- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03683355
Characterization of RadiOlabeled Tracer Uptake Pattern in Noninfected Transcatheter Aortic Valves. (COUNT)
Characterization of Radiolabeled Tracer Uptake Pattern in Noninfected Transcatheter Aortic Valves. The COUNT Study. A Prospective, Observational Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Diagnostic accuracy of Infective endocarditis (IE) is commonly challenging. Current clinical guidelines recommend the use of the modified Duke criteria, based on clinical, echocardiographic and biological findings, as well as the results of blood cultures and serologies. Advances in imaging techniques have resulted in an improvement in the identification of endocardial involvements and extracardiac complications of IE. Thus, recent works have demonstrated that 18F-FDG PET/CT and radiolabeled leucocyte SPECT/CT may improve the detection of silent endocardial lesions. The sites of radiotracer accumulation show regions of a high metabolic activity due to an inflammation or infection process. It is well known that, in surgical prosthetic valves, a mild radiotracer uptake in the perivalvular area may occur in the absence of infection and could therefore be considered as a normal pattern, particularly early after valve replacement. However, evidence of this phenomenon is lacking regarding transcatheter heart valves and the factors used to distinguish between normal and abnormal patterns of radiolabeled tracer are not standardized. The hypothesis is that patients undergoing transcatheter aortic valve replacement (TAVR) show a radiolabeled tracer (18F-FDG) uptake around the prosthesis despite the absence of IE. Moreover, the uptake pattern might vary between different platforms.
Therefore, the objective of the study is to characterize the pattern of radiolabeled tracer uptake in noninfected transcatheter heart valves in early follow-up after TAVR.
This will be a pilot study including 30 patients after TAVR procedure.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Quebec, Canada, G1V 4G5
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients >18-year-old undergoing TAVR procedure with Edwards Sapien 3 and Core Valve Evolut R devices.
- Informed written consent
Exclusion Criteria:
- Inability to provide signed informed consent.
- Patients with definitive or possible IE according to modified Duke criteria and current clinical guidelines for the management of IE.
- Any contraindication for 18F-FDG PET/CT.
- Any condition making it unlikely the patient will be able to complete the protocol procedures and follow-up visits.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Edwards Sapien 3
Patients who underwent transcatheter aortic valve replacement with the Edwards Sapien 3 valve
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18F-FDG PET/CT and blood cultures will be performed at 3-month follow-up after TAVR Patients with positive 18F-FDG PET/CT (moderate or intense radiolabeled tracer uptake) will be scheduled for a second 18F-FDG PET/CT at 6-month follow-up.
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Core Valve Evolut R
Patients who underwent transcatheter aortic valve replacement with the Core Valve Evolut R valve
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18F-FDG PET/CT and blood cultures will be performed at 3-month follow-up after TAVR Patients with positive 18F-FDG PET/CT (moderate or intense radiolabeled tracer uptake) will be scheduled for a second 18F-FDG PET/CT at 6-month follow-up.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiolabeled tracer uptake grade (intense, moderate, mild or absent) in the prosthetic and periprosthetic areas.
Time Frame: 3 months after TAVR
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Visual analysis grading the radiolabeled tracer molecules uptake in the prosthetic and periprosthetic areas as intense, moderate, mild or absent.
This visual analysis will be defined whether the PET/CT was positive (intense/moderate) or negative (mild/absent).
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3 months after TAVR
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal standardized uptake value (SUVmax) using an average of 3 measurements from 3 volumes of interest (5mm3) introduced in the prosthetic region at equal distances from each other.
Time Frame: 3 months after TAVR
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The intensity of the radiolabeled tracer uptake will be determined by measuring the maximal standardized uptake value (SUVmax)), which is obtained by normalizing the tissue concentration of the radiolabeled tracer activity and the patient's weight.
SUVmax will be calculated using an average of 3 measurements from 3 volumes of interest (5mm3) introduced in the prosthetic region at equal distances from each other.
The prosthetic valve-to-background ratio will be calculated by dividing the prosthetic valve SUV max by the atrial blood SUVmax.
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3 months after TAVR
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Differences in radiolabeled tracer uptake grade in the prosthetic and periprosthetic areas between the Edwards valve versus the CoreValve valve.
Time Frame: 3 months after TAVR
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Differences in radiolabeled tracer uptake pattern with different valves: Edwards THV vs CoreValve THV
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3 months after TAVR
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Correlation between radiolabeled tracer uptake grade and time from TAVR
Time Frame: 3 months after TAVR
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Relationship between radiolabeled tracer uptake and time from the procedure
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3 months after TAVR
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Collaborators and Investigators
Publications and helpful links
General Publications
- Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
- Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Munoz D, Rosenhek R, Sjogren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017 Sep 21;38(36):2739-2791. doi: 10.1093/eurheartj/ehx391. No abstract available.
- Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.
- Vongpatanasin W, Hillis LD, Lange RA. Prosthetic heart valves. N Engl J Med. 1996 Aug 8;335(6):407-16. doi: 10.1056/NEJM199608083350607. No abstract available.
- Hoen B, Duval X. Clinical practice. Infective endocarditis. N Engl J Med. 2013 Apr 11;368(15):1425-33. doi: 10.1056/NEJMcp1206782. No abstract available. Erratum In: N Engl J Med. 2013 Jun 27;368(26):2536.
