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临床试验/NCT03796741
NCT03796741已完成不适用

STable Coronary Artery Diseases RegisTry

Heart Care Foundation182 个研究点 分布在 1 个国家目标入组 5,070 人开始时间: 2016年3月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5,070
试验地点
182
主要终点
Number of patients in medical therapy and that underwent revascularization

研究概览

简要总结

Observational, prospective multicentric, national study, evaluating the diagnostic and therapeutic pathways of patient with cronic coronary artery disease followed in Italian cardiology centers.

详细描述

Coronary heart disease is still highly prevalent in the world, and chronic stable angina is one of the most common clinical presentations of this disease. The objectives of chronic stable angina treatment include the reduction of symptoms, the inhibition or slowing of the progression of the disease, the prevention of associated cardiovascular events such as myocardial infarction, and the possible improvement of survival.The results of COURAGE Study and of meta-analysis of more recent studies demonstrate that patients in optimized medical therapy (OMT) (aspirin, beta-blocker and statin in association with an ACE-inhibitor and strict control of risk factors). ) the percutaneous coronary revascularization procedure (PCI) did not lead to an improvement in the cardiovascular prognosis. These data led the groups in charge of drafting the guidelines to recommend OMT as an initial treatment of stable angina, reserving the revascularization procedure for those patients with symptoms not adequately controlled by medical therapy.

It is therefore considered appropriate to plan a registry in patients with stable coronary artery disease that has the ability to describe in the heterogeneity of Italian cardiological centers the current characteristics of these patients, their treatment modalities, adherence to the current guidelines both as regards invasive therapy that the optimized medical, the use and the total cost of the resources needed to manage this pathology, the clinical course one year after entering the register.

Consecutive patients discharged (after an ordinary or day hospital admission) or managed as outpatient at Cardiology department participating in the project with a diagnosis of stable coronary artery disease will be included in the register. Enrollment will last 3 months in each center, starting with the first enrolled patient, or up to 50 patients enrolled.

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

入选标准

  • Patients aged >/= 18
  • Patients discharged from hospital or ambulatory visit with a diagnoses of stable heart disease;
  • Written informed consent

排除标准

  • Acute coronary syndrome within 30 days from enrollment
  • CCS Angina Class IV
  • Angina probably not for coronary artery disease

结局指标

主要结局

Number of patients in medical therapy and that underwent revascularization

时间窗: Enrollment

Number of patients in medical therapy and that underwent revascularization

次要结局

  • All cause hospitalization rate(12 months Follow-up)
  • Angina recurrence rate(12 months Follow-up)
  • Number of patient in optimal medical therapy(12 months Follow-up)
  • Mortality rate(12 months Follow-up)

研究者

发起方
Heart Care Foundation
申办方类型
Other
责任方
Sponsor

研究点 (182)

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