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Fractional FLOw Reserve In Cardiovascular DiseAses

Fractional FLOw Reserve In Cardiovascular DiseAses

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04597489
Acronym
FLORIDA
Enrollment
64045
Registered
2020-10-22
Start date
2019-12-01
Completion date
2020-03-02
Last updated
2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Coronary Artery Disease

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

Interventions

PROCEDUREFractional flow reserve

Patients were stratified into the FFR group if a coronary angiography with adjunctive FFR measurement was performed during the index hospitalization.

PROCEDUREAngiography-only

Patients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed.

Sponsors

Abbott
CollaboratorINDUSTRY
Charite University, Berlin, Germany
CollaboratorOTHER
University Hospital, Zürich
CollaboratorOTHER
University Hospital Schleswig-Holstein
CollaboratorOTHER
Ruhr University of Bochum
CollaboratorOTHER
LinkCare GmbH
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
All-cause mortality36 monthsAll 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

MeasureTime frameDescription
All-cause mortality12 monthsProspectively assessed at a quarterly basis.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026