Coronary; IschemicNCT04664439
Follow-up With CT-FFR in CHD Patients After DCB
A study testing CT-FFR in people with Coronary; Ischemic, run by Beijing Hospital at 1 site in China.
Trial summary
In recent years, based on CCTA data, CT-derived fractional flow reserve (CT-FFR) developed by artificial intelligence and other technologies can provide both anatomical and functional information of coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary; Ischemic
- What is being tested?
- CT-FFR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to understand the purpose of the test and sign the informed consent form.
- 6-12 months after DCB for coronary heart disease, there is no contraindication of coronary artery CTA examination.
- Non-target lesions of unplanned revascularization within 6 months.
- According to the clinical manifestations and auxiliary examinations (such as EET, SPECT, CCTA), the attending doctor will make a comprehensive judgment on the patients who plan to undergo ICA.
Who cannot join
- Patient exclusion criteria:
- Previous coronary artery bypass (CABG) surgery, coronary artery stent implantation, artificial heart valve implantation, cardiac pacemaker or implantable defibrillator implantation.
- Persistent or active symptoms of clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure (systolic blood pressure less than 90 mmHg), severe congestive heart failure (NYHA heart function III or IV) or acute pulmonary edema.
- Acute myocardial infarction occurred within 7 days before selection.
- Patients with other severe diseases are not suitable to participate in clinical trials, such as history of complex congenital heart disease, sick sinus syndrome, long QT syndrome, severe arrhythmia or tachycardia, severe asthma, severe or extremely severe chronic obstructive pulmonary disease, chronic renal dysfunction (serum creatinine level > 2.0mg / dl or creatinine clearance < 30ml/ Kg ·1.73m2).
- Allergic to iodinated contrast medium.
Show all 19Show fewer
- Other serious allergic diseases such as allergic asthma.
- Pregnancy or pregnancy status unknown.
- Life expectancy is less than 6 months.
- There are any factors that other researchers think are not suitable for selection or completion of this study.
- -
- CCTA image exclusion criteria:
- Obvious dislocation of coronary artery image.
- CCTA images indicate that the reference vessel diameter of the stenotic segment is less than 2.0mm.
- The image of coronary artery calcification accounting for more than 80% of the cross-sectional area of the lumen.
- The standard deviation of CT value (SD value) of aortic root image was higher than that of 30HU.
- Coronary artery occlusion.
- The CT-FFR measurement can not be completed due to the quality problem of the image file.
- The clinical trial could not be completed and no effective data were obtained due to other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital
Beijing
Xin Wang, Dr, 00861058115037, bjyygcp@126.com
About this study
Official title: Application of CT-derived Fractional Flow Reserve in Patients With Coronary Heart Disease After Drug-coated Balloon Intervention
In recent years, based on CCTA data, CT-derived fractional flow reserve (CT-FFR) developed by artificial intelligence and other technologies can provide both anatomical and functional information of coronary artery disease. Compared with CCTA alone, CT-FFR has a better ability to diagnose coronary ischemic lesions and can effectively reduce the need for unnecessary ICA, to predict revascularization more accurately.
Read the detailed description
Drug-coated balloon (DCB) intervention is a non-drug treatment of coronary heart disease with the advantage of "no implantation". In recent years, it is more and more used in primary coronary artery disease. Timely detection of restenosis after DCB is very important to ensure the safety of patients. Invasive coronary angiography (ICA) is the "gold standard" to reflect coronary artery stenosis, but it is difficult to become a routine follow-up tool for surgical trauma, radiation exposure and other reasons, let alone for elderly patients.
Coronary artery computed tomography angiography (CCTA) can provide a variety of anatomical information such as the degree of coronary artery stenosis and the nature of plaques. It is a commonly used tool for non-invasive imaging diagnosis of coronary heart disease. However, because of its low diagnostic specificity and can not reflect the lesion-related myocardial ischemia, the positive rate of coronary heart disease and the rate of revascularization in patients undergoing ICA are low. In recent years, based on CCTA data, CT-derived fractional flow reserve (CT-FFR) developed by artificial intelligence and other technologies can provide both anatomical and functional information of coronary artery disease. A number of studies have shown that, compared with CCTA alone, CT-FFR has a better ability to diagnose coronary ischemic lesions and can effectively reduce the need for unnecessary ICA, to predict revascularization more accurately. Due to the absence of metal foreign body implantation, DCB intervention makes it possible for CT-FFR to be used in imaging evaluation after DCB. At present, there is no study on the use of CT-FFR in patients after DCB.
