Validation of Stenosis Assessment by Coronary Artery Computed Tomography Against Invasive Measurements of Fractional Flow Reserve in Patients With Significant Coronary Artery Stenoses

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by:

Piedmont Healthcare

ClinicalTrials.gov Identifier:

NCT00817102

First received: January 2, 2009

Last updated: June 16, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	January 2, 2009
Last Updated Date	June 16, 2011
Start Date ^ICMJE	November 2008
Estimated Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 5, 2009)	The CT-derived endpoints: Study lesion %DS predicting FFR<0.75; %AS predicting FFR<0.75; MLD predicting FFR<0.75; Study lesion MLA predicting FFR<0.75; IVUS-derived endpoints: Study lesion MLD predicting FFR<0.75; MLA predicting FFR<0.75 [ Time Frame: Upon completion of tests ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00817102 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Validation of Stenosis Assessment by Coronary Artery Computed Tomography Against Invasive Measurements of Fractional Flow Reserve in Patients With Significant Coronary Artery Stenoses
Official Title ^ICMJE	Not Provided
Brief Summary	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.
Detailed Description	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%.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Coronary Artery Stenosis
Intervention ^ICMJE	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.
Study Arm (s)	CorCTA Fractional Flow Reserve (FFR), Intravascular Ultrasound (IVUS), Virtual Histology (VH) or some combination of these three procedures Intervention: Procedure: FFR, IVUS, VH, or combination of the three
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	25
Estimated Completion Date	January 2012
Estimated Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age 21-85 Presence of at least one obstructive coronary artery stenosis as defined by: Previous catheterization or CT angiogram with any lesion 70% or greater Previous positive functional stress test (this does not include CTA alone) Ability and Willingness to provide informed consent Ability and Willingness to perform required follow up procedures Exclusion Criteria: History of coronary artery bypass graft surgery Previously revascularized lesion Creatinine>1.6 mg/dL or GFR<30 pre-procedure per institutional standards Known Pregnancy Inability to perform CTA Arrhythmia precluding diagnostic CT examination Contrast agent allergy that cannot be adequately premedicated Severe PVD precluding cardiac catheterization Patient not a candidate for IVUS and FFR Inability or unwillingness to provide informed consent Inability or unwillingness to perform required follow up procedures
Gender	Both
Ages	21 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00817102
Other Study ID Numbers ^ICMJE	ATLANTA II
Has Data Monitoring Committee	No
Responsible Party	Charles Brown, MD, Piedmont Healthcare
Study Sponsor ^ICMJE	Piedmont Healthcare
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Piedmont Healthcare
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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