Sudden Cardiac ArrestNCT03715790
Improve SCA Bridge Study
An observational study of Sudden Cardiac Arrest and Acute Myocardial Infarction, run by Medtronic Cardiac Rhythm and Heart Failure at 52 sites in 16 countries.
Trial summary
The purpose of the Improve SCA Bridge study is to characterize the care pathway flow of post-acute myocardial infarction (MI) patients as a result of standard assessments of left ventricular ejection fraction (LVEF) in the acute phase (≤14 days post- acute MI) and chronic phase (≥40-90 days post-acute MI). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sudden Cardiac Arrest, Acute Myocardial Infarction
- What is being tested?
- EP referred group and Non-Referred group
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,491 participants
- Where
- 52 sitesin 16 countries
- Study dates
- 2 Nov 2018to 27 May 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have an acute Myocardial Infarction (MI) (STEMI or Non-STEMI).
Who may be able to join
- Age 18 and above (or meet age requirements per local law)
- Patients who have an acute Myocardial Infarction (MI) (STEMI or Non-STEMI) ≤ 30 days of study enrollment and have a LVEF <50% measurement ≤ 14 days post-acute MI
- Willing and able to give valid Informed Consent
Who cannot join
- Patient has previously received or currently implanted with an ICD or CRT-D
- Patient has any contraindication for ICD/CRT-D
- Patient has a life expectancy of less than 12 months
- Patient who has had an EP referral within the last 12 months
- Any exclusion criteria required by local law (e.g. pregnancy, breast feeding etc.)
- Patient is unable (e.g. mental disorder) or unwilling to be compliant with the responsibilities as specified in the informed consent form.
- Patient is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader
Trial locations and contacts
52 sites in 16 countries.
52 sites in 16 countries
China15 sites
Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
Peking University First Hospital
Beijing
The Second Xiangya Hospital of Central South University
Changsha
West China Hospital of Sichuan University
Chendu
Sun Yat-SEN Memorial hospital, Sun Yat-sen University
Guangzhou
Guizhou Provincial People's Hospital
Guizhou
Hangzhou First People Hospital
Hangzhou
Sir Run Run Shaw Hospital School of Medicine Zhejiang University
Hangzhou
The first Hospital of Lanzhou Hospital
Lanzhou
Nanjing First Hospital
Nanjing
Shanghai Chest Hospital
Shanghai
Sichuan Provincial People's Hospital
Sichuan
Wuhan Asia heart hospital
Wuhan
Xiamen Cardiovascular Hospital
Xiamen
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang
South Korea9 sites
Chonnam National University Hospital
Gwangju
Sejong General Hospital
Gyeonggi-do
Pusan National University Yangsan Hospital
Pusan
Asan Medical Center
Seoul
Keimyung University Dongsan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Bundang Hospital
Seoul
Seoul National University Hospital
Seoul
Taiwan6 sites
Kaohsiung Chang Gung Memorial Hospital of CGMF
Kaohsiung City
Far Eastern Memorial Hospital
New Taipei City
China Medical University Hospital
Taichung
Mackay Memorial Hospital
Taipei
National Taiwan University Hospital
Taipei
Linkou Chang Gung Memorial Hospital
Taoyuan
India5 sites
The Madras Medical Mission
Chennai
Eternal Hospital
Jaipur
Kasturba Medical College Hospital
Mangalore
Batra Hospital and Medical Research Centre (BHMRC)
New Delhi
Fortis Escorts Heart Institute
New Delhi
Malaysia3 sites
Hospital Serdang
Kajang
Queen Elizabeth II Hospital
Kota Kinabalu
Sarawak Heart Centre
Kota Samarahan
Indonesia2 sites
National Cardiovascular Center Harapan Kita
Jakarta
Rumah Sakit Cipto Mangunkusumo
Jakarta
Saudi Arabia2 sites
King Fahad Armed Forces Hospital
Jeddah
Prince Sultan Cardiac Center
Riyadh
South Africa2 sites
Mediclinic Panorama
Cape Town
Netcare Unitas Hospital
Pretoria
Bangladesh1 site
National Heart Foundation Hospital and Research Institute
Dhaka
Brunei1 site
Gleneagles Jerudong Park Medical Centre
Brunei
About this study
Official title: Improve Sudden Cardiac Arrest (SCA) Bridge Study
The purpose of the Improve SCA Bridge study is to characterize the care pathway flow of post-acute myocardial infarction (MI) patients as a result of standard assessments of left ventricular ejection fraction (LVEF) in the acute phase (≤14 days post- acute MI) and chronic phase (≥40-90 days post-acute MI).
