Fractional Flow Reserve Fax Registry

NCT ID: NCT03055910

Last Updated: 2017-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-01-31

Brief 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. 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

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Fractional Flow Reserve Measurement

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• invasive fractional flow reserve measurement is performed for clinical reasons

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan Achenbach, MD

Role: PRINCIPAL_INVESTIGATOR

Friedrich Alexander University Erlangen-Nuremberg

Locations

St. Johannes Hospital

Dortmund, , Germany

University Hospital

Erlangen, , Germany

Countries

Germany

Central Contacts

Stephan Achenbach, MD

Role: CONTACT

stephan.achenbach@uk-erlangen.de

++4991318535301

Grit Herrmann

Role: CONTACT

grit.herrmann@uk-erlangen.de

++4991318535301

Facility Contacts

Helge Moellmann, MD, PhD

Role: primary

helge.moellmann@joho-dortmund.de

++49231184335111

Agnes Steinborn

Role: backup

inneremedizin1@joho-dortmund.de

++49231184335111

Stephan Achenbach, MD

Role: primary

stephan.achenbach@uk-erlangen.de

++4991318535301

Grit Herrmann

Role: backup

grit.herrmann@uk-erlangen.de

++4991318535301

References

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.

Reference Type: DERIVED

PMID: 38832995 (View on PubMed)

Other Identifiers

FFR_01_2017

Identifier Type: -

Identifier Source: org_study_id