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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03935178
Recruitment Status Recruiting
First Posted May 2, 2019
Last update posted October 9, 2020
The primary purpose of this study is to evaluate the diagnostic performance of three methods for measuring right ventricular size and function including the Philips Novel RV quantification technologies (RV Heart Model volumetric analysis and Philips 2D strain) and the Upper Valley Right Ventricle Algorithm (UVRV) algorithm as compared to the gold standard of volumetric analysis via cardiac magnetic resonance imaging (CMR) in a broad patient population.
This is a single-center, blinded, randomized control trial of patients 18-years or older that are undergoing CMR as a standard of care at Dartmouth-Hitchcock Medical Center in Lebanon, NH. After informed consent is obtained, subjects undergo a study-specific external, non-invasive echocardiogram utilizing a special RV focused protocol on the same day of their CMR as close to their scheduled CMR as possible to minimize wait time for consented patients. The echocardiogram takes approximately an additional 30 minutes of the subject's time. De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three different methodologies (standard method, Phillips Novel technology and the newly developed UVRV algorithm). The methodologies will be compared with each other to determine sensitivity, specificity and accuracy.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Patient age is over 18 years
- Patient is undergoing Cardiac MRI with sequences that permit biventricular volumetric
- Patient is capable of giving informed consent
- The cardiac MRI images are of diagnostic quality to provide accurate RV and LV volumes
- Patient unable to under echocardiogram
Contact: Allison J Hawke 603-650-7985 email@example.com
Contact: Eric S Rothstein (603) 650-5724 Eric.S.Rothstein@hitchcock.org
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
Principal Investigator: Scott Friedman, MD Dartmouth-Hitchcock Medical Center
Graham TP Jr, Bernard YD, Mellen BG, Celermajer D, Baumgartner H, Cetta F, Connolly HM, Davidson WR, Dellborg M, Foster E, Gersony WM, Gessner IH, Hurwitz RA, Kaemmerer H, Kugler JD, Murphy DJ, Noonan JA, Morris C, Perloff JK, Sanders SP, Sutherland JL. Long-term outcome in congenitally corrected transposition of the great arteries: a multi-institutional study. J Am Coll Cardiol. 2000 Jul;36(1):255-61.
Chaowalit N, Durongpisitkul K, Krittayaphong R, Komoltri C, Jakrapanichakul D, Phrudprisan S. Echocardiography as a simple initial tool to assess right ventricular dimensions in patients with repaired tetralogy of Fallot before undergoing pulmonary valve replacement: comparison with cardiovascular magnetic resonance imaging. Echocardiography. 2012 Nov;29(10):1239-46. doi: 10.1111/j.1540-8175.2012.01766.x. Epub 2012 Jul 2.
Burgess MI, Mogulkoc N, Bright-Thomas RJ, Bishop P, Egan JJ, Ray SG. Comparison of echocardiographic markers of right ventricular function in determining prognosis in chronic pulmonary disease. J Am Soc Echocardiogr. 2002 Jun;15(6):633-9.
D'Alonzo GE, Barst RJ, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, Fishman AP, Goldring RM, Groves BM, Kernis JT, et al. Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med. 1991 Sep 1;115(5):343-9.
de Groote P, Millaire A, Foucher-Hossein C, Nugue O, Marchandise X, Ducloux G, Lablanche JM. Right ventricular ejection fraction is an independent predictor of survival in patients with moderate heart failure. J Am Coll Cardiol. 1998 Oct;32(4):948-54.
Dursunoğlu N, Dursunoğlu D, Yıldız Aİ, Rota S. Evaluation of cardiac biomarkers and right ventricular dysfunction in patients with acute pulmonary embolism. Anatol J Cardiol. 2016 Apr;16(4):276-82. doi: 10.5152/akd.2014.5828. Epub 2014 Dec 31.
Mehta SR, Eikelboom JW, Natarajan MK, Diaz R, Yi C, Gibbons RJ, Yusuf S. Impact of right ventricular involvement on mortality and morbidity in patients with inferior myocardial infarction. J Am Coll Cardiol. 2001 Jan;37(1):37-43.
Zehender M, Kasper W, Kauder E, Geibel A, Schönthaler M, Olschewski M, Just H. Eligibility for and benefit of thrombolytic therapy in inferior myocardial infarction: focus on the prognostic importance of right ventricular infarction. J Am Coll Cardiol. 1994 Aug;24(2):362-9.
Anavekar NS, Gerson D, Skali H, Kwong RY, Yucel EK, Solomon SD. Two-dimensional assessment of right ventricular function: an echocardiographic-MRI correlative study. Echocardiography. 2007 May;24(5):452-6.
