Coronary Artery DiseaseF(FR)²NCT03055910
Fractional Flow Reserve Fax Registry
An observational study of Coronary Artery Disease, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.
Trial summary
The Fractional Flow Reserve Fax Registry is an investigator-initiated, real-world registry to analyze the use of fractional flow reserve (FFR) measurements in clinical practice in cardiac catheterization laboratories in Germany. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Fractional Flow Reserve Measurement
- How many people
- 2,000 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Mar 2017to 31 Jan 2018
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with known or suspected coronary artery disease in whom invasive fractional flow reserve measurement is performed for clinical reasons in the context of coronary angiography or percutaneous coronary intervention
Who may be able to join
- invasive fractional flow reserve measurement is performed for clinical reasons
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
St. Johannes Hospital
Dortmund, 44137
Helge Moellmann, MD, PhD, ++49231184335111, helge.moellmann@joho-dortmund.de
Agnes Steinborn, ++49231184335111, inneremedizin1@joho-dortmund.de
University Hospital
Erlangen, 91054
Stephan Achenbach, MD, ++4991318535301, stephan.achenbach@uk-erlangen.de
Grit Herrmann, ++4991318535301, grit.herrmann@uk-erlangen.de
About this study
Official title: A Fax-based Registry Regarding Clinical Indications, Complication Rates and Management Consequences of Invasive Fractional Flow Reserve Measurements
The Fractional Flow Reserve Fax Registry is an investigator-initiated, real-world registry to analyze the use of fractional flow reserve (FFR) measurements in clinical practice in cardiac catheterization laboratories in Germany. The registry aims to collect the data of 2000 patients who underwent FFR recordings for clinical reasons. The main outcome parameter is the frequency of coronary revascularization following FFR. Secondary outcome parameters include the distribution of quantitative FFR results in clinical practice, the influence of intracoronary versus intravenous adenosine on the distribution of FFR results, the rate of complications as a result of FFR measurements, the average number of FFR wires needed per patient. Since the study will include a large number of patients who undergo i.c. administration of adenosine and a large number of patients who undergo i.v. administration of adenosine, it will be possible to analyze whether the route of adenosine administration is an independent predictor of the FFR result.
Read the detailed description
Patient Inclusion Criteria
All patients who undergo measurement of the Fractional Flow Reserve using intracoronary pressure measurements for clinical reasons are eligible for inclusion.
There are no exclusion criteria.
Methods
Following a clinically indicated FFR measurement, patient data and data concerning angiographic stenosis severity as well as anatomic location of the interrogated lesion, method of adenosine administration, and FFR result are documented in a paper form. The form contains no patient data except age and gender as well as the cath lab identifying number and the serial number of the used FFR wire(s). The paper form is transmitted by fax to the central study site at Erlangen University where data will be stored and all evaluations will be performed.
Recruitment period
Recruitment starts March 1, 2017 and will be terminated after 2000 patients have been included.
Number of patients
2000 patients will be included.
Outcome parameters
The main outcome parameter is the frequency of coronary revascularization following FFR.
Secondary outcome parameters include the distribution of quantitative FFR results in clinical practice, the rate of complications as a result of FFR measurements, and the average number of FFR wires needed per patient, as well as the influence of i.c. versus i.v. administration of adenosine on the distribution of obtained FFR results.
All outcome parameters will be determined immediately after the end of invasive coronary angiography (and coronary intervention, if performed) in each patient (day 0). No follow-up will be performed.
Institutional Review Board (IRB)
The study protocol has been approved by the IRB of the Faculty of Medicine, University of Erlangen-Nürnberg (File Number 4_15B). Patient consent has been waived since data will be completely anonymized and no study-specific interventions are performed.
Primary Investigator
The study primary investigator is
Stephan Achenbach
Department of Cardiology
University of Erlangen
Ulmenweg 18
91054 Erlangen
Germany
The study co-primary investigator is
Helge Möllmann
Department of Cardiology
Johannes Hospital Dortmund
Johannesstraße 9-13
44137 Dortmund
Germany
Sponsor
The study is sponsored by the University Hospital Erlangen, Department of Cardiology. It is financed through a restricted grant by Abbott Vascular
- Conditions
- Coronary Artery Disease
- Being tested
- Fractional Flow Reserve Measurement
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional Flow Reserve MeasurementDiagnostic test
Wire-based invasive measurement of the fractional flow reserve in the context of coronary angiography and percutaneous coronary intervention in order to assess the hemodynamic relevance of coronary artery stenoses
What is being measured
The primary outcome is the main question the study is designed to answer.
Revascularization
Rate of revascularization following measurement of the fractional flow reserve
Measured: 1 hour
Secondary outcomes (3)
Complications
Complication attributable to the invasive measurement of fractional flow reserve
Measured: 1 hour
Number of wires
Number of FFR wires used per patient
Measured: 1 hour
Administration route
Average FFR values obtained in the cohort when using intracoronary or intravenous injection of adenosine
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start1 Mar 2017 (estimated)
- Primary completion31 Jan 2018 (estimated)
- Study completion31 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- Stephan Achenbach, MD, Principal investigator, Friedrich Alexander University Erlangen-Nuremberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055910
- Sponsor's protocol ID
- FFR_01_2017
- Acronym
- F(FR)²
- Status last verified
- Feb 2017
- First submitted
- 14 Feb 2017
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altstidl JM, Achenbach S, Feyrer J, Nazli JB, Marwan M, Gaede L, Mollmann H, Giesler T, Rittger H, Pauschinger M, Rudolph TK, Moshage W, Bruck M, Trobs M. Use of coronary physiology to guide revascularization in clinical practice: results of the F(FR)2 registry. Clin Res Cardiol. 2024 Jul;113(7):1081-1091. doi: 10.1007/s00392-024-02463-w. Epub 2024 Jun 4.
