Fractional FLOw Reserve In Cardiovascular DiseAses

Completed

• Conditions: Coronary Artery Disease; Acute Coronary Syndrome

• Registration Number: NCT04597489
• Lead Sponsor: LinkCare GmbH

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2019-12-01
• Primary Completion: 2020-01-20
• Study Completion: 2020-03-02
• Status Verified: 2020-10
• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-16
• Last Update Submitted: 2020-10-16
• Study First Posted: 2020-10-22
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64045

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	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.

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	24 months	Prospectively assessed at a quarterly basis.

Trial Locations

Locations (1)

LinkCare GmbH; 🇩🇪 Stuttgart, Germany