Multimodality Imaging and Functional Lesion Assessment in Intermediate Grade Coronary Stenosis in Chronic Coronary Syndrome: MultiInter-CCS Study
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 fractional flow reserve (FFR) and mean 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 functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma 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 functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters evaluated by OCT including minimal lumen area, plaque stratification into fibrotic, calcific, lipidic plaque, or thin cap fibroatheroma) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.
The additional objectives include: evaluation of the impact of age, sex, diabetes mellitus, renal dysfunction on the assocation between functional and morphometric indices of coronary stenosis.
We hypothesized that in patients with intermediate grade coronary stenosis in chronic coronary syndorme there is a positive correlation between the functional parameters and the morphometric parameters of cornary 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
- •FFR and OCT examination of the same lesion
- •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 fractional flow reserve (FFR) and mean lumen area within the coronary stenosis
时间窗: Baseline
Correlation between fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis
时间窗: Baseline
次要结局
- Major adverse cardiovascular events(36 months)
研究者
Mariusz Tomaniak
MD, PhD, FESC
Medical University of Warsaw