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HeartFlowNXT - HeartFlow Analysis of Coronary Blood Flow Using Coronary CT Angiography

NCT ID: NCT01757678

Last Updated: 2017-11-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-09-30

Brief Summary

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To determine the diagnostic performance of FFRCT by coronary computed tomographic angiography (cCTA), as compared to cCTA alone, for non-invasive determination of the presence of a hemodynamically significant coronary lesion, using direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard.

Detailed Description

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Recently, coronary Computed Tomography Angiography (cCTA) of 64-detector rows or greater has emerged as a novel non-invasive imaging modality that is capable of providing high-resolution images of coronary artery lesions (Budoff 2008; Miller 2008; Meijboom 2008). While cCTA demonstrates good diagnostic performance for detection and exclusion of anatomic coronary artery stenoses, numerous prior studies have revealed an unreliable relationship between detection of obstructive anatomic coronary artery stenoses by cCTA and hemodynamically (HD)-significant coronary artery disease (CAD), identified by myocardial perfusion SPECT or fractional flow reserve (FFR) (Di Carli 2007; Klauss 2007; Rispler 2007; van Werkhoven 2009). Individual subjects may have HD-significant CAD despite cCTA assessment demonstrating angiographically mild (\<50%) maximal stenosis (Schuijf 2006). These findings emphasize the need for additional measures beyond anatomic stenosis severity for the detection and exclusion of HD-significant CAD.

Measurement of FFR during invasive cardiac catheterization represents the "gold standard" for assessment of the hemodynamic significance of coronary artery lesions (Kern 2010). Anatomic coronary artery stenosis assessment by quantitative coronary angiography (QCA) also correlates very poorly with FFR Melikian 2010). This was highlighted by the results of the FAME study in which FFR-guided coronary revascularization improved healthcare and economic outcomes compared to the conventional angiographically guided strategy (Pijls 2010; Tonino 2009; Tonino 2010).

The major disadvantage of FFR is that it has to be measured invasively. HeartFlow, Inc. ('HeartFlow') has recently developed a non-invasive method to determine FFR which computes the hemodynamic significance of CAD (FFRCT) from subject-specific cCTA data using computational fluid dynamics under rest and simulated maximal coronary hyperemic conditions. Preliminary results in subjects suggest that FFRCT accurately predicts the hemodynamic significance of coronary lesions when compared to directly-measured FFR during invasive cardiac catheterization (Koo 2011).

Conditions

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Coronary Artery Disease

Keywords

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Coronary Artery Disease Computed Fractional Flow Reserve

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective, multicenter study to evaluate the diagnostic performance of cCTA plus FFRCT employing ≥64-detector row CT scanners for the detection and exclusion of significant obstructive CAD, as defined by invasively-measured FFR, the reference standard
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

No Masking

Study Groups

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Standard of care: FFR, ICA, cCTA, FFRct

(ICA) Invasive coronary angiography with (FFR) fractional flow reserve measurement in standard of care environment, and cCTA (computed coronary tomography angiography) and FFRct Analysis (fractional flow reserve computed tomography)

Group Type OTHER

ICA (Invasive Coronary Angiography)

Intervention Type PROCEDURE

Per the protocol, patients will have an Invasive Coronary Angiography.

FFR (Fractional Flow Reserve)

Intervention Type PROCEDURE

Per the protocol, patients will have a Fractional Flow Reserve procedure.

cCTA (coronary computed tomography angiography)

Intervention Type PROCEDURE

Per the protocol, patients will have a coronary computed tomography angiography.

FFRct Analysis (Fractional Flow Reserve Computed Tomography)

Intervention Type OTHER

Per the protocol, patients will have a fractional flow reserve computed tomography.

Interventions

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ICA (Invasive Coronary Angiography)

Per the protocol, patients will have an Invasive Coronary Angiography.

Intervention Type PROCEDURE

FFR (Fractional Flow Reserve)

Per the protocol, patients will have a Fractional Flow Reserve procedure.

Intervention Type PROCEDURE

cCTA (coronary computed tomography angiography)

Per the protocol, patients will have a coronary computed tomography angiography.

