Coronary Artery CalcificationNCT05451368
Neointimal Features in Patients With Restenosis of Calcified Lesions
An observational study of Coronary Artery Calcification and Restenosis, run by Shenyang Northern Hospital at 1 site in China.
Trial summary
Previous studies have suggested that restenosis (RS) after stenting is mainly due to smooth muscle cell proliferation and migration, but recent evidence suggests that in-stent restenosis（ISR） is associated with a number of factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Calcification, Restenosis, Neointima
- What is being tested?
- Coronary artery calcification lesions
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2022to 31 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who had previously undergone stenting in our department were first found to have restenosis due to symptomatic admission angiography, and patients with restenosis were divided into calcified and non-calcified groups according to their first coronary angiography images by OCT.
Who may be able to join
- The patient is older than 18 years.
- The patient had undergone coronary angiography at our hospital for PCI and had first ISR with drug-eluting stent implantation.
- Calcified lesion greater than 5 mm in length.
- Stent implantation time greater than 30 days.
Who cannot join
- Bridge vessel lesions following coronary artery bypass grafting.
- Planned modification of the DAPT regimen for medical reasons or other surgical procedures requiring modification within 3 months of the index procedure.
- Patients undergoing heart transplantation.
- Significant angiogenic lesions in the target vessel that may prevent stent delivery and deployment.
- Bifurcation disease lesions involving collateral branches ≥ 2.5 mm in diameter.
- Lesions deemed by the investigator to be unsuitable for OCT imaging (e.g., extremely curved, very distal lesions).
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- Serum creatinine > 2.0 mg/dl at the time of treatment.
- Greater than three types of stent implantation.
- Subjects with malignancy or other co-morbidities (i.e., severe liver, kidney, lung, or pancreatic disease with a life expectancy of less than 18 months or which may result in protocol non-compliance).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ShenyangNH
Shenyang, Liaoning, 110000
Zhen Fang, 15804084542, plz333333@163.com
About this study
Official title: Characteristics of Intimal and Neoatherosclerosis in Patients With Restenosis After DES Implantation for Calcified Lesions
Previous studies have suggested that restenosis (RS) after stenting is mainly due to smooth muscle cell proliferation and migration, but recent evidence suggests that in-stent restenosis（ISR） is associated with a number of factors. Coronary artery calcification is an independent predictor of ischaemia-mediated revascularisation 1 year after percutaneous coronary intervention (PCI) following RS.The characteristics of new neointima in patients with in-stent restenosis of calcified lesions are important issues to explore
Read the detailed description
The characteristics of the endothelium after DES following implantation of calcified lesions have always been of interest to us. Its inherent peculiarities make the new endothelium of calcified lesions different.
Firstly, the presence of calcification makes the neointima heal slowly. In addition DES has an anti-proliferative effect, which further diminishes the healing ability of the neointima of calcified lesions and impairs the barrier function of the endothelium. This may have a similar pathway to the formation of neointimal atherosclerosis or heterogeneous endothelium within the neointima.
Secondly, stents with calcified lesions can be accompanied by incomplete stent expansion, stent fracture and stent misalignment. These conditions may accelerate the occurrence of restenosis within the stent.
Thirdly, there are different types of calcified lesions. Different types of calcified lesions may heal and restenosis in different ways.
It is therefore understood that calcified lesion healing has a number of pathways that exist in contradiction. These are issues that need to be explored in depth.
- Being tested
- Coronary artery calcification lesions
- Keywords
- coronary artery calcification, ISR, neoatherosclerosis
- Medical subject headings
- Neointima
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary artery calcification lesionsOther
Calcification of atherosclerosis, a complex, organic, regulated and active process, is one of the manifestations of atherosclerosis. The progression of coronary atherosclerosis is a strong independent predictor of future coronary events. It has been shown that coronary artery calcification affects the healing of the neointima and the function of the endothelium after stenting. This may lead to changes in neointimal morphology and the development of neoatherosclerosis after stent implantation.
