The Value of CT Fractional Flow Reserve

NCT03026283 | Completed Results DMC FDA Device

• 1 other identifier: 16-765-LHH
• Study Type: observational
• Target: 586
• Locations: 0 countries
• Sites: N/A

Brief Summary

Coronary Computed Tomography Angiogram (CCTA) is a non-invasive imaging modality that has high sensitivity and negative predictive value for the detection of coronary artery disease (CAD). The main limitations of CCTA are its poor specificity and positive predictive value, as well as its inherent lack of physiologically relevant data on hemodynamic significance of coronary stenosis, a data that is provided either by non-invasive stress tests such as myocardial perfusion imaging (MPI) or invasively by measurement of the Fractional Flow Reserve (FFR). Recent advances in computational fluid dynamic techniques applied to standard CCTA are now emerging as powerful tools for virtual measurement of FFR from CCTA imaging (CT-FFR). These techniques correlate well with invasively measured FFR \[1-4\]. The primary purpose of this study is to evaluate the incremental benefit CT-FFR as compared to CCTA in triaging chest pain patients in outpatient settings who are found to have obstructive CAD upon CCTA (\> 30% and \< 90% stenosis). Invasive FFR and short term clinical outcomes (90 days) will be correlated with each diagnostic modality in order to evaluate positive and negative predictive value of each when used incrementally with CCTA. This will be an observational trial in which patients will undergo a CCTA, as part of routine care. If the patient consents to participate in the study and is found to have coronary stenosis of 30% to 90%, based on the cardiologist's reading, the CCTA study will be sent to HeartFlow, a vendor that will provide a computerized FFR reading, based on the CCTA study. If the noninvasive FFR diagnosis indicates obstructive disease, the patient will be recommended to undergo cardiac catheterization with invasive FFR. As CCTA utilization increases, the need to train additional imaging specialists will increase. This study will assess the capability of FFR-CT to enhance performance on both negative and positive predictive value for less experienced readers by providing feedback based on CT-FFR evaluation. CCTA readers will be grouped in two categories: those with more than 10 years reading experience and those with less than 10 years reading experience. Each CCTA will be read by a less experienced and a more experienced reader. Results from each reader will be correlated with each other and with the CT-FFR and invasive FFR results.

Conditions

Angina, Stable Chest Pain

Outcome Measures

Primary Outcomes (1)

• Comparison of CCTA Alone to FFR-CT After CCTA

  To evaluate sensitivity, specificity, positive and negative predictive value for FFR-CT after CCTA vs. CCTA alone, using invasive FFR as the gold standard.

  Up to 1 year from the study initiation will be required to enroll all study patients and obstain invasive and noninvasive FFR.

Secondary Outcomes (6)

• Inter-observer Reliability: Assessment of All Cases

  Up to 1 year will be required to obtain all reader evaluations for the study in order to asses inter-observer reliability.

• Inter - Observer Reliability: Assessment of at Least Mild Disease (30% Stenosis or More)

  Up to 1 year will be required to obtain all reader evaluations for the study in order to asses inter-observer reliability.

• Inter - Observer Reliability: Assessment of at Least Moderate Disease (50% Stenosis or More on CCTA)

  Up to 1 year will be required to obtain all reader evaluations for the study in order to asses inter-observer reliability.

• Inter - Observer Reliability: Assessment of Severe Disease is Diagnosesed on Official Read (70% or Greater)

  Up to 1 year will be required to obtain all reader evaluations for the study in order to asses inter-observer reliability.

• Return Visits

  Up to 15 months will be required to collect 90 day follow up information on all study participants.

Study Arms (1)

1: HeartFlow CT-FFR Arm

All patients who consent will receive HeartFlow CT-FFR and medically acceptable care based on the study protocol, commonly accepted standards of care, and the patients condition.

Device: HeartFLow CT-FFR

Interventions

HeartFLow CT-FFR DEVICE

Patients receiving CCTA to diagnose stable chest pain or stable angina will receive CT-FFR to estimate rate of flow through the coronary arteries. The rate of flow will be compared to the rate found on Invasive FFR (the gold standard) if the subject receives invasive FFR.

Also known as: Noninvasive CT-FFR, FFR-CT, Noninvasive FFR-CT

1: HeartFlow CT-FFR Arm

Eligibility Criteria

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

Study Population

We reviewed a patient registry of 7,001 Stony Brook Medicine CCTA from 2011 to 2014,(work from our team members' prior research). About one third of the subjects were stable chest pain patients.

You may qualify if:

• Capable of giving informed consent.
• Able to cooperate with the technician performing the procedure.
• Patient must have Body Mass Index (BMI) \<= 50.
• Patients must have non-ST Elevation Myocardial Infarction (STEMI) Electrocardiogram (EKG) without acute changes.
• Patients must present to Research Institution with medically necessary appointment for CCTA for the purpose of evaluation of coronary stenosis for the provisional diagnoses of chest pain or angina or angina equivalent.
• Patients must be able to take nitroglycerin and beta blockers. -
• Patients must be 18 years of age or older.

You may not qualify if:

• Patients must not have a history of coronary stenting or coronary artery bypass graft.
• Patients must not have severe or end stage renal disease as diagnosed as estimated glomerular filtration rate (eGFR)\<50.
• Patients must not have a BMI\>50.