In this study, the self-developed CT-FFR based on artificial intelligence was used for the first time to analyze coronary artery lesions in patients after DCB, and to compare the guiding value of CT-FFR and simple CCTA in ICA and revascularization, in order to provide an ideal non-invasive imaging follow-up tool for elderly patients after DCB.
- Conditions
- Coronary; Ischemic
- Being tested
- CT-FFR
- Keywords
- CT-derived fractional flow reserve, drug-coated balloon
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-FFRDiagnostic test
CCTA examination will be performed by qualified medical imaging technicians, and patients will be scanned with 256rows of CT, according to standard operating norms. The coronary artery physiological function evaluation software(Keya Medical Technology, Beijing, China)will be configured in the core laboratory in advance, and the relevant imaging analysts will be trained. The core laboratory will receive the CCTA inspection data and evaluate the CCTA image quality. According to the standard operation flow of the software specification, the CT-FFR analysis will be carried out on the images that meet the requirements, and the CT-FFR value of the lesions will be measured.
| Study group | Role | What they receive |
|---|---|---|
| CT-FFR | Experimental | The CCTA images of the patients in this group will be analyzed and the FFR values of the lesions will be measured using the indicated software. ICA will be determined according to the value of CTFFR. Receives: Diagnostic Test: CT-FFR |
| direct ICA | No intervention | The patients will be submitted to undergoing ICA procedure according to the decision of the investigators. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of non-obstructive coronary heart disease in ICA examination
Proportion of non-obstructive coronary heart disease in ICA examination
Measured: Clinical follow-up at 6 months after ICA or CT-FFR
Secondary outcomes (1)
The rate of major adverse cardiac events (MACEs)
A composite endpoint of MACEs, including revascularization, non-fatal myocardial infarction, death and readmission for chest pain
Measured: Clinical follow-up at 6 months after ICA or CT-FFR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Jun 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary; IschemicStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
- Responsible party
- Principal investigator, Xue Yu, Beijing Hospital
- Investigators
- Xue Yu, MD, Study chair, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664439
- Sponsor's protocol ID
- CT-FFR after DCB
- Status last verified
- Feb 2023
- First submitted
- 6 Dec 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of CT-derived Fractional Flow Reserve in Patients With Coronary Heart Disease After Drug-coated Balloon Intervention
- ClinicalTrials.gov ID
- NCT04664439
- Acronym / sponsor ID
- CT-FFR after DCB
- Conditions
- Coronary; Ischemic
- Keywords
- CT-derived fractional flow reserve, drug-coated balloon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Beijing HospitalOther government
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 11 Dec 2020 (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.
In recent years, based on CCTA data, CT-derived fractional flow reserve (CT-FFR) developed by artificial intelligence and other technologies can provide both anatomical and functional information of coronary artery disease. Compared with CCTA alone, CT-FFR has a better ability to diagnose coronary ischemic lesions and can effectively reduce the need for unnecessary ICA, to predict revascularization more accurately.
Detailed description
Drug-coated balloon (DCB) intervention is a non-drug treatment of coronary heart disease with the advantage of "no implantation". In recent years, it is more and more used in primary coronary artery disease. Timely detection of restenosis after DCB is very important to ensure the safety of patients. Invasive coronary angiography (ICA) is the "gold standard" to reflect coronary artery stenosis, but it is difficult to become a routine follow-up tool for surgical trauma, radiation exposure and other reasons, let alone for elderly patients.
