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 has been completed.
Sponsor:
Information provided by:
Piedmont Healthcare
ClinicalTrials.gov Identifier:
NCT00817102
First received: January 2, 2009
Last updated: April 14, 2014
Last verified: April 2014
  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.


Condition Intervention
Coronary Artery Stenosis
Procedure: FFR, IVUS, VH, or combination of the three

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Further study details as provided by Piedmont Healthcare:

Primary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: November 2008
Study Completion Date: April 2013
Primary Completion Date: November 2011 (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.

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%.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817102

Locations
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
Piedmont Healthcare
  More Information

No publications provided by Piedmont Healthcare

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charles Brown, MD, Piedmont Healthcare
ClinicalTrials.gov Identifier: NCT00817102     History of Changes
Other Study ID Numbers: ATLANTA II
Study First Received: January 2, 2009
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Piedmont Healthcare:
coronary artery stenoses

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Stenosis
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 09, 2014