Coronary AngiographyNCT05319119
Fractional Flow Reserve Derived From CT Related Treatment
An observational study of Coronary Angiography and Fractional Flow Reserve, Myocardial, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Angiography, Fractional Flow Reserve, Myocardial, Coronary Artery Disease
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2022to 29 Apr 2022
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 450000
Chanyu Gao, M.D, 8613937165590, gaocy6802@163.com
About this study
Official title: 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.
Read the 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:
- 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
- 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.
- Keywords
- Fractional Flow Reserve, CT-FFR, prognosis, coronary Revascularization
- 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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
All-cause death or Myocardial infarction
Cardiovascular, non-cardiovascular and undetermined death or Target vessel related and non-target vessel related MI
Measured: 1 year
Secondary outcomes (6)
Heart failure
Heart failure
Measured: 1 year,2 years
Non-target vessel revascularization
The ischemia driven and non-ischemia driven non-target vessel revascularization
Measured: 1 year,2 years
Cardiac death
Cardiovascular death
Measured: 1 year,2 years
Target vessel revascularization
The ischemia driven and non-ischemia driven target vessel revascularization
Measured: 1 year,2 years
Myocardial infarction
Target vessel related and non-target vessel related MI
Measured: 1 year,2 years
Stroke
Stroke
Measured: 1 year,2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start29 Mar 2022
- Primary completion6 Apr 2022 (estimated)
- Study completion29 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AngiographyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuanyu Gao, Henan Institute of Cardiovascular Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319119
- Sponsor's protocol ID
- BHe
- Status last verified
- Mar 2022
- First submitted
- 31 Mar 2022
- Last updated
- 8 Apr 2022
- 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 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Of Revascularization Related By Blood Fractional Flow Reserve Calculated By Coronary Artery CTA On Prognosis
- ClinicalTrials.gov ID
- NCT05319119
- Acronym / sponsor ID
- BHe
- Keywords
- Fractional Flow Reserve, CT-FFR, prognosis, coronary Revascularization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 6 Apr 2022 (estimated)
- Study completion
- 29 Apr 2022 (estimated)
- First posted
- 8 Apr 2022 (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.
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.
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:
- 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
- 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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- ①Diagnosed or suspected coronary heart disease patients during the diagnosis and treatment process
- Patients with CAG (coronary CTA before coronary angiography after CAG, no more than 28 days apart).
- ③Age 18 to 75 years old.
Key exclusion criteria (2 listed)
- ① The presence of severe artifact, dislocation or calcification in coronary CTA images affects FFRCT measurement. ② Contraindications to antiplatelet drugs
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
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
6 secondary outcomes
Heart failure
Time frame: 1 year,2 years
Non-target vessel revascularization
Time frame: 1 year,2 years
Cardiac death
Time frame: 1 year,2 years
Target vessel revascularization
Time frame: 1 year,2 years
Myocardial infarction
Time frame: 1 year,2 years
Stroke
Time frame: 1 year,2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
Related trials for Coronary Angiography
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Randomized Prospective Trial on the Cost-Effectiveness of Photon-Counting CT Versus Energy-Integrating Detector CT in Suspected Chronic Coronary Syndrome
Computed Tomography Angiography, Coronary Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
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.
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 Angiography and Fractional Flow Reserve, Myocardial, run by Henan Institute of Cardiovascular Epidemiology 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 2 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 Apr 2022. 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 Gao, M.D (8613937165590, gaocy6802@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death or Myocardial infarction (time frame: 1 year). 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 Apr 2022.