StrokeNCT03721601
Novel Methods for Arrhythmia Detection: Preliminary Study
An observational study of Stroke and Atrial Fibrillation, run by Kuopio University Hospital at 3 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Atrial Fibrillation
- What is being tested?
- Heart rate monitor chest strap and Wrist band photoplethysmography
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- 3 sitesFinland
- Study dates
- 1 May 2017to 30 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients in internal medicine emergency department, cardiology ward, cardiology examination unit
Who may be able to join
- Atrial fibrillation in 12-lead ECG
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Helsinki University hospital
Helsinki, 00029
North Carelia central hospital
Joensuu, 80210
Kuopio University Hospital
Kuopio, 70029
About this study
Official title: Novel Methods for Arrhythmia Detection: Chest Strap ECG and Wrist Band Photoplethysmography Compared to Holter-device for Atrial Fibrillation Detection
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.
Read the detailed description
Study design was a prospective case-control multicenter study at three sites in Finland. Study material was collected in internal medicine emergency departments, cardiology wards and cardiology examination units of participating hospitals, Kuopio University Hospital, Helsinki University Central Hospital, Meilahti and North Karelia Central Hospital, Joensuu. The study design was approved by University of Eastern Finland ethics committee (237/2017).
Study participants received a written information sheet about the study and were provided with an opportunity to ask questions concerning the study. A written informed consent was signed by the participants, including a permission to use patient's medical records.
Screening of study participants was made in participating hospitals from admitted patients in May - September 2017. The inclusion criteria for study group patients was atrial fibrillation confirmed by a doctor-interpreted 12-lead ECG, taken for medical reasons. Exclusion criteria were: 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. Control group consisted of patients with normal sinus rhythm in 12-lead ECG.
Demographics of study patients, including age, gender, previous medical history (as reported by patient or from patient medical records), length, weight and BMI, was recorded.
First, a 12-lead ECG was taken over a period of 10 seconds for rhythm confirmation, after which the ECG electrodes were removed. In the next step, altogether 5 wet electrodes were attached to patient to record ECG with Faros 360 Holter device (Mega Elektroniikka, Kuopio, Finland; device 1) to be used as golden standard for rhythm monitoring. Simultaneously a heart rate monitoring chest strap (Suunto Movesense, Suunto, Vantaa, Finland; device 2) and wrist band photoplethysmography (PPG) (Empatica E4, Empatica inc., Cambridge, United States) was applied. A total of 5 min recording was made.
The data from heart rate chest strap was sent via Bluetooth connection to a mobile phone, from which it was transferred via a cable to study computer; the data from Faros Holter device was recorded to device´s internal memory card and transferred to analyzing software. PPG data were transferred to MATLAB® software version R2017b for pre-processing and analysis. The data collected was anonymized and ECG data from chest strap and Holter device was analyzed using MATLAB software.
The quality of the ECG-strip was defined as good (no or only minor artefacts), average (artefacts but QRS and/or P-wave identifiable) or poor (major artefacts, no identifiable QRS and/or P-wave) by the cardiologist. The rhythm from the ECG-strips was divided to three categories: sinus rhythm (SR), atrial fibrillation (AF) or other/inconclusive. The cardiologists also assessed the possibility to detect P-waves from the ECG-strips with sinus rhythm (yes/no).
The study population consisted of total 220 patients. According to the initial 12-lead ECG, total 110 patients with atrial fibrillation were collected, and control group consisted of 110 patients with normal sinus rhythm. The initial 12-lead ECG was only used to recruitment process of patients; later the division to sinus rhythm, atrial fibrillation or other rhythm used in the final analysis was made according to the cardiologist-interpreted Holter ECG.
Two commonly used AF detection algorithms were used in this work. Algorithms were used to demonstrate possibilities of automatic screening of AF using chest strap ECG devices with automated analysis.
Holter ECG serving as golden standard a total of 218 patients were included and 2 were excluded in the analysis. 2 of 220 3-lead Holter ECGs could be classified neither as sinus rhythm nor atrial fibrillation. One of them converted from atrial flutter to sinus rhythm during analysis and the quality of other ECG was insufficient for rhythm analysis. These two Holter ECGs and the corresponding chest strap ECGs were excluded from final analysis.
- Conditions
- Stroke, Atrial Fibrillation
- Being tested
- Heart rate monitor chest strap, Wrist band photoplethysmography
- Keywords
- atrial fibrillation, stroke, atrial fibrillation screening, heart rate monitoring
- Medical subject headings
- Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate monitor chest strapDevice
Simultaneously with 5min Holter recording, 5min recording of chest strap ECG.
Wrist band photoplethysmographyDevice
Simultaneously with 5min Holter recording, 5min recording wrist band photoplethysmography.
