Fractional Flow Reserve Fax Registry (F(FR)²)

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: Fractional Flow Reserve Measurement

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• Germany
  • Dortmund, Germany, 44137
    • St. Johannes Hospital
  • Erlangen, Germany, 91054
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• invasive fractional flow reserve measurement is performed for clinical reasons

Exclusion Criteria:

• none

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revascularization	Rate of revascularization following measurement of the fractional flow reserve	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Complication attributable to the invasive measurement of fractional flow reserve	1 hour
Number of wires	Number of FFR wires used per patient	1 hour
Administration route	Average FFR values obtained in the cohort when using intracoronary or intravenous injection of adenosine	1 hour

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Stephan Achenbach, MD, Friedrich Alexander University Erlangen-Nuremberg

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2017
• Primary Completion (Anticipated): January 31, 2018
• Study Completion (Anticipated): January 31, 2018

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): February 16, 2017
• Last Update Submitted That Met QC Criteria: February 15, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: FFR_01_2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No