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Efficacy of Snap on Symptomatic Arrhythmia

Primary Purpose

Arrhythmia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Snap
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arrhythmia focused on measuring Snap, symptomatic arrhythmia, diagnosis, follow-up

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • symptomatic arrhythmia

Exclusion Criteria:

  • can not use the Snap instrument and Sign informed consent

Sites / Locations

  • DynoRecruiting
  • the First Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Snap group

RC group

Arm Description

individuals in this arm used Snap according to the instruction on time and screened at the symptomatic

patients in the RC arm accepted normal methods

Outcomes

Primary Outcome Measures

Evaluating the ability of handheld device with remote interpretation to screen for arrhythmia
Participants in Snap group acquired ECG once od according to the rules and transmitted ECG immediately once symptom appeared between 3-month. Patients in the routine treatment (RT) group were administrated normal diagnostic techniques. At 3-month, compared the incidence atrial arrhythmia(atrial premature beats and atrial tachycardia) and ventricula arrhythmia(ventricular premature beats and ventricular tachycardia) between two groups.

Secondary Outcome Measures

Evaluating the patients' quality of life
Using RAND 36-Item Short Form Health Survey (SF-36) 1.0 Questionnaire items assessed the quality of life of participants. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate. The eight sections are: vitality, physical functioning, bodily pain, general, health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. The total scale ranges from 35 to 145. The higher the total score, the better the patient's quality of life.

Full Information

First Posted
December 7, 2017
Last Updated
July 24, 2020
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03396133
Brief Title
Efficacy of Snap on Symptomatic Arrhythmia
Official Title
Assessment of Portable Remote Health Monitor Using the Snap to Symptomatic Arrhythmia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Participants in the Snap arm were instructed to undertake once-day recording and transmission of a 30-second single-lead iECG trace to a secure server, plus additional submissions if symptomatic over a 3-month period. Snap traces were analyzed by an automated analysis software and cardiologists. Clinical review and appropriate care was arranged for those clinically significant arrhythmia. Patients in the RC group were followed up as normal methods including ECG, Holter.
Detailed Description
Individuals with symptomatic arrhythmia without known arrhythmia were recruited. Participants were required to have access to the internet via WiFi and to be able to operate the Snap system after simple instruction. Written consent was obtained, and eligible participants were randomized (1:1) to an intervention (Snap) group or RC group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
Keywords
Snap, symptomatic arrhythmia, diagnosis, follow-up

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Snap group
Arm Type
Experimental
Arm Description
individuals in this arm used Snap according to the instruction on time and screened at the symptomatic
Arm Title
RC group
Arm Type
No Intervention
Arm Description
patients in the RC arm accepted normal methods
Intervention Type
Diagnostic Test
Intervention Name(s)
Snap
Intervention Description
screen, transmission, and analysis ECG automated
Primary Outcome Measure Information:
Title
Evaluating the ability of handheld device with remote interpretation to screen for arrhythmia
Description
Participants in Snap group acquired ECG once od according to the rules and transmitted ECG immediately once symptom appeared between 3-month. Patients in the routine treatment (RT) group were administrated normal diagnostic techniques. At 3-month, compared the incidence atrial arrhythmia(atrial premature beats and atrial tachycardia) and ventricula arrhythmia(ventricular premature beats and ventricular tachycardia) between two groups.
Time Frame
3-month
Secondary Outcome Measure Information:
Title
Evaluating the patients' quality of life
Description
Using RAND 36-Item Short Form Health Survey (SF-36) 1.0 Questionnaire items assessed the quality of life of participants. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate. The eight sections are: vitality, physical functioning, bodily pain, general, health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. The total scale ranges from 35 to 145. The higher the total score, the better the patient's quality of life.
Time Frame
3-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: symptomatic arrhythmia Exclusion Criteria: can not use the Snap instrument and Sign informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Jian Li, PHD
Phone
13701465229
Ext
86
Email
lijay@njmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Shuang Li, MD
Phone
13773998967
Ext
86
Email
gd_l2000@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Jian Li, PHD
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jin-Shuang Li, MD
Organizational Affiliation
Suqian People's Hospital of Nanjing Drum Tower Hospital Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liang-Hong Ying, MD
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Dyno
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Shuang Li, MD
Phone
18751070788
Ext
86
Email
gd_l2000@163.com
Facility Name
the First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Shuang Li, MD
Phone
18751070788
Email
gd_l2000@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28851729
Citation
Halcox JPJ, Wareham K, Cardew A, Gilmore M, Barry JP, Phillips C, Gravenor MB. Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF Study. Circulation. 2017 Nov 7;136(19):1784-1794. doi: 10.1161/CIRCULATIONAHA.117.030583. Epub 2017 Aug 28.
Results Reference
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Efficacy of Snap on Symptomatic Arrhythmia

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