Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05343091 |
| Other study ID # |
3492 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
January 31, 2023 |
Study information
| Verified date |
May 2022 |
| Source |
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| Contact |
Jose Luis Hernández Oropeza, Ph |
| Phone |
(55) 5487 0900 |
| Email |
elinternista[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