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation | Patients in atrial fibrillation as recorded by 3-lead Holter. Receives: Device: Heart rate monitor chest strap; Device: Wrist band photoplethysmography | |
| Sinus rhythm | Patients in sinus rhythm as recorded by 3-lead Holter. Receives: Device: Heart rate monitor chest strap; Device: Wrist band photoplethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest strap and PPG-device data quality
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
Measured: 5 minutes
Secondary outcomes (1)
Chest strap and PPG-device data quality to enable arrhythmia diagnosis
Sensitivity and Specificity for the atrial fibrillation detection of chest strap ECG and PPG measurements.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start1 May 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tero Martikainen, MD, PhD, Study director, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721601
- Sponsor's protocol ID
- KUH507E015
- Status last verified
- Nov 2018
- First submitted
- 28 Feb 2018
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 LA, 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.
PubMed 28483832Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Alexandru Popescu B, Schotten U, Van Putte B, Vardas P. 2016 ESC Guidelines for the Management of Atrial Fibrillation Developed in Collaboration With EACTS. Rev Esp Cardiol (Engl Ed). 2017 Jan;70(1):50. doi: 10.1016/j.rec.2016.11.033. No abstract available. English, Spanish.
PubMed 28038729Nemati S, Ghassemi MM, Ambai V, Isakadze N, Levantsevych O, Shah A, Clifford GD. Monitoring and detecting atrial fibrillation using wearable technology. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:3394-3397. doi: 10.1109/EMBC.2016.7591456.
PubMed 28269032Thijs V. Atrial Fibrillation Detection: Fishing for An Irregular Heartbeat Before and After Stroke. Stroke. 2017 Oct;48(10):2671-2677. doi: 10.1161/STROKEAHA.117.017083. Epub 2017 Sep 15. No abstract available.
PubMed 28916671Mairesse GH, Moran P, Van Gelder IC, Elsner C, Rosenqvist M, Mant J, Banerjee A, Gorenek B, Brachmann J, Varma N, Glotz de Lima G, Kalman J, Claes N, Lobban T, Lane D, Lip GYH, Boriani G; ESC Scientific Document Group. Screening for atrial fibrillation: a European Heart Rhythm Association (EHRA) consensus document endorsed by the Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulacion Cardiaca y Electrofisiologia (SOLAECE). Europace. 2017 Oct 1;19(10):1589-1623. doi: 10.1093/europace/eux177. No abstract available.
PubMed 29048522Valiaho ES, Kuoppa P, Lipponen JA, Hartikainen JEK, Jantti H, Rissanen TT, Kolk I, Pohjantahti-Maaroos H, Castren M, Halonen J, Tarvainen MP, Santala OE, Martikainen TJ. Wrist Band Photoplethysmography Autocorrelation Analysis Enables Detection of Atrial Fibrillation Without Pulse Detection. Front Physiol. 2021 May 7;12:654555. doi: 10.3389/fphys.2021.654555. eCollection 2021.
PubMed 34025448
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Methods for Arrhythmia Detection: Chest Strap ECG and Wrist Band Photoplethysmography Compared to Holter-device for Atrial Fibrillation Detection
- ClinicalTrials.gov ID
- NCT03721601
- Acronym / sponsor ID
- KUH507E015
- Conditions
- Stroke, Atrial Fibrillation
- Keywords
- atrial fibrillation, stroke, atrial fibrillation screening, heart rate monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design was a prospective case-control multicenter study at three sites in Finland. Study material was collected in internal medicine emergency departments, cardiology wards and cardiology examination units of participating hospitals, Kuopio University Hospital, Helsinki University Central Hospital, Meilahti and North Karelia Central Hospital, Joensuu. The study design was approved by University of Eastern Finland ethics committee (237/2017).
Study participants received a written information sheet about the study and were provided with an opportunity to ask questions concerning the study. A written informed consent was signed by the participants, including a permission to use patient's medical records.
Screening of study participants was made in participating hospitals from admitted patients in May - September 2017. The inclusion criteria for study group patients was atrial fibrillation confirmed by a doctor-interpreted 12-lead ECG, taken for medical reasons. Exclusion criteria were: 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. Control group consisted of patients with normal sinus rhythm in 12-lead ECG.
Demographics of study patients, including age, gender, previous medical history (as reported by patient or from patient medical records), length, weight and BMI, was recorded.
First, a 12-lead ECG was taken over a period of 10 seconds for rhythm confirmation, after which the ECG electrodes were removed. In the next step, altogether 5 wet electrodes were attached to patient to record ECG with Faros 360 Holter device (Mega Elektroniikka, Kuopio, Finland; device 1) to be used as golden standard for rhythm monitoring. Simultaneously a heart rate monitoring chest strap (Suunto Movesense, Suunto, Vantaa, Finland; device 2) and wrist band photoplethysmography (PPG) (Empatica E4, Empatica inc., Cambridge, United States) was applied. A total of 5 min recording was made.
