Ignite Creation Date:
2024-05-06 @ 8:41 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02790918
Status:
COMPLETED
Last Update Posted:
2020-08-04
First Post:
2016-05-30
Brief Title:
Diagnosis of Pulmonary Hypertension Using Cardiac Magnetic Resonance Images
Sponsor:
National Heart Centre Singapore
Organization:
National Heart Centre Singapore
Study Overview
Official Title:
Noninvasive Diagnosis of Pulmonary Hypertension Using Three-dimensional Interventricular Septal Curvedness From Cardiac Magnetic Resonance Images
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study study team aim to i evaluate the accuracy of 3D IVS curvedness for prediction of RV systolic pressure RVSP mean pulmonary artery pressure mPAP and pulmonary vascular resistance PVR with RHC ii evaluate the usefulness of 3D IVS curvedness for predicting the response to vasodilator challenge with RHC in patients clinically suspected or known to have primary PH
Detailed Description:
1 Pulmonary hypertension Pulmonary hypertension PH is manifested as an increase in mean pulmonary artery pressure ie mPAP 25 mmHg at rest on right heart catheterization RHC Badesch 2009 It is a complex and multidisciplinary disorder causing restricted flow through the pulmonary arterial circulation due to increased pulmonary vascular resistance PVR It can be classified into five groups Simonneau et al 2004 Group I - Idiopathic PAH Familial PAH and PAH associated with collagen vascular disease et al Group II - PH with left heart disease Group III - PH associated with lung diseases andor hypoxemia Group IV - PH due to chronic thrombotic andor embolic disease and Group V - miscellaneous causes of PH The prognosis of PH is poor The National Institutes of Health NIH Registry followed 194 patients with IPAH enrolled at 32 clinical centers from 1981 to 1985 DAlonzo et al 1991 The reported median survival rates of 68 48 and 34 Similar results have been reported in Japan India and Mexico
Right heart catheterization RHC is the current reference standard for diagnosing PH Galie et al 2009 McLaughlin et al 2009 according to ACCFAHA expert consensus McLaughlin et al 2009 and ESCERS guidelines Galie et al 2009 Three hemodynamic measurements are essential from RHC right ventricular systolic pressure RVSP mean pulmonary artery pressure mPAP and pulmonary vascular resistance PVR Further patients with PH undergo RHC to assess clinical response to vasodilator challenge in order to guide therapy It helps identify patients with better prognosis and patients who could potentially benefit from treatment with calcium channel blockers A positive acute response is defined as a reduction of pulmonary artery pressure 10mmHg and 40mmHg Although RHC plays a pivotal role in PH diagnosis it is invasive and not without its own inherent risks Hoeper et al 2006 For these reasons development of a noninvasive alternative to RHC for diagnosis of PH is paramount
Noninvasive diagnosis of PH and prediction of response to vasodilator challenge is clinically needed
Several noninvasive methods for diagnosis of PH have been propounded the most common being Doppler echocardiography While routinely used to estimate pulmonary arterial pressure Doppler measurement of tricuspid regurgitation jet peak velocity has inherent limitations i the reliance on the visualization of the tricuspid regurgitant jet which is not always detectable ii the fact that peak velocity of the jet may be difficult to measure in the presence of severe tricuspid regurgitation and iii the need for adequate acoustic windows Hinderliter et al 2003 Hachulla et al 2005 Furthermore as recently emphasized in the ERSESC guideline Galie et al 2009 estimation of mPAP or PVR must be an integral part of a complete cardiac echocardiographic examination
It has long been recognized that systolic flattening and abnormal motion of the inter-ventricular septum IVS from either echocardiography King et al 1983 Reisner et al 1994 Ricciardi et al 1999 or cine CMR images Roeleveld et al 2005 Dellegrottaglie et al 2007 Alunni et al 2010 are signs of increased pulmonary arterial pressures However these studies are either qualitative or limited to 2D assessment relying for analysis on subjective selection of the imaging plane and cardiac cycle phase In the last 10 years despite advances in biomedical engineering and computational approaches no rigorous studies have been undertaken to study the relationship between quantitative 3D IVS shape and PH
It is well documented that RV dysfunction and the 6-min walk test 6MWT are associated with increased risk of mortality in PH van Wolfersen 2007 Study team has recently developed a new method for assessment of RV function in terms of area strain integrating radial circumferential and longitudinal deformation Zhong et al 2012 Therefore we will also investigate the relationship between RV area strain and exercise capacity in PH
Right heart catheterization RHC is the current reference standard for diagnosing PH Galie et al 2009 McLaughlin et al 2009 according to ACCFAHA expert consensus McLaughlin et al 2009 and ESCERS guidelines Galie et al 2009 Three hemodynamic measurements are essential from RHC right ventricular systolic pressure RVSP mean pulmonary artery pressure mPAP and pulmonary vascular resistance PVR Further patients with PH undergo RHC to assess clinical response to vasodilator challenge in order to guide therapy It helps identify patients with better prognosis and patients who could potentially benefit from treatment with calcium channel blockers A positive acute response is defined as a reduction of pulmonary artery pressure 10mmHg and 40mmHg Although RHC plays a pivotal role in PH diagnosis it is invasive and not without its own inherent risks Hoeper et al 2006 For these reasons development of a noninvasive alternative to RHC for diagnosis of PH is paramount
Noninvasive diagnosis of PH and prediction of response to vasodilator challenge is clinically needed
Several noninvasive methods for diagnosis of PH have been propounded the most common being Doppler echocardiography While routinely used to estimate pulmonary arterial pressure Doppler measurement of tricuspid regurgitation jet peak velocity has inherent limitations i the reliance on the visualization of the tricuspid regurgitant jet which is not always detectable ii the fact that peak velocity of the jet may be difficult to measure in the presence of severe tricuspid regurgitation and iii the need for adequate acoustic windows Hinderliter et al 2003 Hachulla et al 2005 Furthermore as recently emphasized in the ERSESC guideline Galie et al 2009 estimation of mPAP or PVR must be an integral part of a complete cardiac echocardiographic examination
It has long been recognized that systolic flattening and abnormal motion of the inter-ventricular septum IVS from either echocardiography King et al 1983 Reisner et al 1994 Ricciardi et al 1999 or cine CMR images Roeleveld et al 2005 Dellegrottaglie et al 2007 Alunni et al 2010 are signs of increased pulmonary arterial pressures However these studies are either qualitative or limited to 2D assessment relying for analysis on subjective selection of the imaging plane and cardiac cycle phase In the last 10 years despite advances in biomedical engineering and computational approaches no rigorous studies have been undertaken to study the relationship between quantitative 3D IVS shape and PH
It is well documented that RV dysfunction and the 6-min walk test 6MWT are associated with increased risk of mortality in PH van Wolfersen 2007 Study team has recently developed a new method for assessment of RV function in terms of area strain integrating radial circumferential and longitudinal deformation Zhong et al 2012 Therefore we will also investigate the relationship between RV area strain and exercise capacity in PH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None