| Study group | Role | What they receive |
|---|---|---|
| calcified group | A calcified coronary culprit lesion was defined as "readily apparent densities noted within the apparent vascular wall at the site of the stenosis". target lesions were classified as severe ("radio opacities noted without cardiac motion prior to contrast injection generally involving both sides of the arterial wall"),moderate ("densities noted only during the cardiac cycle prior to contrast injection").Severe and moderate calcification is classified as a calcified group. Receives: Other: Coronary artery calcification lesions | |
| non-calcified group | none/mild(lesions other than severe and moderate calcified lesions). none/mild calcification is classified as a non-calcified group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean lumen area
Quantitative Indicators，the mean area bounded by the luminal border on OCT（Optical Coherence Tomography）
Measured: through study completion, an average of 1 year
Minimum lumen area
Quantitative Indicators，the minimum area bounded by the luminal border on OCT
Measured: through study completion, an average of 1 year
Maximum lumen area
Quantitative Indicators，the maximum area bounded by the luminal border on OCT
Measured: through study completion, an average of 1 year
Percent area stenosis
Quantitative Indicators，the (reference lumen area minus the minimum lumen area) divided by the reference lumen area, multiplied by 100. The reference segment used should be specified (proximal, distal, largest or average) on OCT
Measured: through study completion, an average of 1 year
Mean stent area
Quantitative Indicators，the mean area bounded by the stent border on OCT
Measured: through study completion, an average of 1 year
Minimum stent area
Quantitative Indicators，the Minimum area bounded by the stent border on OCT
Measured: through study completion, an average of 1 year
Maximum stent area
Quantitative Indicators，the Maximum area bounded by the stent border on OCT
Measured: through study completion, an average of 1 year
lipid-laden intima
Qualitative indicators,a diffusely bordered, signal-poor region with overlying signal-rich bands in the intima on OCT.the investigators measured its incidence on OCT.
Measured: through study completion, an average of 1 year
Calcification
Qualitative indicators,shows a well-delineated, signal-poor region with sharp borders.the investigators measured its incidence on OCT.
Measured: through study completion, an average of 1 year
Thrombi
Qualitative indicators,masses protruding into the lumen and discontinuous from the surface of the vessel wall.the investigators measured its incidence on OCT.
Measured: through study completion, an average of 1 year
Intimal rupture
Qualitative indicators,discontinuity of the fibrous cap connecting the lumen.the investigators measured its incidence on OCT.
Measured: through study completion, an average of 1 year
Neovascularization
Qualitative indicators,the presence of signal-poor holes or tubular structures with a diameter of 50 to 300 μm that are not connected to the vessel lumen.the investigators measured its incidence on OCT.
Measured: through study completion, an average of 1 year
Thin-cap fibroatheroma (TCFA)
containing intima was defined as fibrous cap thickness ≤65 μm at the thinnest segment and an angle of lipid tissue ≥180°.the investigators measured its incidence on OCT.
Measured: through study completion, an average of 1 year
Macrophage infiltration
Qualitative indicators,a bright spot with a high signal variance from the surrounding tissue.the investigators measured its incidence on OCT.
Measured: through study completion, an average of 1 year
Stent underexpansion
Qualitative indicators,Stent expansion describes the minimum stent cross-sectional area either as an absolute measure (absolute expansion), or compared with the predefined reference area, which can be the proximal, distal, largest, or average reference area (relative expansion).the investigators measured its incidence on OCT.
Measured: through study completion, an average of 1 year
stent fracture
Qualitative indicators,the interruption of stent continuity.the investigators measured its incidence on OCT.
Measured: through study completion, an average of 1 year
Uncovered struts
the ratio of uncovered-to-total stent struts per section was calculated and expressed as percent on OCT.
Measured: through study completion, an average of 1 year
neoatherosclerosis
neoatherosclerosis were defined by the presence of one or more of the following: lipid laden tissue ，thin-cap fibroatheroma (TCFA)，neointimal calcification，Macrophage infiltration.the investigators measured its incidence .
