Optical Coherence Tomography (OCT) Findings and Coronary Bifurcation Lesions

Prevalence of Vulnerable Plaque Its Location and Clinical Significance in Bifurcation Lesions Detected by Optical Coherence Tomography.

To determine the clinical prevalence of vulnerable plaque using OCT in patients with coronary bifurcation lesion.

Study Overview

• Status: Completed
• Conditions: Coronary Bifurcation Lesions
• Intervention / Treatment: Procedure: percutaneous coronary intervention

Detailed Description

This is a prospective registry study in which patient with bifurcation lesion undergoing baseline coronary angiography, baseline OCT and percutaneous coronary intervention will be studied. OCT is used to assess the prevalence of vulnerable plaque, its location at bifurcation lesions and compare vulnerable plaque related major adverse cardiovascular events (MACE) during one-year follow-up in bifurcation lesions between patients with vulnerable plaque and those without. Relationship between endothelial shear stress and vulnerable plaque. Relationship between bifurcation angle and vulnerable plaque.

Group A: presence of vulnerable plaque at the bifurcation Group B: absence of vulnerable plaque at the bifurcation Documentation of immediate post stent OCT and 12 months follow up angiography with OCT will be performed. Immediate post stent OCT to assess successful stent implantation and after 12 months follow up to document year major adverse cardiovascular events (MACE) included myocardial infraction, cardiac death and clinically driven target lesion revascularization, stent thrombosis.

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients ≥ 18 years old
• Patients with ischemic heart disease who are considered for coronary revascularization with PCI
• True coronary bifurcation lesion Medina 1.1.1, 0.1.1, 1.0.1 (stenosis> 50% by visual estimation) treated by drug-eluting stent
• Reference vessel diameter of main vessel >= 2.5mm and side branch >=2.0 mm by visual estimation

Exclusion Criteria:

• Saphenous vein grafts
• In-stent restenotic lesions
• Thombus-containing lesions
• Patient who had Myocardial infarction with in less than one month
• Patent who had bifurcation lesion dilation with balloon
• Contraindication or hypersensitivity to anti-platelet agents or contrast media
• Creatinine level ≥ 2.0 mg/dL
• Severe hepatic dysfunction (3 times normal reference values)
• Hemodynamic unstable patients
• Inability of OCT devise to cross the lesion into distal vessel
• Pregnant women or women with potential childbearing
• Inability to understand or read the informed content

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vulnerable plaque; Thin-cap fibro atheroma (TCFA) was defined as a lipid-rich plaque with the thinnest fibrous cap thickness<65um. Plaque rupture was identified by the presence of fibrous cap discontinuity with a clear cavity formation inside the plaque. Plaque erosion is characterized by luminal thrombus and absence of the endothelium or without evidence of fibrous cap disruption. Fibro calcific plaque contains OCT evidence of fibrous tissue along with calcium that appears as a signal-poor or heterogeneous region with a sharply delineated border which is applied to larger calcifications. Calcified nodule is characterized as a signal or multiple regions of calcium protruding into the lumen, superficial calcification accompanied by substantive calcium proximal and or distal to the lesion. Thrombus is defined as a mass attached to luminal surface or floating within the lumen. It is seen as a protrusion inside the lumen of the artery with signal attenuation.	Procedure: percutaneous coronary intervention; percutaneous coronary intervention with drug-eluting stent implantation.; Other Names: PCI
Active Comparator: Without any vulnerable plaqueStable plaque; patient with bifurcation lesion undergoing baseline coronary angiography and baseline OCT.	Procedure: percutaneous coronary intervention; percutaneous coronary intervention with drug-eluting stent implantation.; Other Names: PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of coronary vulnerable plaques in bifurcation lesions using coherence tomography (OCT)	Vulnerable plaque was considered when presence of Thin-cap fibro atheroma (TCFA), Lipid-rich plaque (vulnerable), Plaque rupture, Plaque erosion, thrombus and calcified nodule.	Documentation of baseline OCT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular Events (MACE)	MACE was included myocardial infarction, cardiac death, and target lesion revascularization.	0 to 12 months
Stent Thrombosis	Stent thrombosis was defined according to the Academic Research Consortium definition.	0 to 12 months
Thin-cap fibroatheroma	Thin-cap fibroatheroma was defined as a lipid-rich plaque with the thinnest fibrous cap thickness < 65 µm.	0 to 12 months
Calcified nodule	Calcified nodule is characterized as a signal or multiple regions of calcium protruding into the lumen, superficial calcification accompanied by substantive calcium proximal and or distal to the lesion.	0 to 12 months
Plaque erosion	Plaque erosion is characterized by luminal thrombus and absence of the endothelium, without evidence of fibrous cap disruption.	0 to 12 months
Plaque rupture	Rupture was identified by the presence of fibrous cap discontinuity with a clear cavity formation inside the plaque.	0 to 12 months
Thrombus	Thrombus is defined as a mass attached to luminal surface or floating within the lumen. It is seen as a protrusion inside the lumen of the artery with signal attenuation.	0 to 12 months

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Chair: Shaoliang Chen, MD, Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): July 30, 2019

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: optical coherence tomography; vulnerable plaque; coronary bifurcation lesion
• Other Study ID Numbers: NFH20170423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes