NCT04597489

Fractional FLOw Reserve In Cardiovascular DiseAses

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64,045 (actual)
• Sponsor: LinkCare GmbH · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Coronary Artery Disease
• Acute Coronary Syndrome

Interventions

Type	Name	Description
PROCEDURE	Fractional flow reserve	Patients were stratified into the FFR group if a coronary angiography with adjunctive FFR measurement was performed during the index hospitalization.
PROCEDURE	Angiography-only	Patients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed.

Timeline

• Start date: 2019-12-01
• Primary completion: 2020-01-20
• Completion: 2020-03-02
• First posted: 2020-10-22
• Last updated: 2020-10-22

Locations

1 site across 1 country: Germany