The data from heart rate chest strap was sent via Bluetooth connection to a mobile phone, from which it was transferred via a cable to study computer; the data from Faros Holter device was recorded to device´s internal memory card and transferred to analyzing software. PPG data were transferred to MATLAB® software version R2017b for pre-processing and analysis. The data collected was anonymized and ECG data from chest strap and Holter device was analyzed using MATLAB software.
The quality of the ECG-strip was defined as good (no or only minor artefacts), average (artefacts but QRS and/or P-wave identifiable) or poor (major artefacts, no identifiable QRS and/or P-wave) by the cardiologist. The rhythm from the ECG-strips was divided to three categories: sinus rhythm (SR), atrial fibrillation (AF) or other/inconclusive. The cardiologists also assessed the possibility to detect P-waves from the ECG-strips with sinus rhythm (yes/no).
The study population consisted of total 220 patients. According to the initial 12-lead ECG, total 110 patients with atrial fibrillation were collected, and control group consisted of 110 patients with normal sinus rhythm. The initial 12-lead ECG was only used to recruitment process of patients; later the division to sinus rhythm, atrial fibrillation or other rhythm used in the final analysis was made according to the cardiologist-interpreted Holter ECG.
Two commonly used AF detection algorithms were used in this work. Algorithms were used to demonstrate possibilities of automatic screening of AF using chest strap ECG devices with automated analysis.
Holter ECG serving as golden standard a total of 218 patients were included and 2 were excluded in the analysis. 2 of 220 3-lead Holter ECGs could be classified neither as sinus rhythm nor atrial fibrillation. One of them converted from atrial flutter to sinus rhythm during analysis and the quality of other ECG was insufficient for rhythm analysis. These two Holter ECGs and the corresponding chest strap ECGs were excluded from final analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation | – | Device: Heart rate monitor chest strap, Device: Wrist band photoplethysmographyPatients in atrial fibrillation as recorded by 3-lead Holter. |
| Sinus rhythm | – | Device: Heart rate monitor chest strap, Device: Wrist band photoplethysmographyPatients in sinus rhythm as recorded by 3-lead Holter. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in internal medicine emergency department, cardiology ward, cardiology examination unit
Key inclusion criteria (1 listed)
- Atrial fibrillation in 12-lead ECG
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate monitor chest strapSimultaneously with 5min Holter recording, 5min recording of chest strap ECG. | Device | Atrial fibrillation, Sinus rhythm |
| Wrist band photoplethysmographySimultaneously with 5min Holter recording, 5min recording wrist band photoplethysmography. | Device | Atrial fibrillation, Sinus rhythm |
Primary outcome
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
1 secondary outcome
Chest strap and PPG-device data quality to enable arrhythmia diagnosis
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Background: PubMed 28483832Freedman 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 LA, 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.
- Background: PubMed 28038729Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Alexandru Popescu B, Schotten U, Van Putte B, Vardas P. 2016 ESC Guidelines for the Management of Atrial Fibrillation Developed in Collaboration With EACTS. Rev Esp Cardiol (Engl Ed). 2017 Jan;70(1):50. doi: 10.1016/j.rec.2016.11.033. No abstract available. English, Spanish.
- Background: PubMed 28269032Nemati S, Ghassemi MM, Ambai V, Isakadze N, Levantsevych O, Shah A, Clifford GD. Monitoring and detecting atrial fibrillation using wearable technology. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:3394-3397. doi: 10.1109/EMBC.2016.7591456.
- Background: PubMed 28916671Thijs V. Atrial Fibrillation Detection: Fishing for An Irregular Heartbeat Before and After Stroke. Stroke. 2017 Oct;48(10):2671-2677. doi: 10.1161/STROKEAHA.117.017083. Epub 2017 Sep 15. No abstract available.
- Background: PubMed 29048522Mairesse GH, Moran P, Van Gelder IC, Elsner C, Rosenqvist M, Mant J, Banerjee A, Gorenek B, Brachmann J, Varma N, Glotz de Lima G, Kalman J, Claes N, Lobban T, Lane D, Lip GYH, Boriani G; ESC Scientific Document Group. Screening for atrial fibrillation: a European Heart Rhythm Association (EHRA) consensus document endorsed by the Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulacion Cardiaca y Electrofisiologia (SOLAECE). Europace. 2017 Oct 1;19(10):1589-1623. doi: 10.1093/europace/eux177. No abstract available.
- Derived from this study: PubMed 34025448Valiaho ES, Kuoppa P, Lipponen JA, Hartikainen JEK, Jantti H, Rissanen TT, Kolk I, Pohjantahti-Maaroos H, Castren M, Halonen J, Tarvainen MP, Santala OE, Martikainen TJ. Wrist Band Photoplethysmography Autocorrelation Analysis Enables Detection of Atrial Fibrillation Without Pulse Detection. Front Physiol. 2021 May 7;12:654555. doi: 10.3389/fphys.2021.654555. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tero Martikainen, MD, PhD study director
Kuopio University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Atrial Fibrillation, run by Kuopio University Hospital at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest strap and PPG-device data quality (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03721601, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.