Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    29048522 [PUBMED-IDS]

Novel Methods for Arrhythmia Detection: Preliminary Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03721601
Recruitment Status : Completed
First Posted : October 26, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Kuopio University Hospital

Brief Summary:

Approximately 20-25% of strokes are of cardioembolic origin, atrial fibrillation (AF) being a significant cause of cardioembolic strokes. AF is often symptomless and intermittent, making its detection a clinical challenge. Currently the golden standard for diagnosis of AF is by 12-lead electrocardiogram (ECG) or any other ECG-strip.

The aim of the study is to assess the potential of chest strap as an ECG monitor, especially in arrhythmia detection by cardiologist and algorithm.


Condition or disease Intervention/treatment
Stroke Atrial Fibrillation Device: Heart rate monitor chest strap Device: Wrist band photoplethysmography

  Show Detailed Description

Layout table for study information
Study Type : Observational
Actual Enrollment : 220 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Novel Methods for Arrhythmia Detection: Chest Strap ECG and Wrist Band Photoplethysmography Compared to Holter-device for Atrial Fibrillation Detection
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Atrial fibrillation
Patients in atrial fibrillation as recorded by 3-lead Holter.
Device: Heart rate monitor chest strap
Simultaneously with 5min Holter recording, 5min recording of chest strap ECG.

Device: Wrist band photoplethysmography
Simultaneously with 5min Holter recording, 5min recording wrist band photoplethysmography.

Sinus rhythm
Patients in sinus rhythm as recorded by 3-lead Holter.
Device: Heart rate monitor chest strap
Simultaneously with 5min Holter recording, 5min recording of chest strap ECG.

Device: Wrist band photoplethysmography
Simultaneously with 5min Holter recording, 5min recording wrist band photoplethysmography.




Primary Outcome Measures :
  1. Chest strap and PPG-device data quality [ Time Frame: 5 minutes ]
    Sensitivity and positive predictive value for the beat detection of chest strap ECG and PPG measurements and sensitivity and specificity for the atrial fibrillation detection


Secondary Outcome Measures :
  1. Chest strap and PPG-device data quality to enable arrhythmia diagnosis [ Time Frame: 5 minutes ]
    Sensitivity and Specificity for the atrial fibrillation detection of chest strap ECG and PPG measurements.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients in internal medicine emergency department, cardiology ward, cardiology examination unit
Criteria

Inclusion Criteria:

  • Atrial fibrillation in 12-lead ECG

Exclusion Criteria:

  • body mass index (BMI) over 33
  • implanted pacemaker device
  • 12-lead ECG findings of left bundle branch block (LBBB) or right bundle branch block (RBBB)
  • medical condition requiring immediate treatment that would be delayed by the study measurements
  • serious infectious disease

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): NCT03721601


Locations
Layout table for location information
Finland
Helsinki University hospital
Helsinki, Finland, 00029
North Carelia central hospital
Joensuu, Finland, 80210
Kuopio University Hospital
Kuopio, Finland, 70029
Sponsors and Collaborators
Kuopio University Hospital
Investigators
Layout table for investigator information
Study Director: Tero Martikainen, MD, PhD Kuopio University Hospital

Publications:
Freedman B, Camm J, Calkins H, Healey JS, Rosenqvist M, Wang J, Albert CM, Anderson CS, Antoniou S, Benjamin EJ, Boriani G, Brachmann J, Brandes A, Chao TF, Conen D, Engdahl J, Fauchier L, Fitzmaurice DA, Friberg L, Gersh BJ, Gladstone DJ, Glotzer TV, Gwynne K, Hankey GJ, Harbison J, Hillis GS, Hills MT, Kamel H, Kirchhof P, Kowey PR, Krieger D, Lee VWY, Levin LÅ, Lip GYH, Lobban T, Lowres N, Mairesse GH, Martinez C, Neubeck L, Orchard J, Piccini JP, Poppe K, Potpara TS, Puererfellner H, Rienstra M, Sandhu RK, Schnabel RB, Siu CW, Steinhubl S, Svendsen JH, Svennberg E, Themistoclakis S, Tieleman RG, Turakhia MP, Tveit A, Uittenbogaart SB, Van Gelder IC, Verma A, Wachter R, Yan BP; AF-Screen Collaborators. Screening for Atrial Fibrillation: A Report of the AF-SCREEN International Collaboration. Circulation. 2017 May 9;135(19):1851-1867. doi: 10.1161/CIRCULATIONAHA.116.026693. Review.

Layout table for additonal information
Responsible Party: Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT03721601     History of Changes
Other Study ID Numbers: KUH507E015
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kuopio University Hospital:
atrial fibrillation
stroke
atrial fibrillation screening
heart rate monitoring

Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes