- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03876509
Non-invasive Diagnosis of Pulmonary Hypertension by Impedance Cardiography
Non-invasive Diagnosis of Pulmonary Hypertension by Thoracic Impedance Cardiography - a Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Steiermark
-
Graz, Steiermark, Austria, 8036
- Medical University Graz, Division of Pulmonology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Written Informed Consent
- Patients with clinical indication for right heart catheterization
Exclusion Criteria:
- known Pregnancy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Impedance Cardiography
|
Impedance Cardiography will be conducted in patients with suspected Pulmonary Hypertension within an interval of 24 hours to right-heart catheterization. Usually, 8 electrodes will be attached on the neck and thorax of the patient. These electrodes will produce current (max 400µA) and measure the voltage which is produced by the current running through the body. The Signal will be analyzed for specific signs of Pulmonary Hypertension. At the same time electrocardiography and non-invasive continuous blood pressure will be measured. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnosis of pulmonary hypertension
Time Frame: 1 hour
|
The sensitivity and specificity of Impedance Cardiography in the diagnosis of pulmonary Hypertension (as compared with the Gold Standard right heart catheterization) will be determined.
|
1 hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29-478 ex 16/17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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