Intervention Type PROCEDURE

FFRct Analysis (Fractional Flow Reserve Computed Tomography)

Per the protocol, patients will have a fractional flow reserve computed tomography.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* Subject providing written informed consent
* Scheduled to undergo a clinically indicated Invasive Coronary Angiogram (ICA)
* Has had ≥64 multidetector row cCTA within 60 days prior to ICA or agrees to undergo cCTA with ≥64 multidetector row cCTA within 60 days prior to ICA

Exclusion Criteria

* Percutaneous coronary intervention (PCI) has been performed any time prior to ICA.
* Prior coronary artery bypass graft (CABG) surgery
* Contraindication to beta blocker agents, nitrates, or 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 30 days prior to cCTA or between cCTA and ICA
* Known complex congenital heart disease
* Prior pacemaker or internal defibrillator lead implantation
* Prosthetic heart valve
* Tachycardia or significant arrhythmia
* Impaired chronic renal function (serum creatinine \>1.5 mg/dl)
* Subjects with known anaphylactic allergy to iodinated contrast
* Pregnancy or unknown pregnancy status in subject of childbearing potential
* Body mass index \>35 at time of cCTA
* Subject 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Case Western Reserve University

OTHER

Sponsor Role collaborator

HeartFlow, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bjarne Norgaard, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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Ihdayhid AR, Norgaard BL, Gaur S, Leipsic J, Nerlekar N, Osawa K, Miyoshi T, Jensen JM, Kimura T, Shiomi H, Erglis A, Jegere S, Oldroyd KG, Botker HE, Seneviratne SK, Achenbach S, Ko BS. Prognostic Value and Risk Continuum of Noninvasive Fractional Flow Reserve Derived from Coronary CT Angiography. Radiology. 2019 Aug;292(2):343-351. doi: 10.1148/radiol.2019182264. Epub 2019 Jun 11.

Reference Type DERIVED
PMID: 31184558 (View on PubMed)

Ovrehus KA, Gaur S, Leipsic J, Jensen JM, Dey D, Botker HE, Ahmadi A, Achenbach S, Ko B, Norgaard BL. CT-based total vessel plaque analyses improves prediction of hemodynamic significance lesions as assessed by fractional flow reserve in patients with stable angina pectoris. J Cardiovasc Comput Tomogr. 2018 Jul-Aug;12(4):344-349. doi: 10.1016/j.jcct.2018.04.008. Epub 2018 May 8.

Reference Type DERIVED
PMID: 29866619 (View on PubMed)

Ko BS, Wong DT, Norgaard BL, Leong DP, Cameron JD, Gaur S, Marwan M, Achenbach S, Kuribayashi S, Kimura T, Meredith IT, Seneviratne SK. Diagnostic Performance of Transluminal Attenuation Gradient and Noninvasive Fractional Flow Reserve Derived from 320-Detector Row CT Angiography to Diagnose Hemodynamically Significant Coronary Stenosis: An NXT Substudy. Radiology. 2016 Apr;279(1):75-83. doi: 10.1148/radiol.2015150383. Epub 2015 Oct 6.

Reference Type DERIVED
PMID: 26444662 (View on PubMed)

Norgaard BL, Leipsic J, Gaur S, Seneviratne S, Ko BS, Ito H, Jensen JM, Mauri L, De Bruyne B, Bezerra H, Osawa K, Marwan M, Naber C, Erglis A, Park SJ, Christiansen EH, Kaltoft A, Lassen JF, Botker HE, Achenbach S; NXT Trial Study Group. Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease: the NXT trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps). J Am Coll Cardiol. 2014 Apr 1;63(12):1145-1155. doi: 10.1016/j.jacc.2013.11.043. Epub 2014 Jan 30.

Reference Type DERIVED
PMID: 24486266 (View on PubMed)

Gaur S, Achenbach S, Leipsic J, Mauri L, Bezerra HG, Jensen JM, Botker HE, Lassen JF, Norgaard BL. Rationale and design of the HeartFlowNXT (HeartFlow analysis of coronary blood flow using CT angiography: NeXt sTeps) study. J Cardiovasc Comput Tomogr. 2013 Sep-Oct;7(5):279-88. doi: 10.1016/j.jcct.2013.09.003. Epub 2013 Oct 1.

Reference Type DERIVED
PMID: 24268114 (View on PubMed)

Other Identifiers

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CP-902-001

Identifier Type: -

Identifier Source: org_study_id