Clinical trial NCT03172845: Optical Coherence Tomography (OCT) Findings and Coronary Bifurcation Lesions
Official title: Prevalence of Vulnerable Plaque Its Location and Clinical Significance in Bifurcation Lesions Detected by Optical Coherence Tomography.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Bifurcation Lesions
Keywords: coronary bifurcation lesion
optical coherence tomography
vulnerable plaque
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: The prevalence of coronary vulnerable plaques in bifurcation lesions using coherence tomography (OCT)
timeFrame: Documentation of baseline OCT
Secondary outcomes:
measure: Major Adverse Cardiovascular Events (MACE)
timeFrame: 0 to 12 months
measure: Stent Thrombosis
timeFrame: 0 to 12 months
measure: Thin-cap fibroatheroma
timeFrame: 0 to 12 months
measure: Calcified nodule
timeFrame: 0 to 12 months
measure: Plaque erosion
timeFrame: 0 to 12 months
measure: Plaque rupture
timeFrame: 0 to 12 months
measure: Thrombus
timeFrame: 0 to 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Shaoliang Chen, MD
role: STUDY_CHAIR
References: