Home
Search
Study Topics
Glossary
|
Study 10 of 420 for search of: | received on or after 12/30/2008 |
Previous Study | Return to Search Results | Next Study |
|
|
|
|
|
Sponsors and Collaborators: |
Piedmont Healthcare Abbott Vascular |
---|---|
Information provided by: | Piedmont Healthcare |
ClinicalTrials.gov Identifier: | NCT00817102 |
This study will evaluate the effectiveness of CorCTA by comparing the results of the test with another imaging method called Fractional Flow Reserve (FFR), which is done as a part of the cardiac catheterization.
Condition | Intervention |
---|---|
Coronary Artery Stenosis |
Procedure: FFR, IVUS, VH, or combination of the three |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Single Group Assignment |
Estimated Enrollment: | 25 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
CorCTA
Fractional Flow Reserve (FFR), Intravascular Ultrasound (IVUS), Virtual Histology (VH) or some combination of these three procedures
|
Procedure: FFR, IVUS, VH, or combination of the three
Fractional Flow Reserve (FFR), Intravascular Ultrasound (IVUS), Virtual Histology (VH) or some combination of these three procedures will be completed during the cardiac catheterization procedure.
|
Invasive X-ray coronary angiography remains the "reference standard" for the evaluation of coronary artery stenoses. Recently, coronary artery computed tomography angiography (CorCTA) has been introduced as a non-invasive method for the evaluation of coronary artery stenoses and has been shown to be highly accurate in stenosis detection when compared to invasive X-ray angiography. While invasive X-ray angiography and CorCTA evaluate morphological features of coronary arterial plaques, fractional flow reserve is an invasive measure of the hemodynamic significance of a stenosis obtained in the catheterization laboratory by measuring changes in intracoronary arterial pressure before and after maximal vasodilation induced by intracoronary adenosine. An FFR value less than 0.75 has been shown to predict ischemia in vascular beds distal to the stenosis by radionuclide perfusion modalities and has been shown to be associated with worse outcomes. Therefore, FFR is considered to be an invasive hemodynamic "reference standard" for the evaluation of the hemodynamic significance of coronary arterial stenoses. While intravascular ultrasound (IVUS) can provide additional morphological information in intermediate stenoses, it can not provide further functional information and cannot be used in more significant stenoses as the IVUS probe cannot be advanced through stenotic lesions.
We are currently conducting investigation in the validation of CorCTA against FFR in intermediate coronary artery stenoses (40-70%) (see below under "Preliminary Data"). However, CorCTA has not been validated against invasive hemodynamic measurements of fractional flow reserve in patients with stenoses >70% by invasive X-ray angiography. We hypothesize that CorCTA-derived measurements are accurate in the diagnosis of hemodynamically significant coronary artery stenoses, using FFR as the reference standard in patients with coronary artery stenoses>70%.
Ages Eligible for Study: | 21 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Presence of at least one obstructive coronary artery stenosis as defined by:
Exclusion Criteria:
Contact: Laura Murrieta | 404-605-3074 | laura.murrieta@piedmont.org |
Contact: Mary Harmon | 404-605-3068 | mary.harmon@piedmont.org |
United States, Georgia | |
Piedmont Hospital | Recruiting |
Atlanta, Georgia, United States, 30309 | |
Contact: Laura Murrieta 404-605-3074 laura.murrieta@piedmont.org | |
Contact: Mary Harmon 404-605-3068 mary.harmon@piedmont.org |
Responsible Party: | Piedmont Healthcare ( Szilard Voros, MD ) |
Study ID Numbers: | ATLANTA II |
Study First Received: | January 2, 2009 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00817102 |
Health Authority: | United States: Institutional Review Board |
coronary artery stenoses |
Coronary Disease Pathological Conditions, Anatomical Heart Diseases Myocardial Ischemia Vascular Diseases |
Constriction, Pathologic Ischemia Coronary Stenosis Coronary Artery Disease |
Cardiovascular Diseases |