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

NCT ID: NCT02939157

Last Updated: 2018-11-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 158 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-12
• Study Completion Date: 2017-12-30

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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Cardiac diagnostic ultrasound

Point-of-care ultrasound for diagnosing heart failure in primary care patients

Intervention Type: OTHER

Other Intervention Names

Point-of-care ultrasound

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gunnar Nilsson, MD;PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

References

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.

Reference Type: DERIVED

PMID: 31345207 (View on PubMed)

Other Identifiers

2016-02514

Identifier Type: -

Identifier Source: org_study_id