AtherosclerosisNCT04416425
Hemodynamic Change of Coronary Atherosclerotic Plaque After Evolocumab Treatment
An observational study of Atherosclerosis, run by Zibo Central Hospital at 1 site in China.
Trial summary
Compelling evidences indicate that lipid-lowering therapy can reduce the high-risk plaque feathers and improve the coronary flow reserve. This study is going to investigate the change of lesion-specific hemodynamic significance as determined by ML(Machine Learning)-based CT-FFR (Computed Tomography-Fractional Flow… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atherosclerosis
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2021to 27 Feb 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 200 eligible coronary atherosclerosis disease patients were anticipated to include in this study.
Who may be able to join
- 1.baseline CCTA revealed at least one lesion with stenotic extent from 50% to 69% on major epicardial arteries (diameter ≧2 mm);
- 2.patients were referred for optimal medical treatment;
- 3.patients agreed to undergo follow-up CCTA at 1-year interval.
Who cannot join
- 1.patients had previous history of myocardial infarction or coronary revascularization;
- 2.patients were contraindicated to the usage of iodine contrast media;
- 3.image quality of baseline or follow-up CCTA was severely impaired (in presence of severe artifact, non-diagnostic);
- 4.patients withdrew the informed consents during follow-up;
- 5.patients experienced major adverse cardiac events during follow-up;
- 6.patients refused to undergo follow-up CCTA;
- 7.lost follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Change of Coronary Atherosclerotic Plaque After Evolocumab Treatment: A Serial Follow-Up Study by Computed Tomography-Derived Fractional Flow Reserve
Compelling evidences indicate that lipid-lowering therapy can reduce the high-risk plaque feathers and improve the coronary flow reserve. This study is going to investigate the change of lesion-specific hemodynamic significance as determined by ML(Machine Learning)-based CT-FFR (Computed Tomography-Fractional Flow Reserve)after Evolocumab treatment.
- Conditions
- Atherosclerosis
- Medical subject headings
- Atherosclerosis
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 |
|---|---|---|
| Enrolled Cohort | 200 selected patients will be recruited, who have diagnosed with coronary atherosclerosis disease(stenotic extent from 50% to 69% on major epicardial arteries) by coronary computed tomography angiography(CCTA). Every two weeks, these patients will be treated with Elococumab Injection (1ml:140mg),ih.This therapy will last for one year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of lesion-specific CT-FFR
After one year's treatment of Elovocumab Injection, the patients will undergo follow-up CCTA again. We will measure the proximal and distal CT-FFR for each lesion.At the same time ,we will calculated the change in CT-FFR value across the lesion(ΔCT-FFR=CT-FFRproximal-CT-FFRdistal).To compare the parameters above,we shall identify whether the treatment of Elovocumab Injection improves the lesion-specific CT-FFR.
Measured: June 2020 to December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start30 Jul 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion27 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zibo Central Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Bo Li, Doctor, Principal investigator, Zibo Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416425
- Sponsor's protocol ID
- ZiboCH
- Status last verified
- May 2020
- First submitted
- 30 May 2020
- Last updated
- 21 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Change of Coronary Atherosclerotic Plaque After Evolocumab Treatment: A Serial Follow-Up Study by Computed Tomography-Derived Fractional Flow Reserve
- ClinicalTrials.gov ID
- NCT04416425
- Acronym / sponsor ID
- ZiboCH
- Conditions
- Atherosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zibo Central HospitalOther government
- Study start
- 30 Jul 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 27 Feb 2023 (estimated)
- First posted
- 4 Jun 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.
Compelling evidences indicate that lipid-lowering therapy can reduce the high-risk plaque feathers and improve the coronary flow reserve. This study is going to investigate the change of lesion-specific hemodynamic significance as determined by ML(Machine Learning)-based CT-FFR (Computed Tomography-Fractional Flow Reserve)after Evolocumab treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled Cohort | – | –200 selected patients will be recruited, who have diagnosed with coronary atherosclerosis disease(stenotic extent from 50% to 69% on major epicardial arteries) by coronary computed tomography angiography(CCTA). Every two weeks, these patients will be treated with Elococumab Injection (1ml:140mg),ih.This therapy will last for one year. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 200 eligible coronary atherosclerosis disease patients were anticipated to include in this study.
Key inclusion criteria (3 listed)
- 1.baseline CCTA revealed at least one lesion with stenotic extent from 50% to 69% on major epicardial arteries (diameter ≧2 mm);
- 2.patients were referred for optimal medical treatment;
- 3.patients agreed to undergo follow-up CCTA at 1-year interval.
Key exclusion criteria (7 listed)
- 1.patients had previous history of myocardial infarction or coronary revascularization;
- 2.patients were contraindicated to the usage of iodine contrast media;
- 3.image quality of baseline or follow-up CCTA was severely impaired (in presence of severe artifact, non-diagnostic);
- 4.patients withdrew the informed consents during follow-up;
- 5.patients experienced major adverse cardiac events during follow-up;
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
the change of lesion-specific CT-FFR
Time frame: June 2020 to December 2021
After one year's treatment of Elovocumab Injection, the patients will undergo follow-up CCTA again. We will measure the proximal and distal CT-FFR for each lesion.At the same time ,we will calculated the change in CT-FFR value across the lesion(ΔCT-FFR=CT-FFRproximal-CT-FFRdistal).To compare the parameters above,we shall identify whether the treatment of Elovocumab Injection improves the lesion-specific CT-FFR.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Bo Li, Doctor principal investigator
Zibo Central Hospital
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 Atherosclerosis, run by Zibo Central 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 3 inclusion and 7 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 21 Apr 2021. 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 Bo Li, Doctor (+86-18560292371, libosubmit@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of lesion-specific CT-FFR (time frame: June 2020 to December 2021). 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 21 Apr 2021.