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Fractional FLOw Reserve In Cardiovascular DiseAses

NCT ID: NCT04597489

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64045 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-03-02

Brief Summary

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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.

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Detailed Description

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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

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Coronary Artery Disease Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Angiography + FFR

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

Fractional flow reserve

Intervention Type PROCEDURE

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.

Angiography-only

Intervention Type PROCEDURE

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

Subgroup ACS

Patients were stratified by index diagnoses, i.e. acute coronary syndrome (ACS) or chronic coronary syndrome (CCS) according to the index hospital admission diagnosis.

This subgroup consists of patients presenting with ACS.

Fractional flow reserve

Intervention Type PROCEDURE

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

Angiography-only

Intervention Type PROCEDURE

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

Subgroup CCS

Patients were stratified by index diagnoses, i.e. acute coronary syndrome (ACS) or chronic coronary syndrome (CCS) according to the index hospital admission diagnosis.

This subgroup consists of patients presenting with CCS.

Fractional flow reserve

Intervention Type PROCEDURE

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

Angiography-only

Intervention Type PROCEDURE

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

Subgroup revascularization

Patients were stratified by the type of treatment, i.e. percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or conservative management with optimal medical therapy (OMT) alone, based on the procedure codes during the index hospital stay.

This subgroup consists of patients undergoing revascularization after an angiography (with or without FFR) during the index hospital stay.

Fractional flow reserve

Intervention Type PROCEDURE

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

Angiography-only

Intervention Type PROCEDURE

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

Subgroup optimal medical therapy

Patients were stratified by the type of treatment, i.e. percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or conservative management with optimal medical therapy (OMT) alone, based on the procedure codes during the index hospital stay.

This subgroup consists of patients undergoing optimal medical therapy after an angiography (with or without FFR) during the index hospital stay.

Fractional flow reserve

Intervention Type PROCEDURE

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

Angiography-only

Intervention Type PROCEDURE

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

Interventions

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Fractional flow reserve

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

Intervention Type PROCEDURE

Angiography-only

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

Intervention Type PROCEDURE

Other Intervention Names

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FFR

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

University Hospital, Zürich

OTHER

Sponsor Role collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role collaborator

Ruhr University of Bochum

OTHER

Sponsor Role collaborator

LinkCare GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tobias Vogelmann, MSc

Role: STUDY_CHAIR

LinkCare GmbH

Locations

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LinkCare GmbH

Stuttgart, , Germany

Site Status

Countries

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Germany

Other Identifiers

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VF/1021/1084

Identifier Type: -

Identifier Source: org_study_id

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