Fractional Flow Reserve Fax Registry

NCT03055910 | Unknown

• 1 other identifier: FFR_01_2017
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Revascularization

  Rate of revascularization following measurement of the fractional flow reserve

  1 hour

Secondary Outcomes (3)

• Complications

  1 hour

• Number of wires

  1 hour

• Administration route

  1 hour

Interventions

Fractional Flow Reserve Measurement DIAGNOSTIC_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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• invasive fractional flow reserve measurement is performed for clinical reasons

You may not qualify if:

• none

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Abbott Medical Devices: collaborator

Study Sites (2)

St. Johannes Hospital

Dortmund, 44137, Germany

Location

University Hospital

Erlangen, 91054, Germany

Location

Related Publications (1)

• 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.

  PMID: 38832995 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Stephan Achenbach, MD

  Friedrich Alexander University Erlangen-Nuremberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephan Achenbach, MD

CONTACT

++4991318535301; stephan.achenbach@uk-erlangen.de

Grit Herrmann

CONTACT

++4991318535301; grit.herrmann@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 16, 2017
• Study Start: March 1, 2017
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: February 16, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)