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start17 Mar 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery CalcificationStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Fang, Shenyang Northern Hospital
- Investigators
- geng wang, M.D., Study chair, The General Hospital of Northern Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451368
- Sponsor's protocol ID
- plz333333
- Status last verified
- Jul 2022
- First submitted
- 21 Jun 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The provision of individual patient data requires the informed consent of the patient. In addition, basic information about the patient and coronary angiography results may be provided in the form of pictures or videos. OCT results need to be analyzed in specialized offline software, and the investigators provide the most intuitive OCT results possible.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Intimal and Neoatherosclerosis in Patients With Restenosis After DES Implantation for Calcified Lesions
- ClinicalTrials.gov ID
- NCT05451368
- Acronym / sponsor ID
- plz333333
- Keywords
- coronary artery calcification, ISR, neoatherosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 11 Jul 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.
Previous studies have suggested that restenosis (RS) after stenting is mainly due to smooth muscle cell proliferation and migration, but recent evidence suggests that in-stent restenosis（ISR） is associated with a number of factors. Coronary artery calcification is an independent predictor of ischaemia-mediated revascularisation 1 year after percutaneous coronary intervention (PCI) following RS.The characteristics of new neointima in patients with in-stent restenosis of calcified lesions are important issues to explore
Detailed description
The characteristics of the endothelium after DES following implantation of calcified lesions have always been of interest to us. Its inherent peculiarities make the new endothelium of calcified lesions different.
Firstly, the presence of calcification makes the neointima heal slowly. In addition DES has an anti-proliferative effect, which further diminishes the healing ability of the neointima of calcified lesions and impairs the barrier function of the endothelium. This may have a similar pathway to the formation of neointimal atherosclerosis or heterogeneous endothelium within the neointima.
Secondly, stents with calcified lesions can be accompanied by incomplete stent expansion, stent fracture and stent misalignment. These conditions may accelerate the occurrence of restenosis within the stent.
Thirdly, there are different types of calcified lesions. Different types of calcified lesions may heal and restenosis in different ways.
It is therefore understood that calcified lesion healing has a number of pathways that exist in contradiction. These are issues that need to be explored in depth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcified group | – | Other: Coronary artery calcification lesionsA calcified coronary culprit lesion was defined as "readily apparent densities noted within the apparent vascular wall at the site of the stenosis". target lesions were classified as severe ("radio opacities noted without cardiac motion prior to contrast injection generally involving both sides of the arterial wall"),moderate ("densities noted only during the cardiac cycle prior to contrast injection").Severe and moderate calcification is classified as a calcified group. |
| non-calcified group | – | –none/mild(lesions other than severe and moderate calcified lesions). none/mild calcification is classified as a non-calcified group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who had previously undergone stenting in our department were first found to have restenosis due to symptomatic admission angiography, and patients with restenosis were divided into calcified and non-calcified groups according to their first coronary angiography images by OCT.
Key inclusion criteria (4 listed)
- The patient is older than 18 years.
- The patient had undergone coronary angiography at our hospital for PCI and had first ISR with drug-eluting stent implantation.
- Calcified lesion greater than 5 mm in length.
- Stent implantation time greater than 30 days.
Key exclusion criteria (9 listed)
- Bridge vessel lesions following coronary artery bypass grafting.
- Planned modification of the DAPT regimen for medical reasons or other surgical procedures requiring modification within 3 months of the index procedure.
- Patients undergoing heart transplantation.
- Significant angiogenic lesions in the target vessel that may prevent stent delivery and deployment.
- Bifurcation disease lesions involving collateral branches ≥ 2.5 mm in diameter.
