A Fax-based Registry Regarding Clinical Indications, Complication Rates and Management Consequences of Invasive Fractional Flow Reserve Measurements
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 2,000
- Locations
- 2
- Primary Endpoint
- Revascularization
Study Overview
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •invasive fractional flow reserve measurement is performed for clinical reasons
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Revascularization
Time Frame: 1 hour
Rate of revascularization following measurement of the fractional flow reserve
Secondary Outcomes
- Number of wires(1 hour)
- Complications(1 hour)
- Administration route(1 hour)