PubMed 38832995
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Fax-based Registry Regarding Clinical Indications, Complication Rates and Management Consequences of Invasive Fractional Flow Reserve Measurements
- ClinicalTrials.gov ID
- NCT03055910
- Acronym / sponsor ID
- F(FR)² / FFR_01_2017
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 1 Mar 2017 (estimated)
- Primary completion
- 31 Jan 2018 (estimated)
- Study completion
- 31 Jan 2018 (estimated)
- First posted
- 16 Feb 2017 (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 Fractional Flow Reserve Fax Registry is an investigator-initiated, real-world registry to analyze the use of fractional flow reserve (FFR) measurements in clinical practice in cardiac catheterization laboratories in Germany. The registry aims to collect the data of 2000 patients who underwent FFR recordings for clinical reasons. The main outcome parameter is the frequency of coronary revascularization following FFR. Secondary outcome parameters include the distribution of quantitative FFR results in clinical practice, the influence of intracoronary versus intravenous adenosine on the distribution of FFR results, the rate of complications as a result of FFR measurements, the average number of FFR wires needed per patient. Since the study will include a large number of patients who undergo i.c. administration of adenosine and a large number of patients who undergo i.v. administration of adenosine, it will be possible to analyze whether the route of adenosine administration is an independent predictor of the FFR result.
Detailed description
Patient Inclusion Criteria
All patients who undergo measurement of the Fractional Flow Reserve using intracoronary pressure measurements for clinical reasons are eligible for inclusion.
There are no exclusion criteria.
Methods
Following a clinically indicated FFR measurement, patient data and data concerning angiographic stenosis severity as well as anatomic location of the interrogated lesion, method of adenosine administration, and FFR result are documented in a paper form. The form contains no patient data except age and gender as well as the cath lab identifying number and the serial number of the used FFR wire(s). The paper form is transmitted by fax to the central study site at Erlangen University where data will be stored and all evaluations will be performed.
Recruitment period
Recruitment starts March 1, 2017 and will be terminated after 2000 patients have been included.
Number of patients
2000 patients will be included.
Outcome parameters
The main outcome parameter is the frequency of coronary revascularization following FFR.
Secondary outcome parameters include the distribution of quantitative FFR results in clinical practice, the rate of complications as a result of FFR measurements, and the average number of FFR wires needed per patient, as well as the influence of i.c. versus i.v. administration of adenosine on the distribution of obtained FFR results.
All outcome parameters will be determined immediately after the end of invasive coronary angiography (and coronary intervention, if performed) in each patient (day 0). No follow-up will be performed.
Institutional Review Board (IRB)
The study protocol has been approved by the IRB of the Faculty of Medicine, University of Erlangen-Nürnberg (File Number 4_15B). Patient consent has been waived since data will be completely anonymized and no study-specific interventions are performed.
Primary Investigator
The study primary investigator is
Stephan Achenbach
Department of Cardiology
University of Erlangen
Ulmenweg 18
91054 Erlangen
Germany
The study co-primary investigator is
Helge Möllmann
Department of Cardiology
Johannes Hospital Dortmund
Johannesstraße 9-13
44137 Dortmund
Germany
Sponsor
The study is sponsored by the University Hospital Erlangen, Department of Cardiology. It is financed through a restricted grant by Abbott Vascular
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with known or suspected coronary artery disease in whom invasive fractional flow reserve measurement is performed for clinical reasons in the context of coronary angiography or percutaneous coronary intervention
Key inclusion criteria (1 listed)
- invasive fractional flow reserve measurement is performed for clinical reasons
Key exclusion criteria (1 listed)
- none
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 Reserve MeasurementWire-based invasive measurement of the fractional flow reserve in the context of coronary angiography and percutaneous coronary intervention in order to assess the hemodynamic relevance of coronary artery stenoses | Diagnostic test | – |
Primary outcome
Revascularization
Time frame: 1 hour
Rate of revascularization following measurement of the fractional flow reserve
3 secondary outcomes
Complications
Time frame: 1 hour
Number of wires
Time frame: 1 hour
Administration route
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
- Derived from this study: PubMed 38832995Altstidl JM, Achenbach S, Feyrer J, Nazli JB, Marwan M, Gaede L, Mollmann H, Giesler T, Rittger H, Pauschinger M, Rudolph TK, Moshage W, Bruck M, Trobs M. Use of coronary physiology to guide revascularization in clinical practice: results of the F(FR)2 registry. Clin Res Cardiol. 2024 Jul;113(7):1081-1091. doi: 10.1007/s00392-024-02463-w. Epub 2024 Jun 4.
- 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.
Stephan Achenbach, MD principal investigator
Friedrich Alexander University Erlangen-Nuremberg
2 sites 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, run by University of Erlangen-Nürnberg Medical School at 2 sites 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: status not confirmed, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephan Achenbach, MD (++4991318535301, stephan.achenbach@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revascularization (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03055910, which also lists 1 linked publication.
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 16 Feb 2017.