Pocket-sized Ultrasound for Point-of-care Diagnosis of He... | NCT02939157

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

NCT02939157

Sponsor

Umeå University

Status

Completed

Last Update Posted

Nov 29, 2018Actual

Enrollment

158Actual

Phase

Not provided

Conditions

Heart Failure, Congestive
Cardiac Failure

Interventions

Cardiac diagnostic ultrasound

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2016Actual

Primary Completion Date

Jun 15, 2017Actual

Completion Date

Dec 30, 2017Actual

First Submitted Date

Sep 20, 2016

First Submission Date that Met QC Criteria

Oct 17, 2016

First Posted Date

Oct 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2018

Last Update Posted Date

Nov 29, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

158Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac diagnostic ultrasound	Other	Point-of-care ultrasound for diagnosing heart failure in primary care patients		Point-of-care ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiac failure	Detection of cardiac failure in patients consulting in primary care by a pocket sized ultrasound device, for use in primary care	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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

250 adult study patients consulting to GPs in primary care for suspected cardiac failure.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gunnar Nilsson, MD;PhD	Umeå University	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31345207	Derived	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.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases