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出境医 / 临床实验 / Validation of a Smartphone-based Recorder for Detection of Cardiac Arrhythmias
Validation of a Smartphone-based Recorder for Detection of Cardiac Arrhythmias
Study Description
Brief Summary:
The investigators will evaluate the diagnostic yield of the new AliveCor device versus a 12 lead ECG when used simultaneously to detect cardiac arrhythmia
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiac Arrhythmia | Device: Alivecor recording | Not Applicable |
Detailed Description:
The investigators are planning to record 250 pre-defined abnormal ECGs (50 each of atrial fibrillation, atrial flutter, pre-excitation, ventricular tachycardia, , supraventricular tachycardia) and 150 control ECGs (100 sinus rhythm, 50 sinus tachycardia) using both the AliveCor Smartphone device and a 12-lead ECG. All 400 ECGs will then be read by 3 blinded reporters - a Consultant Electrophysiologist, a Consultant General Cardiologist and a General Practitioner. The output of the AliveCor automatic detection algorithm will also be recorded as a fourth reporter. The screening characteristics of all 4 reporters using the AliveCor device vs the definitive 12 lead ECG will be analysed and compared.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 400 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Recordings with Alivecor and 12 lead ECGs with be acquired from patients with known arrhythmias/normal heart rhythm and blinded physicians will report on recordings and ECGs. Reports for each patient will be compared at the end of the study in order to assess diagnostic accuracy of the Alivecor to detect and differentiate between different kinds of abnormal heart rhythms. |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Diagnostic |
| Official Title: | Validation of a Smartphone-based Recorder for Detection of Cardiac Arrhythmias |
| Actual Study Start Date : | October 8, 2018 |
| Estimated Primary Completion Date : | October 7, 2020 |
| Estimated Study Completion Date : | October 7, 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Normal ECGs
Patients with normal ECGs
|
Device: Alivecor recording
Alivecor recording and ECG recording from the same patient in very close temporal proximity
|
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Active Comparator: Abnormal ECGs
Patients with different kinds of abnormal heart rhythms will be enrolled in order to compare whether Alivecor can accurately differentiate between these abnormal heart rhythms and normal sinus rhythm/sinus tachycardia. Also, Alivecor diagnostic accuracy in differentiating between different kinds of arrhythmias will be assessed.
|
Device: Alivecor recording
Alivecor recording and ECG recording from the same patient in very close temporal proximity
|
Outcome Measures
Primary Outcome Measures :
- Diagnostic accuracy of alivecor recording [ Time Frame: Diagnostic accuracy of Alivecor recording at the end of the study which will be 2 years after study start date. ]For each patient two diagnoses of their underlying heart rhythm will be provided by blinded reporters. The percentage match of these diagnoses (the ratio of identical diagnoses to mismatch in diagnoses between ECG report and Alivecor report will be used as a measure of accuracy of the Alivecor to differentiate between different heart rhythms, using the 12 lead ECG as the gold standard for cardiac rhythm diagnosis.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male or female patients >18 years
- 12 lead ECG finding of arrhythmia, manifest pre-excitation, pacing rhythm (in the EP lab), sinus rhythm or sinus tachycardia
Exclusion Criteria:
- Age <18 years
- Patients unable to or unwilling to use the device
- Patients with cardiac pacemaker, ICDs, or other implanted electronic devices
Contacts and Locations
Contacts
| Contact: Khalid Abozguia, Ph.D. | 00441253957780 | k.abozguia@nhs.net | |
| Contact: Dimitrios Katsaras, MD | 00441253957780 | d.katsaras@nhs.net |
Locations
| United Kingdom | |
| Blackpool Teaching Hospitals NHS Foundation Trust | Recruiting |
| Blackpool, Lancashire, United Kingdom, FY3 8NR | |
| Contact: Khalid Abozguia, PhD 00441253957780 k.abozguia@nhs.net | |
| Contact: Dimitrios Katsaras, MD 00441253957780 d.katsaras@nhs.net | |
Sponsors and Collaborators
Blackpool Teaching Hospitals NHS Foundation Trust
Investigators
| Principal Investigator: | Khalid Abozguia, Ph.D. | Blackpool Teaching Hospitals NHS Foundation Trust |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 28, 2019 | ||||||||
| First Posted Date ICMJE | June 25, 2019 | ||||||||
| Last Update Posted Date | September 16, 2020 | ||||||||
| Actual Study Start Date ICMJE | October 8, 2018 | ||||||||
| Estimated Primary Completion Date | October 7, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Diagnostic accuracy of alivecor recording [ Time Frame: Diagnostic accuracy of Alivecor recording at the end of the study which will be 2 years after study start date. ] For each patient two diagnoses of their underlying heart rhythm will be provided by blinded reporters. The percentage match of these diagnoses (the ratio of identical diagnoses to mismatch in diagnoses between ECG report and Alivecor report will be used as a measure of accuracy of the Alivecor to differentiate between different heart rhythms, using the 12 lead ECG as the gold standard for cardiac rhythm diagnosis.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Validation of a Smartphone-based Recorder for Detection of Cardiac Arrhythmias | ||||||||
| Official Title ICMJE | Validation of a Smartphone-based Recorder for Detection of Cardiac Arrhythmias | ||||||||
| Brief Summary | The investigators will evaluate the diagnostic yield of the new AliveCor device versus a 12 lead ECG when used simultaneously to detect cardiac arrhythmia | ||||||||
| Detailed Description | The investigators are planning to record 250 pre-defined abnormal ECGs (50 each of atrial fibrillation, atrial flutter, pre-excitation, ventricular tachycardia, , supraventricular tachycardia) and 150 control ECGs (100 sinus rhythm, 50 sinus tachycardia) using both the AliveCor Smartphone device and a 12-lead ECG. All 400 ECGs will then be read by 3 blinded reporters - a Consultant Electrophysiologist, a Consultant General Cardiologist and a General Practitioner. The output of the AliveCor automatic detection algorithm will also be recorded as a fourth reporter. The screening characteristics of all 4 reporters using the AliveCor device vs the definitive 12 lead ECG will be analysed and compared. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Intervention Model Description: Recordings with Alivecor and 12 lead ECGs with be acquired from patients with known arrhythmias/normal heart rhythm and blinded physicians will report on recordings and ECGs. Reports for each patient will be compared at the end of the study in order to assess diagnostic accuracy of the Alivecor to detect and differentiate between different kinds of abnormal heart rhythms. Masking: Single (Outcomes Assessor)Primary Purpose: Diagnostic |
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| Condition ICMJE | Cardiac Arrhythmia | ||||||||
| Intervention ICMJE | Device: Alivecor recording
Alivecor recording and ECG recording from the same patient in very close temporal proximity
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
400 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | October 7, 2020 | ||||||||
| Estimated Primary Completion Date | October 7, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United Kingdom | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03996954 | ||||||||
| Other Study ID Numbers ICMJE | IRAS Project ID:245687 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Dr. Khalid Abozguia, Blackpool Teaching Hospitals NHS Foundation Trust | ||||||||
| Study Sponsor ICMJE | Blackpool Teaching Hospitals NHS Foundation Trust | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Blackpool Teaching Hospitals NHS Foundation Trust | ||||||||
| Verification Date | September 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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