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 |
|---|---|---|
| Coronary artery calcification lesionsCalcification of atherosclerosis, a complex, organic, regulated and active process, is one of the manifestations of atherosclerosis. The progression of coronary atherosclerosis is a strong independent predictor of future coronary events. It has been shown that coronary artery calcification affects the healing of the neointima and the function of the endothelium after stenting. This may lead to changes in neointimal morphology and the development of neoatherosclerosis after stent implantation. | Other | calcified group |
Primary outcome
Mean lumen area
Time frame: through study completion, an average of 1 year
Quantitative Indicators，the mean area bounded by the luminal border on OCT（Optical Coherence Tomography）
Minimum lumen area
Time frame: through study completion, an average of 1 year
Quantitative Indicators，the minimum area bounded by the luminal border on OCT
Maximum lumen area
Time frame: through study completion, an average of 1 year
Quantitative Indicators，the maximum area bounded by the luminal border on OCT
Percent area stenosis
Time frame: through study completion, an average of 1 year
Quantitative Indicators，the (reference lumen area minus the minimum lumen area) divided by the reference lumen area, multiplied by 100. The reference segment used should be specified (proximal, distal, largest or average) on OCT
Mean stent area
Time frame: through study completion, an average of 1 year
Quantitative Indicators，the mean area bounded by the stent border on OCT
Minimum stent area
Time frame: through study completion, an average of 1 year
Quantitative Indicators，the Minimum area bounded by the stent border on OCT
Maximum stent area
Time frame: through study completion, an average of 1 year
Quantitative Indicators，the Maximum area bounded by the stent border on OCT
lipid-laden intima
Time frame: through study completion, an average of 1 year
Qualitative indicators,a diffusely bordered, signal-poor region with overlying signal-rich bands in the intima on OCT.the investigators measured its incidence on OCT.
Calcification
Time frame: through study completion, an average of 1 year
Qualitative indicators,shows a well-delineated, signal-poor region with sharp borders.the investigators measured its incidence on OCT.
Thrombi
Time frame: through study completion, an average of 1 year
Qualitative indicators,masses protruding into the lumen and discontinuous from the surface of the vessel wall.the investigators measured its incidence on OCT.
Intimal rupture
Time frame: through study completion, an average of 1 year
Qualitative indicators,discontinuity of the fibrous cap connecting the lumen.the investigators measured its incidence on OCT.
Neovascularization
Time frame: through study completion, an average of 1 year
Qualitative indicators,the presence of signal-poor holes or tubular structures with a diameter of 50 to 300 μm that are not connected to the vessel lumen.the investigators measured its incidence on OCT.
Thin-cap fibroatheroma (TCFA)
Time frame: through study completion, an average of 1 year
containing intima was defined as fibrous cap thickness ≤65 μm at the thinnest segment and an angle of lipid tissue ≥180°.the investigators measured its incidence on OCT.
Macrophage infiltration
Time frame: through study completion, an average of 1 year
Qualitative indicators,a bright spot with a high signal variance from the surrounding tissue.the investigators measured its incidence on OCT.
Stent underexpansion
Time frame: through study completion, an average of 1 year
Qualitative indicators,Stent expansion describes the minimum stent cross-sectional area either as an absolute measure (absolute expansion), or compared with the predefined reference area, which can be the proximal, distal, largest, or average reference area (relative expansion).the investigators measured its incidence on OCT.
stent fracture
Time frame: through study completion, an average of 1 year
Qualitative indicators,the interruption of stent continuity.the investigators measured its incidence on OCT.
Uncovered struts
Time frame: through study completion, an average of 1 year
the ratio of uncovered-to-total stent struts per section was calculated and expressed as percent on OCT.
neoatherosclerosis
Time frame: through study completion, an average of 1 year
neoatherosclerosis were defined by the presence of one or more of the following: lipid laden tissue ，thin-cap fibroatheroma (TCFA)，neointimal calcification，Macrophage infiltration.the investigators measured its incidence .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: Undecided. The provision of individual patient data requires the informed consent of the patient. In addition, basic information about the patient and coronary angiography results may be provided in the form of pictures or videos. OCT results need to be analyzed in specialized offline software, and the investigators provide the most intuitive OCT results possible.
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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.
geng wang, M.D. study chair
The General Hospital of Northern Theater Command
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 Calcification and Restenosis, run by Shenyang Northern 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 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: status not confirmed, as of the sponsor's last update on 19 Jul 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 geng wang, M.D. (13309886393, wanggeng69@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean lumen area (time frame: through study completion, an average of 1 year). The study lists 18 primary outcomes in all. 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 19 Jul 2022.