Coronary Artery DiseaseFLORIDANCT04597489
Fractional FLOw Reserve In Cardiovascular DiseAses
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by LinkCare GmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome
- What is being tested?
- Fractional flow reserve and Angiography-only
- Type of treatment
- Surgery or procedure
- How many people
- 64,045 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2019to 2 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- At least one inpatient coronary angiography for suspected coronary artery disease between January 2014 and December 2015.
Who cannot join
- Loss to follow-up of other reasons than death (i.e. change of insurance)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Being tested
- Fractional flow reserve, Angiography-only
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional flow reserveProcedure or surgery
Also called FFR
Patients were stratified into the FFR group if a coronary angiography with adjunctive FFR measurement was performed during the index hospitalization.
Angiography-onlyProcedure or surgery
Patients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed.
| Study group | Role | What they receive |
|---|---|---|
| Angiography + FFR | Patients were stratified into the FFR group if a coronary angiography with adjunctive FFR measurement was performed during the index hospitalization. Receives: Procedure: Fractional flow reserve | |
| Angiography only | Patients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed. Receives: Procedure: Angiography-only | |
| 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. Receives: Procedure: Fractional flow reserve; Procedure: Angiography-only | |
| 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. Receives: Procedure: Fractional flow reserve; Procedure: Angiography-only | |
| 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. Receives: Procedure: Fractional flow reserve; Procedure: Angiography-only | |
| 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. Receives: Procedure: Fractional flow reserve; Procedure: Angiography-only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (2)
All-cause mortality
Prospectively assessed at a quarterly basis.
Measured: 12 months
All-cause mortality
Prospectively assessed at a quarterly basis.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Dec 2019
- Primary completion20 Jan 2020
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 64,045 participants (actual)
Sponsor and investigators
- Lead sponsor
- LinkCare GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott, Charite University, Berlin, Germany, University Hospital, Zürich, University Hospital Schleswig-Holstein, Ruhr University of Bochum
- Responsible party
- Sponsor
- Investigators
- Tobias Vogelmann, MSc, Study chair, LinkCare GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597489
- Sponsor's protocol ID
- VF/1021/1084
- Acronym
- FLORIDA
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional FLOw Reserve In Cardiovascular DiseAses
- ClinicalTrials.gov ID
- NCT04597489
- Acronym / sponsor ID
- FLORIDA / VF/1021/1084
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64,045 participants (actual)
- Lead sponsor
- LinkCare GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Abbott, Charite University, Berlin, Germany, University Hospital, Zürich, University Hospital Schleswig-Holstein, Ruhr University of Bochum
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Angiography + FFR | – | Procedure: Fractional flow reservePatients were stratified into the FFR group if a coronary angiography with adjunctive FFR measurement was performed during the index hospitalization. |
| Angiography only | – | Procedure: Angiography-onlyPatients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed. |
| Subgroup ACS | – | Procedure: Fractional flow reserve, Procedure: Angiography-onlyPatients 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. |
| Subgroup CCS | – | Procedure: Fractional flow reserve, Procedure: Angiography-onlyPatients 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. |
| Subgroup revascularization | – | Procedure: Fractional flow reserve, Procedure: Angiography-onlyPatients 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. |
| Subgroup optimal medical therapy | – | Procedure: Fractional flow reserve, Procedure: Angiography-onlyPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- At least one inpatient coronary angiography for suspected coronary artery disease between January 2014 and December 2015.
Key exclusion criteria (1 listed)
- Loss to follow-up of other reasons than death (i.e. change of insurance)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional flow reserveAlso: FFRPatients were stratified into the FFR group if a coronary angiography with adjunctive FFR measurement was performed during the index hospitalization. | Procedure or surgery | Angiography + FFR, Subgroup ACS, Subgroup CCS, Subgroup optimal medical therapy, Subgroup revascularization |
| Angiography-onlyPatients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed. | Procedure or surgery | Angiography only, Subgroup ACS, Subgroup CCS, Subgroup optimal medical therapy, Subgroup revascularization |
Primary outcome
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.
2 secondary outcomes
All-cause mortality
Time frame: 12 months
All-cause mortality
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Vogelmann, MSc study chair
LinkCare GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by LinkCare GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.