Fractional FLOw Reserve In Cardiovascular DiseAses

Coronary Artery Disease Clinical Trial

— FLORIDA  

Official title:

Fractional FLOw Reserve In Cardiovascular DiseAses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597489
• Other study ID #: VF/1021/1084
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: March 2, 2020

Study information

• Verified date: October 2020
• Source: LinkCare GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64045
• Est. completion date: March 2, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiovascular Diseases
• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
Germany	LinkCare GmbH	Stuttgart

Sponsors (6)

Lead Sponsor	Collaborator
LinkCare GmbH	Abbott, Charite University, Berlin, Germany, Ruhr University of Bochum, University Hospital Schleswig-Holstein, University Hospital, Zürich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	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.	36 months
Secondary	All-cause mortality	Prospectively assessed at a quarterly basis.	12 months
Secondary	All-cause mortality	Prospectively assessed at a quarterly basis.	24 months