Heart Failure, CongestivePOCUSNCT02939157
Pocket-sized Ultrasound for Point-of-care Diagnosis of Heart Failure
An observational study of Heart Failure, Congestive and Cardiac Failure, run by Umeå University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure, Congestive, Cardiac Failure
- What is being tested?
- Cardiac diagnostic ultrasound
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- 12 Dec 2016to 30 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 250 adult study patients consulting to GPs in primary care for suspected cardiac failure.
Who may be able to join
None listed.
Who cannot join
- Non consenting patients.
- Patients in need of acute medical attention.
About this study
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.
Read the 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.
- Conditions
- Heart Failure, Congestive, Cardiac Failure
- Being tested
- Cardiac diagnostic ultrasound
- Keywords
- Diagnostic Ultrasound, Primary Care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac diagnostic ultrasoundOther
Also called Point-of-care ultrasound
Point-of-care ultrasound for diagnosing heart failure in primary care patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac failure
Detection of cardiac failure in patients consulting in primary care by a pocket sized ultrasound device, for use in primary care
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study start12 Dec 2016
- Primary completion15 Jun 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunnar Nilsson, MD;PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939157
- Sponsor's protocol ID
- 2016-02514
- Other IDs
- 2016
- Acronym
- POCUS
- Status last verified
- Sep 2016
- First submitted
- 20 Sep 2016
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nilsson G, Soderstrom L, Alverlind K, Samuelsson E, Mooe T. Hand-held cardiac ultrasound examinations performed in primary care patients by nonexperts to identify reduced ejection fraction. BMC Med Educ. 2019 Jul 25;19(1):282. doi: 10.1186/s12909-019-1713-9.
PubMed 31345207
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pocket-sized Ultrasound for Point-of-care Diagnosis of Heart Failure
- ClinicalTrials.gov ID
- NCT02939157
- Acronym / sponsor ID
- POCUS / 2016-02514
- Conditions
- Heart Failure, Congestive, Cardiac Failure
- Keywords
- Diagnostic Ultrasound, Primary Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 250 adult study patients consulting to GPs in primary care for suspected cardiac failure.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Non consenting patients.
- Patients in need of acute medical attention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac diagnostic ultrasoundAlso: Point-of-care ultrasoundPoint-of-care ultrasound for diagnosing heart failure in primary care patients | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Derived from this study: PubMed 31345207Nilsson G, Soderstrom L, Alverlind K, Samuelsson E, Mooe T. Hand-held cardiac ultrasound examinations performed in primary care patients by nonexperts to identify reduced ejection fraction. BMC Med Educ. 2019 Jul 25;19(1):282. doi: 10.1186/s12909-019-1713-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Nilsson, MD;PhD principal investigator
Umeå University
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Congestive and Cardiac Failure, run by Umeå University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02939157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.