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

NCT01757678 | Completed Results

• 1 other identifier: CP-902-001
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease Computed Fractional Flow Reserve

Outcome Measures

Primary Outcomes (1)

• AUC of FFRct Versus Coronary CTA for Demonstration of Ischemia (≤0.80) on a Per-patient Basis

  The primary statistical measure will be the area under the receiver operating characteristic curve (AUC of ROC) of a patient-based model to detect hemodynamically significant obstruction. ROC graphs the change in sensitivity as the cut-point for positive/negative diagnosis moves from its lower to upper limit. FFR is used as the reference standard to determine the presence or absence of hemodynamic obstruction. For FFR, hemodynamically-significant obstruction of a coronary artery is defined as an FFR≤0.80 in any major epicardial coronary artery segment with diameter ≥2.0 mm during adenosine-mediated hyperemia. For cCTA, hemodynamically-significant obstruction of a coronary artery is defined as a stenosis \>50% . FFRCT will be calculated for each patient as the minimum FFRCT in any coronary artery segment . cCTA stenosis will be calculated for each patient as the highest cCTA stenosis category for any vessel all measurements will take place only in segments with diameter ≥2.0 mm.

  1 day; Outcome measures were comparing FFRct to FFR. Incident time for FFR was dependent on the length of time on the cath procedure. FFRct was done remotely at HeartFlow's processing center in Redwood City with a turnaround time of 24 hours from CT scan.

Secondary Outcomes (3)

• AUC of FFRct Versus Coronary CTA for Demonstration of Ischemia (≤0.80) on a Per-vessel Basis

  1 day

• Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA

  1 day; Outcome measures were comparing FFRct to FFR. Incident time for FFR was dependent on the length of time on the cath procedure. FFRct was done remotely at HeartFlow's processing center in Redwood City with a turnaround time of 24 hours from CT scan.

• Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA

  1 day; Outcome measures were comparing FFRct to FFR. Incident time for FFR was dependent on the length of time on the cath procedure. FFRct was done remotely at HeartFlow's processing center in Redwood City with a turnaround time of 24 hours from CT scan.

Study Arms (1)

Standard of care: FFR, ICA, cCTA, FFRct

OTHER

(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)

Procedure: ICA (Invasive Coronary Angiography); Procedure: FFR (Fractional Flow Reserve); Procedure: cCTA (coronary computed tomography angiography); Other: FFRct Analysis (Fractional Flow Reserve Computed Tomography)

Interventions

ICA (Invasive Coronary Angiography) PROCEDURE

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

Standard of care: FFR, ICA, cCTA, FFRct

FFR (Fractional Flow Reserve) PROCEDURE

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

Standard of care: FFR, ICA, cCTA, FFRct

cCTA (coronary computed tomography angiography) PROCEDURE

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

Standard of care: FFR, ICA, cCTA, FFRct

FFRct Analysis (Fractional Flow Reserve Computed Tomography) OTHER

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

Standard of care: FFR, ICA, cCTA, FFRct

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HeartFlow, Inc.: lead
• Case Western Reserve University: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, Denmark

Location

Related Publications (5)

• 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.

  PMID: 31184558 DERIVED

• 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.

  PMID: 29866619 DERIVED

• 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.

  PMID: 26444662 DERIVED

• 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.

  PMID: 24486266 DERIVED

• 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.

  PMID: 24268114 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

13% of patients were judged to have nonevaluable cCTA images on the basis of a pre-defined image quality score. This number may be reduced with improvement of CT acquisition techniques as well a refinement of the FFRct technology.

Results Point of Contact

• Title: VP Clinical, Quality & Regulatory Affairs
• Organization: HeartFlow

clinicalresearch@heartflow.com

650-241-1221

Study Officials

• Bjarne Norgaard, MD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Masking Details: No Masking
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 31, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 14, 2017
• Results First Posted: November 14, 2017

Record last verified: 2017-11

Locations

DK (1)