Read the detailed description
To determine how many patients are referred for sudden cardiac death (SCD) risk stratification and management, indicated for implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy- defibrillator (CRT-D) implant, and how many receive such devices within 12 months of experiencing an MI.
- Conditions
- Sudden Cardiac Arrest, Acute Myocardial Infarction
- Being tested
- EP referred group, Non-Referred group
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP referred groupBehavioural
Referred for sudden cardiac death (SCD) risk stratification and management
Non-Referred groupBehavioural
Not referred for sudden cardiac death (SCD) risk stratification and management.
| Study group | Role | What they receive |
|---|---|---|
| EP Referred Group | Subjects with EF ≤ 40% or meeting one of the referral criteria Receives: Behavioral: EP referred group | |
| Non-Referred Group | Subjects with 40%< EF <50%. Receives: Behavioral: Non-Referred group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management
The numerator for this endpoint will be defined as the number of patients who met the clinician's determination to refer the subject for SCD risk stratification and management at any of the three follow-up visits. The denominator for this endpoint is the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this one arm.
No hypotheses were tested for this endpoint.
Measured: 3-months post-MI to 12-months post-MI
Secondary outcomes (5)
Percentage of Post-Acute MI Patients Who Are Known to be Indicated for an ICD/CRT-D Within 12 Months Post-MI
The numerator for this endpoint will be the number of subjects who were indicated for an ICD/CRT-D device during any of the three follow-up visits. The denominator will be the number of subjects who completed a 3-month follow-up visit.
While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this single arm. The analysis cannot be performed within the "referred" and "not referred" groups as patients not referred are not eligible for the secondary endpoints involving device indication or implant.
No hypotheses were tested for this endpoint.
Measured: 3-months post-MI to 12-months post-MI
Percentage of Post-Acute MI Patients Who Receive an ICD/CRT-D Within 12 Months Post-MI.
The numerator for this endpoint will be the number of subjects who received an ICD/CRT-D device during any of the three follow-up visits. The denominator for this endpoint will be the number of patients who completed a 3-month follow-up visit.
While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this single arm. The analysis cannot be performed within the "referred" and "not referred" groups as patients not referred are not eligible for the secondary endpoints involving device indication or implant.
No hypotheses were tested for this endpoint.
Measured: 3-months post-MI to 12-months post-MI
Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD
The outcome measure will be the percentage of patients with ICD indication, who were not referred, refused referral or refused implant. The denominator will count all patients with at least one of the below:
- a reduced ejection fraction, as measured by the Left Ventricular Ejection Fraction (LVEF) being lower or equal than 40%. >
- ventricular arrhythmia, AV block, new onset bundle branch block, or conduction abnormalities as measured by ECGs. >
- unexplained syncope, clinically significant palpitations or symptomatic bradycardia as assessed by the physician. > The numerator will count the patients included in the denominator who were not referred, refused referral or refused implant of an ICD/CRT-D. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the referral process results in the single arm of enrolled patients, with analysis performed within this arm. No hypotheses were tested for this endpoint.
Measured: 3-months post-MI to 12-months post-MI
Percentage of Post-Acute MI Patients Who Experience Cardiovascular Mortality
The numerator for this endpoint will be the number of patients who experience cardiovascular mortality. The denominator will be the number of patients enrolled in the study.
No hypotheses were tested for this endpoint.
Measured: Enrollment to 12-months post-MI
Evolution of the Ejection Fraction Over the Immediate Period of Post MI
The Left Ventricular Ejection Fraction (LVEF) will be measured acutely post MI (≤14 days after MI onset) and chronically (40-90 days). The acute measurement will occur over all 1491 subjects assessed at baseline, while the chronic assessment will be measured over the 1046 subjects with a 3-month LVEF assessment. This outcome will compare the average LVEF, by percent, between these two phases.
No hypotheses were tested for this endpoint.
