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

Sponsor
Umeå University (Other)
Overall Status
Completed
CT.gov ID
NCT02939157
Collaborator
(none)
158
12.6

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Dec 12, 2016
Actual Primary Completion Date :
Jun 15, 2017
Actual Study Completion Date :
Dec 30, 2017

Outcome Measures

Primary Outcome Measures

  1. Cardiac failure [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Umeå University

Investigators

  • Principal Investigator: Gunnar Nilsson, MD;PhD, Umeå University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Umeå University
ClinicalTrials.gov Identifier:
NCT02939157
Other Study ID Numbers:
  • 2016-02514
First Posted:
Oct 19, 2016
Last Update Posted:
Nov 29, 2018
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Umeå University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 29, 2018