A prospective, Single-Centre study to investigate the plaque characteristics in the culprit vessels in young Indian patients (≥18 - ≤40 yrs) with ACS undergoing PCI by Optical Coherence Tomography imaging.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Plaque Characteristics
研究概览
简要总结
Acute coronary syndrome (ACS) is characterized by rapid stenosis or occlusion of the lumen caused by coronary thrombus formation, resulting in myocardial ischemia or necrosis. It is classified into ST-elevation acute myocardial infarction (STEMI), non-ST-elevation acute myocardial infarction (NSTEMI), and unstable angina (UA). Coronary plaques in ACS are greatly different from those in stable coronary artery disease (SCAD), being characterized by various morphological features and thrombus formation within the coronary artery. Culprit lesions of ACS can be identified as occluded or severely stenotic lesions on a coronary angiogram, but non-culprit lesions that are angiographically shown to be mildly or moderately stenotic also often represent lipid or vulnerable plaques with a necrotic core, suggesting that they are likely to lead to thrombus formation.
Recent advances in intravascular imaging techniques such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT) have made it possible to assess coronary lesions in greater detail. OCT is an imaging technique that employs near-infrared light with a wavelength of about 1300 nm emitted from the tip and visualizes the vascular lumen based on the light reflected from various parts of the lumen. Because of its high resolution (10 to 15 μm), optical coherence tomography (OCT) has played an important role in elucidating the pathology of ACS by, for example, identifying thin-cap fibroatheroma (TCFA) with a large necrotic lipid core, one of the major causes of ACS, and its rupture, and characterizing coronary thrombi as red, white, or mixed thrombi based on morphology and the degree of signal attenuation
This study will evaluate the plaque characteristics (minimum lumen area, fibrous cap thickness, lipid arc extension, presence of microcalcification macrophages infiltration and microchannel formation at the explored plaques) of culprit lesions at baseline. This information will be correlated with the follow clinical data in these patients undergoing PCI for ACS in young Indian patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient is ≥ 18 and ≤ 40 years of age and going for PCI of the culprit lesion (more than 90 % diameter stenosis)
- •At least ≥1 de novo lesions in a native coronary segment with a visually estimated diameter stenosis between ≥ 40 % and < 90%
- •Patient has documented ACS (unstable angina, NSTEMI or STEMI within the previous 72 hours)
- •Patient demonstrates a left ventricular ejection fraction (LVEF) of ≥ 40% as measured prior to enrolment
- •Patient understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect.
排除标准
- •Patients with a medical condition that limits the life expectancy to 1 years or less 2) Patients scheduled to undergo surgery within 3 months that requires interruption of DAPT 3) Women who are pregnant or planning to be pregnant 4) Patients with allergy to contrast agents 5) Patients with coronary artery occlusion occurring at a site where a stent has already been placed or in whom observation by OCT is considered difficult 6) Patients in shock 7) Patients with a history of adverse reactions to aspirin, clopidogrel, or prasugrel 8) Patients who are ineligible for the study in the opinion of the investigator 9) Patients in whom follow-up at 12 months after the index procedure is considered difficult 10) Patients with renal failure with a serum creatinine level of 2.0 mg/dL or more at presentation (non-HD patients) 11) Patients with active heart failure 12) Patients with acute Mitral regurgitation.
结局指标
主要结局
Plaque Characteristics
时间窗: Baseline and 1 year
次要结局
- Incidence of MACE, a composite of Cardiac(Death, MI or re-hospitalization for progressive)
研究者
Dr Nityanand Tripathi
Fortis Hospital, Shalimar Bagh