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Pocket-sized Ultrasound for Point-of-care Diagnosis of Heart Failure (POCUS)

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ClinicalTrials.gov Identifier: NCT02939157
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Umeå University

Brief Summary:
Assessment of pocket sized ultrasound (Vscan GE Healthcare) for diagnosing heart failure in primary care patients, with a comprehensive cardiac ultrasound examination (Siemens Acusan P10) performed at a specialized the eco.lab, as reference.

Condition or disease Intervention/treatment
Heart Failure, Congestive Cardiac Failure Other: Cardiac diagnostic ultrasound

Detailed Description:
Waiting times for cardiac ultrasound is a cause of delay in identification of heart failure, which means delayed treatment, or that treatment recommendations are based on insufficient knowledge. Heart failure is a common condition; about 10% of 80-year-old people are affected and most patients are treated within primary care. A new ultrasound technology with integrated software support for interpretation (pocket-sized ultrasound) promises to improve care for heart patients and lead to earlier treatment with effective drugs. In cooperation with Norwegian researchers and the Region of Jämtland Härjedalen, this project opens opportunities for a significant medical innovation. The new concept, pocket-sized ultrasound for diagnosis of heart failure, has not previously been validated in patients seen in primary care. A new study may provide very important information that is directly applicable in the care of heart failure patients. We aim to recruit 250 study patients from the waiting list of patients referred from GPs, to ultrasound at the dpt. Of Clinical Physiology, Östersund Hospital, due to a suspicion of heart failure. The examinations will be carried out during the same day, with the investigators blinded to each other. The new concept of ultrasound has a potential to provide more cost-effective identification and monitoring of patients with heart failure in primary care.

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Study Type : Observational
Actual Enrollment : 158 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Pocket-sized Ultrasound for Point-of-care Diagnosis of Heart Failure
Actual Study Start Date : December 12, 2016
Actual Primary Completion Date : June 15, 2017
Actual Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Cardiac diagnostic ultrasound
    Point-of-care ultrasound for diagnosing heart failure in primary care patients
    Other Name: Point-of-care ultrasound


Primary Outcome Measures :
  1. Cardiac failure [ Time Frame: Assessment of cardiac failure by the study method (pocket sized ultrasound) is made on the same day as the reference method (comprehensive cardiac ultrasound), by independent investigators. ]
    Detection of cardiac failure in patients consulting in primary care by a pocket sized ultrasound device, for use in primary care



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
250 adult study patients consulting to GPs in primary care for suspected cardiac failure.
Criteria

Inclusion Criteria: Study patients fulfil all of the following criteria:

  1. Age 20 and over
  2. Recruited from primary care clinics, in the Region of Jämtland Härjedalen, Sweden.
  3. Referred to comprehensive cardiac ultrasound (reference method) from GPs, due to suspected heart failure.
  4. Provide written informed consent before enrolment.

Exclusion Criteria:

  1. Non consenting patients.
  2. Patients in need of acute medical attention.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939157


Sponsors and Collaborators
Umeå University
Investigators
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Principal Investigator: Gunnar Nilsson, MD;PhD Umeå University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT02939157     History of Changes
Other Study ID Numbers: 2016-02514
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Umeå University:
Diagnostic Ultrasound
Primary Care

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases