-0520
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2034 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
15 secondary outcomes
Primary Endpoint Excluding Periprocedural MI
Time frame: 12 months after enrollment
Composite of All-cause Death, Myocardial Infarction (MI), or Ischemia-driven Revascularization
Time frame: 24 and 60 months after enrollment
Individual Components of the Primary Endpoint
Time frame: 12 months after enrollment
Target Vessel Failure (TVF)
Time frame: 12, 24, and 60 months after enrollment
Health Economics Analysis
Time frame: 12, 24, and 60 months after enrollment
All-cause Death and Cardiac Death
Time frame: 12, 24, and 60 months after enrollment
Non-fatal Myocardial Infarction Including Periprocedural MI
Time frame: 12, 24, and 60 months after enrollment
Non-fatal Myocardial Infarction Excluding Periprocedural MI
Time frame: 12, 24, and 60 months after enrollment
Revascularization
Time frame: 12, 24, and 60 months after enrollment
Target Vessel or Target Lesion Revascularization
Time frame: 12, 24, and 60 months after enrollment
Non-Target Vessel or Non-Target Lesion Revascularization
Time frame: 12, 24, and 60 months after enrollment
Stroke
Time frame: 12, 24, and 60 months after enrollment
CT Plaque Characteristics and Clinical Associations
Time frame: Baseline, 12, 24, and 60 months after enrollment
Correlation of Non-invasive and Invasive Indices
Time frame: Baseline
Subgroup Analysis of Imaging Features and Clinical Outcomes
Time frame: 12, 24, and 60 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Jiang, MD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Jiang, MD (+(86) 13588706891, jiang-jun@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of All-cause Death, Myocardial Infarction (MI), or Ischemia-driven Revascularization (time frame: 12 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.