Coronary artery computed tomography angiography (CCTA) can provide a variety of anatomical information such as the degree of coronary artery stenosis and the nature of plaques. It is a commonly used tool for non-invasive imaging diagnosis of coronary heart disease. However, because of its low diagnostic specificity and can not reflect the lesion-related myocardial ischemia, the positive rate of coronary heart disease and the rate of revascularization in patients undergoing ICA are low. In recent years, based on CCTA data, CT-derived fractional flow reserve (CT-FFR) developed by artificial intelligence and other technologies can provide both anatomical and functional information of coronary artery disease. A number of studies have shown that, compared with CCTA alone, CT-FFR has a better ability to diagnose coronary ischemic lesions and can effectively reduce the need for unnecessary ICA, to predict revascularization more accurately. Due to the absence of metal foreign body implantation, DCB intervention makes it possible for CT-FFR to be used in imaging evaluation after DCB. At present, there is no study on the use of CT-FFR in patients after DCB.
In this study, the self-developed CT-FFR based on artificial intelligence was used for the first time to analyze coronary artery lesions in patients after DCB, and to compare the guiding value of CT-FFR and simple CCTA in ICA and revascularization, in order to provide an ideal non-invasive imaging follow-up tool for elderly patients after DCB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-FFR | Experimental | Diagnostic Test: CT-FFRThe CCTA images of the patients in this group will be analyzed and the FFR values of the lesions will be measured using the indicated software. ICA will be determined according to the value of CTFFR. |
| direct ICA | No intervention | –The patients will be submitted to undergoing ICA procedure according to the decision of the investigators. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be able to understand the purpose of the test and sign the informed consent form.
- 6-12 months after DCB for coronary heart disease, there is no contraindication of coronary artery CTA examination.
- Non-target lesions of unplanned revascularization within 6 months.
- According to the clinical manifestations and auxiliary examinations (such as EET, SPECT, CCTA), the attending doctor will make a comprehensive judgment on the patients who plan to undergo ICA.
Key exclusion criteria (19 listed)
- Previous coronary artery bypass (CABG) surgery, coronary artery stent implantation, artificial heart valve implantation, cardiac pacemaker or implantable defibrillator implantation.
- Persistent or active symptoms of clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure (systolic blood pressure less than 90 mmHg), severe congestive heart failure (NYHA heart function III or IV) or acute pulmonary edema.
- Acute myocardial infarction occurred within 7 days before selection.
- Patients with other severe diseases are not suitable to participate in clinical trials, such as history of complex congenital heart disease, sick sinus syndrome, long QT syndrome, severe arrhythmia or tachycardia, severe asthma, severe or extremely severe chronic obstructive pulmonary disease, chronic renal dysfunction (serum creatinine level > 2.0mg / dl or creatinine clearance < 30ml/ Kg ·1.73m2).
- Allergic to iodinated contrast medium.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-FFRCCTA examination will be performed by qualified medical imaging technicians, and patients will be scanned with 256rows of CT, according to standard operating norms. The coronary artery physiological function evaluation software(Keya Medical Technology, Beijing, China)will be configured in the core laboratory in advance, and the relevant imaging analysts will be trained. The core laboratory will receive the CCTA inspection data and evaluate the CCTA image quality. According to the standard operation flow of the software specification, the CT-FFR analysis will be carried out on the images that meet the requirements, and the CT-FFR value of the lesions will be measured. | Diagnostic test | CT-FFR |
Primary outcome
Proportion of non-obstructive coronary heart disease in ICA examination
Time frame: Clinical follow-up at 6 months after ICA or CT-FFR
Proportion of non-obstructive coronary heart disease in ICA examination
1 secondary outcome
The rate of major adverse cardiac events (MACEs)
Time frame: Clinical follow-up at 6 months after ICA or CT-FFR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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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. This study is not recruiting at the moment.
Xue Yu, MD study chair
Beijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-FFR in people with Coronary; Ischemic, run by Beijing Hospital 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 19 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xue Yu, MD (00861085132266 ext. 2535, yuxuemd@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of non-obstructive coronary heart disease in ICA examination (time frame: Clinical follow-up at 6 months after ICA or CT-FFR). 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 8 Feb 2023.