- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03935178
Evaluating Right Ventricular (RV) Size and Function Using the Upper Valley RV Algorithm and Novel Imaging Modalities (UVRV)
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
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
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New Hampshire
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Lebanon, New Hampshire, Yhdysvallat, 03756
- Dartmouth-Hitchcock Medical Center
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Echocardiographic measurement - Right ventricular size
Aikaikkuna: Echocardiographic measurements are taken on the same day as the scheduled CMR, as close to the scheduled CMR as possible, approximately 1 hour
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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.
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Echocardiographic measurements are taken on the same day as the scheduled CMR, as close to the scheduled CMR as possible, approximately 1 hour
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Echocardiographic measurement - Right ventricular function
Aikaikkuna: 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 measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour
|
Echocardiographic measurement - Right ventricular dysfunction severity
Aikaikkuna: 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)
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Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Scott Friedman, MD, Dartmouth-Hitchcock Medical Center
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
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- 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. doi: 10.1111/j.1540-8175.2007.00424.x.
- 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(Suppl 1):i19-26. doi: 10.1136/hrt.2005.082503. No abstract available.
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- 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. doi: 10.1016/s0735-1097(00)01089-5.
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- 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-Rande 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. doi: 10.1253/circj.cj-11-0778. 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.
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Sydänlihaksen iskemia
- Sydän-ja verisuonitaudit
- Verisuonisairaudet
- Hengityselinten sairaudet
- Keuhkosairaudet
- Synnynnäiset poikkeavuudet
- Embolia ja tromboosi
- Kardiovaskulaariset poikkeavuudet
- Hypertensio
- Sydämen vajaatoiminta
- Sydänsairaudet
- Embolia
- Hypertensio, keuhko
- Akuutti sepelvaltimo-oireyhtymä
- Sydänvika, synnynnäinen
- Sydänläppäsairaudet
- Keuhkoveritulppa
Muut tutkimustunnusnumerot
- D19082 HVC 2019
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
IPD-jaon aikakehys
IPD-jaon käyttöoikeuskriteerit
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- ICF
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