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Completed

NCT Number: NCT04597489

Fractional FLOw Reserve In Cardiovascular DiseAses

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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Key information

Conditions

Coronary Artery Disease Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

LinkCare GmbH

Stuttgart, 70469, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fractional flow reserve

Procedure

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

Other names: FFR

Angiography-only

Procedure

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

Primary outcomes

  1. All-cause mortality

    Time frame: 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 outcomes

  1. All-cause mortality

    Time frame: 12 months

    Prospectively assessed at a quarterly basis.

  2. All-cause mortality

    Time frame: 24 months

    Prospectively assessed at a quarterly basis.

Sponsors and collaborators

Lead sponsor

LinkCare GmbH

Industry

Collaborators

  • Abbott
  • Charite University, Berlin, Germany
  • Ruhr University of Bochum
  • University Hospital Schleswig-Holstein
  • University Hospital, Zürich

Registry information

Acronym: FLORIDA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2020
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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