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临床试验/NCT03890822
NCT03890822Unknown不适用

Coronary Artery Disease Progression in Patients With Acute Coronary Syndromes and Diabetes Mellitus

Humanitas Hospital, Italy1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年3月25日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Percentual atheroma volume

研究概览

简要总结

A total of 100 patients with non-ST-segment elevation acute coronary syndromes with or without diabetes mellitus will be included. All patients will undergo coronary angiography with identification of the infarct-related vessel and percutaneous revascularization with implantation of a stent/scaffold. After revascularization patients will undergo a combined positron emission tomography (PET)-coronary computed tomography (CT) protocol to quantify atherosclerotic burden (i.e. plaque volume) and activity (i.e. 18 fluorum-sodium-fluoride [18FNaF] uptake) in non-infarct related vessels, to assess calcium score (aim 1), and to quantify the acute results of PCI in the infarct-related vessel (aim 2). At 12-month follow-up, all patients will repeat longitudinal 18FNaF PET-coronary CT evaluation to characterize progression of atherosclerosis in the non-infarct related vessels (aim 1) and to quantify neointimal suppression at the site of the treated coronary segment in the infarct-related vessel (aim 2). Blood samples will be collected at baseline and 12 months for all patients.

The aims of the study are:

  1. To evaluate coronary artery disease progression in acute coronary syndromes patients with and without diabetes mellitus, and to investigate the predictive value of metabolic profiles, patterns of circulating miRNAs and inflammatory mediators on coronary artery disease progression;
  2. To evaluate the progression of disease within the infarct-related vessel treated with the use of bioresorbable stent/bioresorbable polymer stents in diabetic and non-diabetic patients with acute coronary syndromes.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 and <80 years, evidence of non-ST-segment elevation acute coronary syndromes, ability to provide informed consent

排除标准

  • ST-segment elevation myocardial infarction, cardiogenic shock, suspected stent thrombosis, known allergy to aspirin or ticagrelor, childbearing potential, life expectancy <1 year due to non-cardiac disease, severe chronic kidney disease.

结局指标

主要结局

Percentual atheroma volume

时间窗: 12 months

Assessed by CT

Minimal lumen area

时间窗: 12 months

Assessed by CT

次要结局

  • Change in minimal lumen area(12 months)
  • Percentual change in 18FNaF uptake(12 months)

研究者

发起方
Humanitas Hospital, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giulio Stefanini

Head of Clinical Research, Cardio Center

Humanitas Hospital, Italy

研究点 (1)

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