Neointimal Features in Patients With Restenosis of Calcified Lesions

NCT05451368 | Unknown

• 1 other identifier: plz333333
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Coronary Artery Calcification; Restenosis; Neointima; Neoatherosclerosis

Keywords

coronary artery calcification; ISR; neoatherosclerosis

Outcome Measures

Primary Outcomes (18)

• Mean lumen area

  Quantitative Indicators，the mean area bounded by the luminal border on OCT（Optical Coherence Tomography）

  through study completion, an average of 1 year

• Minimum lumen area

  Quantitative Indicators，the minimum area bounded by the luminal border on OCT

  through study completion, an average of 1 year

• Maximum lumen area

  Quantitative Indicators，the maximum area bounded by the luminal border on OCT

  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

  through study completion, an average of 1 year

• Mean stent area

  Quantitative Indicators，the mean area bounded by the stent border on OCT

  through study completion, an average of 1 year

• Minimum stent area

  Quantitative Indicators，the Minimum area bounded by the stent border on OCT

  through study completion, an average of 1 year

• Maximum stent area

  Quantitative Indicators，the Maximum area bounded by the stent border on OCT

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  through study completion, an average of 1 year

• stent fracture

  Qualitative indicators,the interruption of stent continuity.the investigators measured its incidence on OCT.

  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.

  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 .

  through study completion, an average of 1 year

Study Arms (2)

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.

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.

Interventions

Coronary artery calcification lesions OTHER

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.

calcified group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• Shenyang Northern Hospital: lead

Study Sites (1)

ShenyangNH

Shenyang, Liaoning, 110000, China

RECRUITING

MeSH Terms

Conditions

Neointima

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• geng wang, M.D.

  The General Hospital of Northern Theater Command

  STUDY CHAIR

Central Study Contacts

geng wang, M.D.

CONTACT

13309886393; wanggeng69@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical doctor

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 11, 2022
• Study Start: March 17, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 31, 2023
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

CN (1)