Vessel Imaging Using Optical Coherence Tomography for Plaque Morphology and Vessel Fractional Flow Reserve
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis
研究概览
简要总结
The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between mopphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma and a functional index - angiography based vessel fractional flow reserve (vFFR) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.
详细描述
This is a prospective, single center, non-randomized, single-arm, investigator-initiated study evaluating diagnostic accuracy and correlations between morphometric indices: luminal and qualitative parameters evaluated by optical coherence tomography (OCT) including minimal lumen area, plaque stratification into fibrotic, calcific, lipidic plaque, or thin cap fibroatheroma and a functional index - angiography based vessel fractional flow reserve (vFFR) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.
The additional objectives encompass assessing the influence of age, sex, diabetes mellitus, renal dysfunction on the relationship between vFFR results and morphometric indices of intermediate coronary stenosis.
We hypothesized that in patients with intermediate grade coronary stenosis in chronic coronary syndrome a positive correlation exists between vFFR and the morphometric parameters associated with coronary stenosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Chronic coronary syndrome defined as presence of chest pain ranked 2-3 in the Canadian Cardiovascular Society classification or positive ischemia test (exercise test, single photon emission tomography (SPECT)
- •Intermediate grade coronary stenosis of 40-80% assessed visually in coronary angiography and OCT examination The patient is willing to participate in the study and has provided a written informed consent
排除标准
- •Acute coronary syndrome
- •Proximal left main lesion
- •Ostial right coronary artery lesion
- •Bypass of the assessed vessel
- •Contraindications for adenosine administration
- •Hemodynamic instability
- •Heart insufficiency in New York Heart Association (NYHA) class IV scale
- •Acute renal insufficiency
- •Pregnancy
结局指标
主要结局
Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis
时间窗: 0 days
Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis
次要结局
- Major adverse cardiovascular events(36 months)
研究者
Mariusz Tomaniak
Mariusz Tomaniak, MD, PhD, Assoc. Prof.
Medical University of Warsaw