Measurements and Characterization of Doppler Signals From the Right Chest in Pediatric and Adult Patients
NCT ID: NCT01913457
Last Updated: 2022-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
230 participants
OBSERVATIONAL
2013-07-31
2021-07-01
Brief Summary
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Pulmonary arterial hypertension (PAH) is a condition characterized by reshaping of the small pulmonary arteries with increase in pulmonary vascular resistance, leading gradually to right-sided cardiac failure. A trans-thoracic echocardiograph (TTE) is a test classically undertaken in order to screen for pulmonary hypertension. However, the systolic pulmonary artery pressure (SPAP) values thereby obtained are often imprecise and depend upon the expertise of the individual carrying out the test. Therefore, the pulmonary arterial pressure and cardiac output values have to be ascertained with a right-sided cardiac catheterization, which is considered the gold-standard, but is invasive.
In a pilot study of adult PAH patients (unpublished), lung Doppler signals have been shown to have the potential to diagnose pulmonary hypertension in two different ways: First, by measuring the degree of attenuation of the LDS during acute pressure rise in the chest cavity (i.e. during Valsalva maneuver). Second, by detecting differences between the LDS in patients with PAH and control subjects.
One of the objectives of the present study is to evaluate the lung Doppler signals in pediatric patients of various age groups, with and without pulmonary vascular disease. The second objective of the study is to verify previous findings of abnormal lung Doppler signals in adult patients with pulmonary hypertension.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adults w/ PH
Subjects above 18y scheduled to undergo RHC for Doppler ultrasound external right chest wall tests
Ultrasound Doppler
Doppler Ultrasound recording on external right chest wall
Children w/ PH
Children 0-18y old scheduled to RHC
Ultrasound Doppler
Doppler Ultrasound recording on external right chest wall
Children control
Children 0-18y old w/o PH for Lung Doppler tests as controls
Ultrasound Doppler
Doppler Ultrasound recording on external right chest wall
Interventions
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Ultrasound Doppler
Doppler Ultrasound recording on external right chest wall
Eligibility Criteria
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Inclusion Criteria
* Males or females aged over 18 years
* With suspicion or diagnosis of pulmonary hypertension.
* Scheduled to undergo right heart catheterization
* Able and willing to give informed consent
Pediatric patients undergoing RHC:
* Males or females aged 0-18 years
* Scheduled to undergo right hear catheterization
* Parents willing to give informed consent
Pediatric patients without significant cardio-pulmonary diseases:
* Males or females aged 0-18 years Not known to have a significant cardiac or pulmonary disease
* Legal guardians willing to give informed consent
Exclusion Criteria
* For adult and pediatric patients undergoing right heart catheterization:
a. Any contra-indication to perform the procedure
* For adults only:
1. Patients incapable of performing a Valsalva maneuver
2. Patients with recent (within the past 3 months) myocardial infarction, high degree AV block, severe aortic stenosis or open angle glaucoma
ALL
Yes
Sponsors
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Echosense Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffery Feinstein, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford Hospital and Clinics and Lucile Packard Children's Hospital
Locations
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Stanford Hospital and Clinics and Lucile Packard Children's Hospital
Palo Alto, California, United States
Stanford university hospital
Palo Alto, California, United States
Countries
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Other Identifiers
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DOP018/25388
Identifier Type: -
Identifier Source: org_study_id
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