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

Coronary Artery Stenosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817102
• Other study ID #: ATLANTA II
• Status: Completed
• Phase: N/A
• First received: January 2, 2009
• Last updated: April 14, 2014
• Start date: November 2008
• Est. completion date: April 2013

Study information

• Verified date: April 2014
• Source: Piedmont Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2013
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Artery Stenosis
• Coronary Stenosis

Intervention

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.

Locations

Country	Name	City	State
United States	Piedmont Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Piedmont Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Upon completion of tests	No