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临床试验/NCT04597489
NCT04597489已完成不适用

Fractional FLOw Reserve In Cardiovascular DiseAses

LinkCare GmbH1 个研究点 分布在 1 个国家目标入组 64,045 人开始时间: 2019年12月1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
LinkCare GmbH
入组人数
64,045
试验地点
1
主要终点
All-cause mortality

研究概览

简要总结

The FLORIDA (Fractional FLOw Reserve In cardiovascular DiseAses) study sought to investigate outcomes of FFR-guided versus angiography-guided treatment strategies in a large, real-world cohort.

详细描述

The objective of the FLORIDA study was to investigate mortality outcomes of FFR-guided versus angiography-guided treatment strategies in a large, real-world patient cohort, including patients with different stages of coronary artery disease as well as patients with acute coronary syndrome (ACS). All patients were followed for a period of 3 years after the index date. The analysis period extended from the individual index date to the date of death or the end of the 3-year follow-up period. Patients were matched for sex, presence of acute coronary syndrome, age ± 5 years, and propensity scores estimated with logistic regression based on 72 variables , with each FFR patient matched to the closest angiography-only patient

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • At least one inpatient coronary angiography for suspected coronary artery disease between January 2014 and December 2015.

排除标准

  • Loss to follow-up of other reasons than death (i.e. change of insurance)

结局指标

主要结局

All-cause mortality

时间窗: 36 months

All patients were followed for a period of 3 years after the index date. The analysis period extended from the individual index date to the date of death or the end of the 3-year follow-up period. The primary endpoint was mortality at 3 years, prospectively assessed at a quarterly basis.

次要结局

  • All-cause mortality(24 months)

研究者

发起方
LinkCare GmbH
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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