Performing Fractional Flow Reserve Without Anticoagulation During Diagnostic Catheterization
February 11, 2009 updated by: Clinyx, LLC
Retrospective Assessment of the Safety of Performing Fractional Flow Reserve (FFR) of the Myocardium Without Anticoagulation During Diagnostic Cardiac Catheterization
The purpose of this study is to assess the safety of performing fractional flow reserve (FFR) of the myocardium without using anticoagulation by performing a retrospective review of 100 consecutive patients who have undergone this procedure during diagnostic catheterization.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
An experienced interventional cardiologist can perform FFR in a brief period of time.
This procedure can safely be performed without anticoagulation, thereby lowering the associated procedural risks by avoiding the bleeding and groin complications that may occur with anticoagulation.
Performing FFR without anticoagulation may also decrease facility costs as femoral artery closure can be performed using standard protocols for a diagnostic procedure, instead of standard protocols for an interventional procedure when a patient has been anticoagulated.
Performing FFR without anticoagulation does not increase risk of injury to the coronary artery or thrombus in the coronary artery.
Study Type
Observational
Enrollment (Actual)
100
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
Patients who underwent fractional flow reserve (FFR) by Dr. Jonathan Roberts without anticoagulation during diagnostic catheterization were included in this registry.
Description
Inclusion Criteria:
- Patients with moderate stenosis who underwent FFR without anticoagulation
Exclusion Criteria:
- Therapeutic anticoagulation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Fractional Flow Reserve
Patients with suspected coronary artery disease undergoing FFR to assess physiological significance of stenosis
|
Fractional Flow Reserve performed without anticoagulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Complications related to use of pressure wire
Time Frame: 0-30 days (index procedure)
|
0-30 days (index procedure)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Complications due to FFR procedure
Time Frame: 0-30 days (index hospitalization)
|
0-30 days (index hospitalization)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jonathan Roberts, MD, Clinyx, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
February 6, 2009
First Submitted That Met QC Criteria
February 11, 2009
First Posted (Estimate)
February 12, 2009
Study Record Updates
Last Update Posted (Estimate)
February 12, 2009
Last Update Submitted That Met QC Criteria
February 11, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.