- Wang A, Pappas P, Anstrom KJ, Abrutyn E, Fowler VG Jr, Hoen B, Miro JM, Corey GR, Olaison L, Stafford JA, Mestres CA, Cabell CH; International Collaboration on Endocarditis Investigators. The use and effect of surgical therapy for prosthetic valve infective endocarditis: a propensity analysis of a multicenter, international cohort. Am Heart J. 2005 Nov;150(5):1086-91. doi: 10.1016/j.ahj.2005.01.023.
- Akowuah EF, Davies W, Oliver S, Stephens J, Riaz I, Zadik P, Cooper G. Prosthetic valve endocarditis: early and late outcome following medical or surgical treatment. Heart. 2003 Mar;89(3):269-72. doi: 10.1136/heart.89.3.269.
- Edwards MB, Ratnatunga CP, Dore CJ, Taylor KM. Thirty-day mortality and long-term survival following surgery for prosthetic endocarditis: a study from the UK heart valve registry. Eur J Cardiothorac Surg. 1998 Aug;14(2):156-64. doi: 10.1016/s1010-7940(98)00148-1.
- Tornos P, Almirante B, Olona M, Permanyer G, Gonzalez T, Carballo J, Pahissa A, Soler-Soler J. Clinical outcome and long-term prognosis of late prosthetic valve endocarditis: a 20-year experience. Clin Infect Dis. 1997 Mar;24(3):381-6. doi: 10.1093/clinids/24.3.381.
- Grover FL, Cohen DJ, Oprian C, Henderson WG, Sethi G, Hammermeister KE. Determinants of the occurrence of and survival from prosthetic valve endocarditis. Experience of the Veterans Affairs Cooperative Study on Valvular Heart Disease. J Thorac Cardiovasc Surg. 1994 Aug;108(2):207-14.
- Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.
- Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17.
- Regueiro A, Linke A, Latib A, Ihlemann N, Urena M, Walther T, Husser O, Herrmann HC, Nombela-Franco L, Cheema AN, Le Breton H, Stortecky S, Kapadia S, Bartorelli AL, Sinning JM, Amat-Santos I, Munoz-Garcia A, Lerakis S, Gutierrez-Ibanes E, Abdel-Wahab M, Tchetche D, Testa L, Eltchaninoff H, Livi U, Castillo JC, Jilaihawi H, Webb JG, Barbanti M, Kodali S, de Brito FS Jr, Ribeiro HB, Miceli A, Fiorina C, Dato GM, Rosato F, Serra V, Masson JB, Wijeysundera HC, Mangione JA, Ferreira MC, Lima VC, Carvalho LA, Abizaid A, Marino MA, Esteves V, Andrea JC, Giannini F, Messika-Zeitoun D, Himbert D, Kim WK, Pellegrini C, Auffret V, Nietlispach F, Pilgrim T, Durand E, Lisko J, Makkar RR, Lemos PA, Leon MB, Puri R, San Roman A, Vahanian A, Sondergaard L, Mangner N, Rodes-Cabau J. Association Between Transcatheter Aortic Valve Replacement and Subsequent Infective Endocarditis and In-Hospital Death. JAMA. 2016 Sep 13;316(10):1083-92. doi: 10.1001/jama.2016.12347.
- Habib G, Lancellotti P, Antunes MJ, Bongiorni MG, Casalta JP, Del Zotti F, Dulgheru R, El Khoury G, Erba PA, Iung B, Miro JM, Mulder BJ, Plonska-Gosciniak E, Price S, Roos-Hesselink J, Snygg-Martin U, Thuny F, Tornos Mas P, Vilacosta I, Zamorano JL; ESC Scientific Document Group. 2015 ESC Guidelines for the management of infective endocarditis: The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC). Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM). Eur Heart J. 2015 Nov 21;36(44):3075-3128. doi: 10.1093/eurheartj/ehv319. Epub 2015 Aug 29. No abstract available.
- Gomes A, Glaudemans AWJM, Touw DJ, van Melle JP, Willems TP, Maass AH, Natour E, Prakken NHJ, Borra RJH, van Geel PP, Slart RHJA, van Assen S, Sinha B. Diagnostic value of imaging in infective endocarditis: a systematic review. Lancet Infect Dis. 2017 Jan;17(1):e1-e14. doi: 10.1016/S1473-3099(16)30141-4. Epub 2016 Oct 18.
- Mathieu C, Mikail N, Benali K, Iung B, Duval X, Nataf P, Jondeau G, Hyafil F, Le Guludec D, Rouzet F. Characterization of 18F-Fluorodeoxyglucose Uptake Pattern in Noninfected Prosthetic Heart Valves. Circ Cardiovasc Imaging. 2017 Mar;10(3):e005585. doi: 10.1161/CIRCIMAGING.116.005585.
- Sarrazin JF, Philippon F, Trottier M, Tessier M. Role of radionuclide imaging for diagnosis of device and prosthetic valve infections. World J Cardiol. 2016 Sep 26;8(9):534-546. doi: 10.4330/wjc.v8.i9.534.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COUNT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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