4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Evaluating Right Ventricular (RV) Size and Function Using the Upper Valley RV Algorithm and Novel Imaging Modalities (UVRV)

Evaluating Right Ventricular (RV) Size and Function Using the Upper Valley RV Algorithm and Novel Imaging Modalities (UVRV)

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Pulmonary Hypertension Valvular Heart Disease Congenital Heart Disease Congestive Heart Failure Pulmonary Embolism Acute Coronary Syndrome Diagnostic Test: Measuring Right Ventricular Size and Function

Detailed Description:

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.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Single-Center, Blinded, Randomized Control Trial Evaluating Different Approaches to Evaluation of Right Ventricular Size and Function Using the Upper Valley Right Ventricle Algorithm and Novel Imaging Modalities
Actual Study Start Date : August 5, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : August 2021
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Echocardiographic measurement - Right ventricular size [ Time Frame: Echocardiographic measurements are taken on the same day as the scheduled CMR, as close to the scheduled CMR as possible, approximately 1 hour ]
    De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies. Specific evaluating MRI derived right ventricular volumes versus various echo approaches to grading right ventricular size.

  2. Echocardiographic measurement - Right ventricular function [ Time Frame: Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour ]
    De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies.

  3. Echocardiographic measurement - Right ventricular dysfunction severity [ Time Frame: Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour ]
    De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies. Severity reported as mild, moderate or severe)


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date April 30, 2019
First Posted Date May 2, 2019
Last Update Posted Date October 9, 2020
Actual Study Start Date August 5, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 30, 2019)
  • Echocardiographic measurement - Right ventricular size [ Time Frame: Echocardiographic measurements are taken on the same day as the scheduled CMR, as close to the scheduled CMR as possible, approximately 1 hour ]
    De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies. Specific evaluating MRI derived right ventricular volumes versus various echo approaches to grading right ventricular size.
  • Echocardiographic measurement - Right ventricular function [ Time Frame: Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour ]
    De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies.
  • Echocardiographic measurement - Right ventricular dysfunction severity [ Time Frame: Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour ]
    De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies. Severity reported as mild, moderate or severe)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluating Right Ventricular (RV) Size and Function Using the Upper Valley RV Algorithm and Novel Imaging Modalities
Official Title A Single-Center, Blinded, Randomized Control Trial Evaluating Different Approaches to Evaluation of Right Ventricular Size and Function Using the Upper Valley Right Ventricle Algorithm and Novel Imaging Modalities
Brief Summary 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.
Detailed Description

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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This study is for people who are18-years or older that are undergoing cardiac magnetic resonance imaging (CMR) as a standard of care at Dartmouth-Hitchcock Medical Center in Lebanon, NH.
Condition
  • Pulmonary Hypertension
  • Valvular Heart Disease
  • Congenital Heart Disease
  • Congestive Heart Failure
  • Pulmonary Embolism
  • Acute Coronary Syndrome
Intervention Diagnostic Test: Measuring Right Ventricular Size and Function
This study focuses on evaluating different approaches to evaluation of right ventricular size and function using the Upper Valley Right Ventricle Algorithm and novel imaging modalities
Study Groups/Cohorts Not Provided
Publications *
  • 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.
  • Helbing WA. Right ventricular function: the comeback of echocardiography? Eur J Echocardiogr. 2004 Mar;5(2):99-101.
  • 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.
  • DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 30, 2019) 		50
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient age is over 18 years
  • Patient is undergoing Cardiac MRI with sequences that permit biventricular volumetric analysis
  • Patient is capable of giving informed consent
  • The cardiac MRI images are of diagnostic quality to provide accurate RV and LV volumes

Exclusion Criteria:

- Patient unable to under echocardiogram
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Allison J Hawke 603-650-7985 allison.j.hawke@hitchcock.org
Contact: Eric S Rothstein (603) 650-5724 Eric.S.Rothstein@hitchcock.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03935178
Other Study ID Numbers D19082 HVC 2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Individual participant echocardiographic data that underlie the results reported in all publications will be shared after deidentification (text, tables, figures and appendices). The informed consent and study plan will also be shared following publication of the study results.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Beginning 9 months and ending 36 months following article publication.
Access Criteria: Information will be made available to researchers who provide a methodologically sound proposal.
Responsible Party Eric S. Rothstein, Dartmouth-Hitchcock Medical Center
Study Sponsor Dartmouth-Hitchcock Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Scott Friedman, MD Dartmouth-Hitchcock Medical Center
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date October 2020

治疗医院

新药特效药

前沿医讯