Bleeker GB, Steendijk P, Holman ER, Yu CM, Breithardt OA, Kaandorp TA, Schalij MJ, van der Wall EE, Nihoyannopoulos P, Bax JJ. Assessing right ventricular function: the role of echocardiography and complementary technologies. Heart. 2006 Apr;92 Suppl 1:i19-26. Review.
Jorstig S, Waldenborg M, Lidén M, Thunberg P. Right ventricular ejection fraction measurements using two-dimensional transthoracic echocardiography by applying an ellipsoid model. Cardiovasc Ultrasound. 2017 Mar 7;15(1):4. doi: 10.1186/s12947-017-0096-5.
Zornoff LA, Skali H, Pfeffer MA, St John Sutton M, Rouleau JL, Lamas GA, Plappert T, Rouleau JR, Moyé LA, Lewis SJ, Braunwald E, Solomon SD; SAVE Investigators. Right ventricular dysfunction and risk of heart failure and mortality after myocardial infarction. J Am Coll Cardiol. 2002 May 1;39(9):1450-5.
Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010.
Kjaergaard J, Petersen CL, Kjaer A, Schaadt BK, Oh JK, Hassager C. Evaluation of right ventricular volume and function by 2D and 3D echocardiography compared to MRI. Eur J Echocardiogr. 2006 Dec;7(6):430-8. Epub 2005 Dec 9.
Pfluger HB, Maeder MT, LaGerche A, Taylor AJ. One- and two-dimensional estimation of right and left ventricular size and function-comparison with cardiac magnetic resonance imaging volumetric analysis. Heart Lung Circ. 2010 Sep;19(9):541-8. doi: 10.1016/j.hlc.2010.03.003. Epub 2010 Apr 24.
Ahmad H, Mor-Avi V, Lang RM, Nesser HJ, Weinert L, Tsang W, Steringer-Mascherbauer R, Niel J, Salgo IS, Sugeng L. Assessment of right ventricular function using echocardiographic speckle tracking of the tricuspid annular motion: comparison with cardiac magnetic resonance. Echocardiography. 2012;29(1):19-24. doi: 10.1111/j.1540-8175.2011.01519.x. Epub 2011 Oct 4.
Giusca S, Dambrauskaite V, Scheurwegs C, D'hooge J, Claus P, Herbots L, Magro M, Rademakers F, Meyns B, Delcroix M, Voigt JU. Deformation imaging describes right ventricular function better than longitudinal displacement of the tricuspid ring. Heart. 2010 Feb;96(4):281-8. doi: 10.1136/hrt.2009.171728. Epub 2009 Aug 30.
Guendouz S, Rappeneau S, Nahum J, Dubois-Randé JL, Gueret P, Monin JL, Lim P, Adnot S, Hittinger L, Damy T. Prognostic significance and normal values of 2D strain to assess right ventricular systolic function in chronic heart failure. Circ J. 2012;76(1):127-36. Epub 2011 Oct 27.
Hardegree EL, Sachdev A, Villarraga HR, Frantz RP, McGoon MD, Kushwaha SS, Hsiao JF, McCully RB, Oh JK, Pellikka PA, Kane GC. Role of serial quantitative assessment of right ventricular function by strain in pulmonary arterial hypertension. Am J Cardiol. 2013 Jan 1;111(1):143-8. doi: 10.1016/j.amjcard.2012.08.061. Epub 2012 Oct 23.
Maffessanti F, Gripari P, Tamborini G, Muratori M, Fusini L, Alamanni F, Zanobini M, Fiorentini C, Caiani EG, Pepi M. Evaluation of right ventricular systolic function after mitral valve repair: a two-dimensional Doppler, speckle-tracking, and three-dimensional echocardiographic study. J Am Soc Echocardiogr. 2012 Jul;25(7):701-8. doi: 10.1016/j.echo.2012.03.017. Epub 2012 Apr 25.
Shimada YJ, Shiota M, Siegel RJ, Shiota T. Accuracy of right ventricular volumes and function determined by three-dimensional echocardiography in comparison with magnetic resonance imaging: a meta-analysis study. J Am Soc Echocardiogr. 2010 Sep;23(9):943-53. doi: 10.1016/j.echo.2010.06.029.
Petersen SE, Aung N, Sanghvi MM, Zemrak F, Fung K, Paiva JM, Francis JM, Khanji MY, Lukaschuk E, Lee AM, Carapella V, Kim YJ, Leeson P, Piechnik SK, Neubauer S. Reference ranges for cardiac structure and function using cardiovascular magnetic resonance (CMR) in Caucasians from the UK Biobank population cohort. J Cardiovasc Magn Reson. 2017 Feb 3;19(1):18. doi: 10.1186/s12968-017-0327-9.