Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055910
Recruitment Status : Unknown
Verified February 2017 by University of Erlangen-Nürnberg Medical School.
Recruitment status was:  Not yet recruiting
First Posted : February 16, 2017
Last Update Posted : February 16, 2017
Sponsor:
Collaborator:
Abbott Medical Devices
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Diagnostic Test: Fractional Flow Reserve Measurement

Show Show detailed description

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: A Fax-based Registry Regarding Clinical Indications, Complication Rates and Management Consequences of Invasive Fractional Flow Reserve Measurements
Estimated Study Start Date : March 1, 2017
Estimated Primary Completion Date : January 31, 2018
Estimated Study Completion Date : January 31, 2018

Intervention Details:
  • 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


Primary Outcome Measures :
  1. Revascularization [ Time Frame: 1 hour ]
    Rate of revascularization following measurement of the fractional flow reserve


Secondary Outcome Measures :
  1. Complications [ Time Frame: 1 hour ]
    Complication attributable to the invasive measurement of fractional flow reserve

  2. Number of wires [ Time Frame: 1 hour ]
    Number of FFR wires used per patient

  3. Administration route [ Time Frame: 1 hour ]
    Average FFR values obtained in the cohort when using intracoronary or intravenous injection of adenosine



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • invasive fractional flow reserve measurement is performed for clinical reasons

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055910


Contacts
Layout table for location contacts
Contact: Stephan Achenbach, MD ++4991318535301 stephan.achenbach@uk-erlangen.de
Contact: Grit Herrmann ++4991318535301 grit.herrmann@uk-erlangen.de

Locations
Layout table for location information
Germany
St. Johannes Hospital
Dortmund, Germany, 44137
Contact: Helge Moellmann, MD, PhD    ++49231184335111    helge.moellmann@joho-dortmund.de   
Contact: Agnes Steinborn    ++49231184335111    inneremedizin1@joho-dortmund.de   
University Hospital
Erlangen, Germany, 91054
Contact: Stephan Achenbach, MD    ++4991318535301    stephan.achenbach@uk-erlangen.de   
Contact: Grit Herrmann    ++4991318535301    grit.herrmann@uk-erlangen.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Abbott Medical Devices
Investigators
Layout table for investigator information
Principal Investigator: Stephan Achenbach, MD Friedrich Alexander University Erlangen-Nuremberg
Additional Information:

Layout table for additonal information
Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03055910    
Other Study ID Numbers: FFR_01_2017
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases