Fractional FLOw Reserve In Cardiovascular DiseAses (FLORIDA)

October 16, 2020 updated by: LinkCare GmbH
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64045

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Stuttgart, Germany, 70469
        • LinkCare GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Out of a dataset of 4,395,540 anonymized age- and sex-stratified people from an anonymized German health claims database, patients undergoing at least one inpatient coronary angiography for suspected coronary artery disease between January 2014 and December 2015 were included in the analysis. The discharge date of the first hospital stay involving a coronary angiography was defined as the patient's individual index date. Patients were included into the study population regardless of their underlying disease (all-comers approach), if they were observable for at least four years (one year prior the time of inclusion and three years after the time of inclusion), or died within follow-up.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Angiography + FFR
Patients were stratified into the FFR group if a coronary angiography with adjunctive FFR measurement was performed during the index hospitalization.
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.
Other Names:
  • FFR
Angiography only
Patients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed.
Procedure: Angiography-only
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.
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.
Other Names:
  • FFR
Procedure: Angiography-only
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.
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.
Other Names:
  • FFR
Procedure: Angiography-only
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.
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.
Other Names:
  • FFR
Procedure: Angiography-only
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.
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.
Other Names:
  • FFR
Procedure: Angiography-only
Patients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 12 months
Prospectively assessed at a quarterly basis.
12 months
All-cause mortality
Time Frame: 24 months
Prospectively assessed at a quarterly basis.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LinkCare GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Charite University, Berlin, Germany
Abbott
Ruhr University of Bochum
University Hospital Schleswig-Holstein
University Hospital, Zürich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Tobias Vogelmann, MSc, LinkCare GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VF/1021/1084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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