Clinical trial NCT01233518: Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography
Official title: Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: CCTA Coronary Artery Disease CAD
Lead sponsor: HeartFlow, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Baim Institute for Clinical Research
name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
name: Minneapolis Heart Institute Foundation
First posted: 2010-11-03
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard.

Detailed description: 285 patient, prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Patients providing written informed consent
* Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography (ICA)
* Has undergone \>64 multidetector row CCTA within 60 days prior to ICA
* No cardiac interventional therapy between the CCTA and ICA

Exclusion Criteria:

* Prior coronary artery bypass graft (CABG) surgery
* Prior percutaneous coronary intervention (PCI) for which suspected coronary artery lesion(s) are within a stented coronary vessel
* Contraindication to adenosine, including 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome; severe hypotension, severe asthma, , severe COPD or bronchodilator-dependent COPD
* Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina)
* Recent prior myocardial infarction within 40 days of ICA
* Known complex congenital heart disease
* Prior pacemaker or internal defibrillator lead implantation
* Prosthetic heart valve
* Significant arrhythmia or tachycardia
* Impaired chronic renal function (serum creatinine \>1.5 mg/dl
* Patients with known anaphylactic allergy to iodinated contrast
* Pregnancy or unknown pregnancy status
* Body mass index \>35
* Patient requires an emergent procedure
* Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \<90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema
* Any active, serious, life-threatening disease with a life expectancy of less than 2 months
* Inability to comply with study procedures

Primary outcomes:
measure: Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone
timeFrame: 1 day
Secondary outcomes:
measure: Diagnostic Performance of CCTA Plus FFRCT at the Subject Level
timeFrame: 1 day
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Spring Hill Hospital
state: Alabama
Study officials:
affiliation: Weill Medical College of Cornell University
name: James K Min, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Min JK, Berman DS, Budoff MJ, Jaffer FA, Leipsic J, Leon MB, Mancini GB, Mauri L, Schwartz RS, Shaw LJ. Rationale and design of the DeFACTO (Determination of Fractional Flow Reserve by Anatomic Computed Tomographic AngiOgraphy) study. J Cardiovasc Comput Tomogr. 2011 Sep-Oct;5(5):301-9. doi: 10.1016/j.jcct.2011.08.003. Epub 2011 Aug 7.
citation: Min JK, Leipsic J, Pencina MJ, Berman DS, Koo BK, van Mieghem C, Erglis A, Lin FY, Dunning AM, Apruzzese P, Budoff MJ, Cole JH, Jaffer FA, Leon MB, Malpeso J, Mancini GB, Park SJ, Schwartz RS, Shaw LJ, Mauri L. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. JAMA. 2012 Sep 26;308(12):1237-45. doi: 10.1001/2012.jama.11274.
citation: Park HB, Heo R, O Hartaigh B, Cho I, Gransar H, Nakazato R, Leipsic J, Mancini GBJ, Koo BK, Otake H, Budoff MJ, Berman DS, Erglis A, Chang HJ, Min JK. Atherosclerotic plaque characteristics by CT angiography identify coronary lesions that cause ischemia: a direct comparison to fractional flow reserve. JACC Cardiovasc Imaging. 2015 Jan;8(1):1-10. doi: 10.1016/j.jcmg.2014.11.002.