Expired Study
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Atlanta, Georgia 30309


Purpose:

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.


Study summary:

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%.


Criteria:

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


Study is Available At:


Original ID:

ATLANTA II


NCT ID:

NCT00817102


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Piedmont Healthcare


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:

Actual


Study Dates

Start Date:November 2008
Completion Date:April 2013
Completion Type:Actual
Primary Completion Date:November 2011
Primary Completion Type:Actual
Verification Date:April 2014
Last Changed Date:April 14, 2014
First Received Date:January 2, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:FFR, IVUS, VH, or combination of the three
Description: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.
Arm Name:CorCTA

Study Arms

Study Arm Type:Other
Arm Name:CorCTA
Description:Fractional Flow Reserve (FFR), Intravascular Ultrasound (IVUS), Virtual Histology (VH) or some combination of these three procedures

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Piedmont Healthcare

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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