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临床试验/NCT05111418
NCT05111418已完成不适用

Myocardial Bridge Evaluation Towards Personalised Medicine: the RIALTO Registry

Fondazione Policlinico Universitario Agostino Gemelli IRCCS5 个研究点 分布在 1 个国家目标入组 444 人开始时间: 2021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
入组人数
444
试验地点
5
主要终点
Incidence of MACE

研究概览

简要总结

Myocardial bridge (MB) is a congenital anomaly of epicardial circulation characterized by an intramural course of a coronary segment. This anatomical arrangement causes the artery to be squeezed during systole potentially causing flow impairment and ischemia. For this study, MB is defined as the presence of systolic compression in an epicardial vessel causing at least 50% of caliber reduction from diastole. MB can be disabling as it worsens the quality of life. Early detection of this congenital condition is crucial, and an invasive functional assessment of the ischemic burden should be considered to evaluate the need for medical or surgical therapy.

This is an observational study, involving four Italian centres. Study Objectives are: To assess the risk of future cardiovascular complications in patients with MB referred for coronary angiography and the role of beta-blocker therapy; To describe the clinical and anatomical characteristics of patients presenting with MB; To determine the impact of cardiovascular medications on symptoms in patients with MB; To describe the anatomical and clinical features associated with the invasive evidence of ischemia in patients with MB; To assess the relation between invasively documented ischemia and clinical manifestations in patients with the MB. Inclusion Criteria: patients referred to undergo ICA (for both elective or urgent indications) for suspected coronary artery disease found to have an MB with or without other epicardial lesions amenable to revascularization; Age above 18 y.o.; Ability to provide Informed Consent. Exclusion Criteria are Patients with life expectancy below 12 months and Patients with severe valvular heart disease. The primary endpoint is the incidence of MACE defined as the composite of cardiac death, myocardial infarction, cardiac hospitalization, and target vessel revascularization. The secondary endpoint is evaluating the Rate of patients with SAQ < 70 and the Rate of patients with "high-risk features" on CT scan.

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 referred to undergo ICA (for both elective or urgent indications) for suspected coronary artery disease found to have a myocardial bridge with or without other epicardial lesions amenable to revascularization
  • Age above 18 y.o.
  • Ability to provide Informed Consent

排除标准

  • Patients with life expectancy below 12 months
  • Patients with severe valvular heart disease

结局指标

主要结局

Incidence of MACE

时间窗: 2 years follow up

Incidence of MACE defined as the composite of cardiac death, myocardial infarction, cardiac hospitalization and target vessel revascularization

次要结局

  • Rate of patients with "high risk features" on CT scan(2 years follow up)
  • Rate of patients with SAQ < 70(2 years follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

DAMARIO DOMENICO

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (5)

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