Fractional Flow Reserve Fax Registry

Coronary Artery Disease Clinical Trial

— F(FR)²  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03055910
• Other study ID #: FFR_01_2017
• Status: Not yet recruiting
• Phase: N/A
• First received: February 14, 2017
• Last updated: February 15, 2017
• Start date: March 1, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: February 2017
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Stephan Achenbach, MD
• Phone: ++4991318535301
• Email: stephan.achenbach[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• invasive fractional flow reserve measurement is performed for clinical reasons

Exclusion Criteria:

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Germany	St. Johannes Hospital	Dortmund
Germany	University Hospital	Erlangen

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Abbott Vascular

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revascularization	Rate of revascularization following measurement of the fractional flow reserve	1 hour
Secondary	Complications	Complication attributable to the invasive measurement of fractional flow reserve	1 hour
Secondary	Number of wires	Number of FFR wires used per patient	1 hour
Secondary	Administration route	Average FFR values obtained in the cohort when using intracoronary or intravenous injection of adenosine	1 hour