NCT03055910

Fractional Flow Reserve Fax Registry

A Fax-based Registry Regarding Clinical Indications, Complication Rates and Management Consequences of Invasive Fractional Flow Reserve Measurements

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-01-31
• Completion: 2018-01-31
• First posted: 2017-02-16
• Last updated: 2017-02-16

Locations

2 sites across 1 country: Germany