Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05343091
Status:
UNKNOWN
Last Update Posted:
2022-05-27
First Post:
2022-04-18
Brief Title:
Prognostic Value of the Right Ventricular Function by Portable Ultrasound in Patients With Pulmonary Hypertension
Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Organization:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Overview
Official Title:
Prognostic Value of the Evaluation of Right Ventricular Function by Portable Ultrasound in Patients With Pulmonary Hypertension
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
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:
Pulmonary arterial hypertension PAH is a disease characterized by obliteration and remodeling of small-caliber pulmonary arteries progressively generating an increase in pulmonary vascular resistance right heart failure and death Current guidelines recommend a multidimensional approach which includes clinical echocardiographic exercise and hemodynamic variables to classify patients by risk and thus define a prognosis and guide therapeutic decisions
There is a wide range of studies which have shown a good correlation between standard echocardiography and portable cardiac ultrasound There is no doubt about the usefulness of portable cardiac ultrasound in the intensive care unit emergency department and even during hospital rounds however its usefulness during the daily examination in a follow-up consultation of patients at high risk of cardiovascular deterioration such as patients with PAH has not yet been demonstrated
There is evidence that a TAPSE measurement 17mm using standard echocardiography by a physician experienced in echocardiography predicts survival in patients with Pulmonary hypertension We would like to know if patients with low TAPSE will have a higher proportion of morbidity events compared to patients with normal TAPSE measured by portable ultrasound
There is a wide range of studies which have shown a good correlation between standard echocardiography and portable cardiac ultrasound There is no doubt about the usefulness of portable cardiac ultrasound in the intensive care unit emergency department and even during hospital rounds however its usefulness during the daily examination in a follow-up consultation of patients at high risk of cardiovascular deterioration such as patients with PAH has not yet been demonstrated
There is evidence that a TAPSE measurement 17mm using standard echocardiography by a physician experienced in echocardiography predicts survival in patients with Pulmonary hypertension We would like to know if patients with low TAPSE will have a higher proportion of morbidity events compared to patients with normal TAPSE measured by portable ultrasound
Detailed Description:
Pulmonary arterial hypertension PAH is a disease characterized by obliteration and remodeling of small-caliber pulmonary arteries progressively generating an increase in pulmonary vascular resistance right heart failure and death Current guidelines recommend a multidimensional approach which includes clinical echocardiographic exercise and hemodynamic variables to classify patients by risk and thus define a prognosis and guide therapeutic decisions
Transthoracic Echocardiography TTE currently plays an important role in the diagnostic algorithm of PAH as it is minimally invasive and readily available Moreover many echocardiographic parameters are closely related to pulmonary hemodynamics Some TTE parameters are associated with mortality and surviving in these patients such as shortening fraction presence of pericardial effusion eccentricity index systolic displacement of the tricuspid annular plane TAPSE size of the right atrium and right ventricular free wall strain
Ultrasound US is the only method which enables realtime bedside imaging of the heart Focused cardiac US provides worthy diagnostic information useful for the the clinical management of critical care patients The use of cardiac ultrasound in the last decade has gradually increased among non cardiologists Pocket ultrasounds are part of the third generation of ultrasounds described in the literature These have the characteristic of being light devices weighing less than 1kg and that can be carried in the pocket of the medical uniform This leads many researchers to believe that in the not too distant future its use will be part of the physical examination routine as the stethoscope is now
There is a wide range of studies which have shown a good correlation between standard echocardiography and portable cardiac ultrasound There is no doubt about the usefulness of portable cardiac ultrasound in the intensive care unit emergency department and even during hospital rounds however its usefulness during the daily examination in a follow-up consultation of patients at high risk of cardiovascular deterioration such as patients with PAH has not yet been demonstrated
STATEMENT OF THE PROBLEM Does the measurement of tricuspid annular plane systolic displacement TAPSE by portable cardiac ultrasound have prognostic utility in the follow-up of patients with Pulmonary Hypertension
JUSTIFICATION There is evidence that a TAPSE measurement 17mm using standard echocardiography by a physician experienced in echocardiography predicts survival in patients with Pulmonary hypertension However the high costs of an apparatus to perform the standard echocardiogram study and the prolonged appointments to perform the study delay the diagnosis of treatment of progression of cardiovascular disease Therefore it is important to document the usefulness of using an accessible medical tool during the cardiopulmonology consultation for the follow-up of patients with pulmonary hypertension
HYPOTHESIS Patients with low TAPSE will have a higher proportion of morbidity events compared to patients with normal TAPSE
Transthoracic Echocardiography TTE currently plays an important role in the diagnostic algorithm of PAH as it is minimally invasive and readily available Moreover many echocardiographic parameters are closely related to pulmonary hemodynamics Some TTE parameters are associated with mortality and surviving in these patients such as shortening fraction presence of pericardial effusion eccentricity index systolic displacement of the tricuspid annular plane TAPSE size of the right atrium and right ventricular free wall strain
Ultrasound US is the only method which enables realtime bedside imaging of the heart Focused cardiac US provides worthy diagnostic information useful for the the clinical management of critical care patients The use of cardiac ultrasound in the last decade has gradually increased among non cardiologists Pocket ultrasounds are part of the third generation of ultrasounds described in the literature These have the characteristic of being light devices weighing less than 1kg and that can be carried in the pocket of the medical uniform This leads many researchers to believe that in the not too distant future its use will be part of the physical examination routine as the stethoscope is now
There is a wide range of studies which have shown a good correlation between standard echocardiography and portable cardiac ultrasound There is no doubt about the usefulness of portable cardiac ultrasound in the intensive care unit emergency department and even during hospital rounds however its usefulness during the daily examination in a follow-up consultation of patients at high risk of cardiovascular deterioration such as patients with PAH has not yet been demonstrated
STATEMENT OF THE PROBLEM Does the measurement of tricuspid annular plane systolic displacement TAPSE by portable cardiac ultrasound have prognostic utility in the follow-up of patients with Pulmonary Hypertension
JUSTIFICATION There is evidence that a TAPSE measurement 17mm using standard echocardiography by a physician experienced in echocardiography predicts survival in patients with Pulmonary hypertension However the high costs of an apparatus to perform the standard echocardiogram study and the prolonged appointments to perform the study delay the diagnosis of treatment of progression of cardiovascular disease Therefore it is important to document the usefulness of using an accessible medical tool during the cardiopulmonology consultation for the follow-up of patients with pulmonary hypertension
HYPOTHESIS Patients with low TAPSE will have a higher proportion of morbidity events compared to patients with normal TAPSE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None