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

NCT00817102 | Completed

• 1 other identifier: ATLANTA II
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Stenosis

Keywords

coronary artery stenoses

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

CorCTA

OTHER

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

Interventions

FFR, IVUS, VH, or combination of the three PROCEDURE

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.

CorCTA

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Piedmont Healthcare: lead

Study Sites (1)

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Related Publications (1)

• Vazquez-Figueroa JG, Rinehart S, Qian Z, Joshi PH, Sharma A, Lee J, Anderson H, Murrieta L, Wilmer C, Carlson H, Taylor K, Ballard W, Karmpaliotis D, Kalynych A, Brown C 3rd, Voros S. Prospective validation that vulnerable plaque associated with major adverse outcomes have larger plaque volume, less dense calcium, and more non-calcified plaque by quantitative, three-dimensional measurements using intravascular ultrasound with radiofrequency backscatter analysis : results from the ATLANTA I Study. J Cardiovasc Transl Res. 2013 Oct;6(5):762-71. doi: 10.1007/s12265-013-9473-0. Epub 2013 May 22.

  PMID: 23695823 DERIVED

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 2, 2009
• First Posted: January 6, 2009
• Study Start: November 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: April 1, 2013
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

US (1)