Sponsors & Collaborators

• Northwell Health: lead
• HeartFlow, Inc.: collaborator

Related Publications (10)

• Koo BK, Erglis A, Doh JH, Daniels DV, Jegere S, Kim HS, Dunning A, DeFrance T, Lansky A, Leipsic J, Min JK. Diagnosis of ischemia-causing coronary stenoses by noninvasive fractional flow reserve computed from coronary computed tomographic angiograms. Results from the prospective multicenter DISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional Flow Reserve) study. J Am Coll Cardiol. 2011 Nov 1;58(19):1989-97. doi: 10.1016/j.jacc.2011.06.066.

  PMID: 22032711 BACKGROUND

• 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.

  PMID: 22922562 BACKGROUND

• 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 BACKGROUND

• Liu HY, Chen JR, Hung HC, Hsiao SY, Huang ST, Chen HS. Urinary fluoride concentration in children with disabilities following long-term fluoride tablet ingestion. Res Dev Disabil. 2011 Nov-Dec;32(6):2441-8. doi: 10.1016/j.ridd.2011.07.016. Epub 2011 Aug 5.

  PMID: 21820860 BACKGROUND

• Niska R, Bhuiya F, Xu J. National Hospital Ambulatory Medical Care Survey: 2007 emergency department summary. Natl Health Stat Report. 2010 Aug 6;(26):1-31.

  PMID: 20726217 BACKGROUND

• Poon M, Cortegiano M, Abramowicz AJ, Hines M, Singer AJ, Henry MC, Viccellio P, Hellinger JC, Ferraro S, Poon A, Raff GL, Voros S, Farkouh ME, Noack P. Associations between routine coronary computed tomographic angiography and reduced unnecessary hospital admissions, length of stay, recidivism rates, and invasive coronary angiography in the emergency department triage of chest pain. J Am Coll Cardiol. 2013 Aug 6;62(6):543-52. doi: 10.1016/j.jacc.2013.04.040. Epub 2013 May 15.

  PMID: 23684682 BACKGROUND

• Budoff MJ, Dowe D, Jollis JG, Gitter M, Sutherland J, Halamert E, Scherer M, Bellinger R, Martin A, Benton R, Delago A, Min JK. Diagnostic performance of 64-multidetector row coronary computed tomographic angiography for evaluation of coronary artery stenosis in individuals without known coronary artery disease: results from the prospective multicenter ACCURACY (Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography) trial. J Am Coll Cardiol. 2008 Nov 18;52(21):1724-32. doi: 10.1016/j.jacc.2008.07.031.

  PMID: 19007693 BACKGROUND

• Meijboom WB, Meijs MF, Schuijf JD, Cramer MJ, Mollet NR, van Mieghem CA, Nieman K, van Werkhoven JM, Pundziute G, Weustink AC, de Vos AM, Pugliese F, Rensing B, Jukema JW, Bax JJ, Prokop M, Doevendans PA, Hunink MG, Krestin GP, de Feyter PJ. Diagnostic accuracy of 64-slice computed tomography coronary angiography: a prospective, multicenter, multivendor study. J Am Coll Cardiol. 2008 Dec 16;52(25):2135-44. doi: 10.1016/j.jacc.2008.08.058.

  PMID: 19095130 BACKGROUND

• Miller JM, Rochitte CE, Dewey M, Arbab-Zadeh A, Niinuma H, Gottlieb I, Paul N, Clouse ME, Shapiro EP, Hoe J, Lardo AC, Bush DE, de Roos A, Cox C, Brinker J, Lima JA. Diagnostic performance of coronary angiography by 64-row CT. N Engl J Med. 2008 Nov 27;359(22):2324-36. doi: 10.1056/NEJMoa0806576.

  PMID: 19038879 BACKGROUND

• Taylor AJ, Cerqueira M, Hodgson JM, Mark D, Min J, O'Gara P, Rubin GD; American College of Cardiology Foundation Appropriate Use Criteria Task Force; Society of Cardiovascular Computed Tomography; American College of Radiology; American Heart Association; American Society of Echocardiography; American Society of Nuclear Cardiology; North American Society for Cardiovascular Imaging; Society for Cardiovascular Angiography and Interventions; Society for Cardiovascular Magnetic Resonance; Kramer CM, Berman D, Brown A, Chaudhry FA, Cury RC, Desai MY, Einstein AJ, Gomes AS, Harrington R, Hoffmann U, Khare R, Lesser J, McGann C, Rosenberg A, Schwartz R, Shelton M, Smetana GW, Smith SC Jr. ACCF/SCCT/ACR/AHA/ASE/ASNC/NASCI/SCAI/SCMR 2010 appropriate use criteria for cardiac computed tomography. A report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, the Society of Cardiovascular Computed Tomography, the American College of Radiology, the American Heart Association, the American Society of Echocardiography, the American Society of Nuclear Cardiology, the North American Society for Cardiovascular Imaging, the Society for Cardiovascular Angiography and Interventions, and the Society for Cardiovascular Magnetic Resonance. J Am Coll Cardiol. 2010 Nov 23;56(22):1864-94. doi: 10.1016/j.jacc.2010.07.005.

  PMID: 21087721 BACKGROUND

Related Links

• NIH National heart, Lung and Blood Institute, What are the risks of cardiac catheterization

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This is an observational trial. The study team made recommendations to referring physicians after diagnostic work-up with CCTA and FFR-CT we performed. However, it was up to the referring physician as to whether to follow them.

Results Point of Contact

• Title: Pamela Noack
• Organization: Northwell Health

pnoack@northwell.edu

212 434 4926

Study Officials

• Michael Poon, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 20, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: May 30, 2023
• Results First Posted: June 5, 2020

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share