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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 15 November 2021
Main ID:  NCT03547076
Date of registration: 24/05/2018
Prospective Registration: Yes
Primary sponsor: Helse Nord-Trøndelag HF
Public title: Handheld Ultrasound at Remote Locations
Scientific title: The Use of Handheld Ultrasound Utilizing Support by Experts or Automatic Analyses for Improved Diagnostics at Remote Locations
Date of first enrolment: June 6, 2018
Target sample size: 170
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03547076
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Sequential Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Norway
Contacts
Name:     Havard Dalen, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Norwegian University of Science and Tehnology
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients referred to the outpatient clinic at Levanger Hospital for echocardiography
due to suspicion of heart failure, which have consented to participate in the study.

- N-terminal pro brain natriuretic peptide (NT-proBNP) =125 ng/L or brain natriuretic
peptide =35 ng/L

Exclusion Criteria:

- The patient is not able to consent.

- The patient has know heart failure

- Known result of any of the following cardiac imaging tests (echocardiography, cardiac
magnet resonance imaging (MRI), cardiac (not coronary) computed tomography (CT).



Age minimum: 18 Years
Age maximum: 100 Years
Gender: All
Health Condition(s) or Problem(s) studied
Heart Failure
Intervention(s)
Diagnostic Test: Focused ultrasound diagnostics
Primary Outcome(s)
Clinical influence of diagnostic ultrasound examinations supported by telemedicine [Time Frame: Clinical influence will be tested on day 0 (time of study inclusion)]
Secondary Outcome(s)
Feasibility of handheld cardiac ultrasound performed by general practitioners [Time Frame: Feasibility will be tested on day 0 (time of study inclusion)]
Secondary ID(s)
LE-2018_GP1
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Levanger and Verdal Muncipality
Norwegian University of Science and Technology
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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