Measured: Enrollment to 3-months post-MI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start2 Nov 2018
- Primary completion16 Apr 2021
- Study completion27 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sudden Cardiac ArrestStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,491 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shu Zhang, Principal investigator, Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715790
- Sponsor's protocol ID
- MDT18019
- Status last verified
- Apr 2023
- First submitted
- 3 Oct 2018
- Last updated
- 16 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chew DS, Wilton SB, Kavanagh K, Southern DA, Tan-Mesiatowsky LE, Exner DV; APPROACH Investigators. Left ventricular ejection fraction reassessment post-myocardial infarction: Current clinical practice and determinants of adverse remodeling. Am Heart J. 2018 Apr;198:91-96. doi: 10.1016/j.ahj.2017.11.014. Epub 2017 Dec 5.
PubMed 29653653Adabag AS, Therneau TM, Gersh BJ, Weston SA, Roger VL. Sudden death after myocardial infarction. JAMA. 2008 Nov 5;300(17):2022-9. doi: 10.1001/jama.2008.553.
PubMed 18984889Chia YMF, Teng TK, Tan ESJ, Tay WT, Richards AM, Chin CWL, Shimizu W, Park SW, Hung CL, Ling LH, Ngarmukos T, Omar R, Siswanto BB, Narasimhan C, Reyes EB, Yu CM, Anand I, MacDonald MR, Yap J, Zhang S, Finkelstein EA, Lam CSP. Disparity Between Indications for and Utilization of Implantable Cardioverter Defibrillators in Asian Patients With Heart Failure. Circ Cardiovasc Qual Outcomes. 2017 Nov;10(11):e003651. doi: 10.1161/CIRCOUTCOMES.116.003651.
PubMed 29150533O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the American College of Emergency Physicians and Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2013 Jul 1;82(1):E1-27. doi: 10.1002/ccd.24776. Epub 2013 Jan 8. No abstract available.
PubMed 23299937Zhang S, Chen WJ, Sankardas MA, Ahmed WH, Liew HB, Gwon HC, Nesa Malik FT, Tang B, Haggui A, Oh IY, Ong TK, Cheng CI, Liu X, Seth A, Choi YJ, Qamar N, Rungpradubvong V, Wang CC, Jeon J, Wong G, Lemme F, Van Dorn B, Lexcen D, Huang D; Improve Sudden Cardiac Arrest Bridge Investigators. Improve the Prevention of Sudden Cardiac Arrest in Patients With Post-Acute Myocardial Infarction. JACC Asia. 2022 Sep 20;2(5):559-571. doi: 10.1016/j.jacasi.2022.06.006. eCollection 2022 Oct.
PubMed 36518723
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improve Sudden Cardiac Arrest (SCA) Bridge Study
- ClinicalTrials.gov ID
- NCT03715790
- Acronym / sponsor ID
- MDT18019
- Conditions
- Sudden Cardiac Arrest, Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,491 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Posted 16 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the Improve SCA Bridge study is to characterize the care pathway flow of post-acute myocardial infarction (MI) patients as a result of standard assessments of left ventricular ejection fraction (LVEF) in the acute phase (≤14 days post- acute MI) and chronic phase (≥40-90 days post-acute MI).
Detailed description
To determine how many patients are referred for sudden cardiac death (SCD) risk stratification and management, indicated for implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy- defibrillator (CRT-D) implant, and how many receive such devices within 12 months of experiencing an MI.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EP Referred Group | – | Behavioral: EP referred groupSubjects with EF ≤ 40% or meeting one of the referral criteria |
| Non-Referred Group | – | Behavioral: Non-Referred groupSubjects with 40%< EF <50%. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have an acute Myocardial Infarction (MI) (STEMI or Non-STEMI).
Key inclusion criteria (3 listed)
- Age 18 and above (or meet age requirements per local law)
- Patients who have an acute Myocardial Infarction (MI) (STEMI or Non-STEMI) ≤ 30 days of study enrollment and have a LVEF <50% measurement ≤ 14 days post-acute MI
- Willing and able to give valid Informed Consent
Key exclusion criteria (7 listed)
- Patient has previously received or currently implanted with an ICD or CRT-D
- Patient has any contraindication for ICD/CRT-D
- Patient has a life expectancy of less than 12 months
- Patient who has had an EP referral within the last 12 months
- Any exclusion criteria required by local law (e.g. pregnancy, breast feeding etc.)
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 |
|---|---|---|
| EP referred groupReferred for sudden cardiac death (SCD) risk stratification and management | Behavioural | EP Referred Group |
| Non-Referred groupNot referred for sudden cardiac death (SCD) risk stratification and management. | Behavioural | Non-Referred Group |
Primary outcome
Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management
Time frame: 3-months post-MI to 12-months post-MI
The numerator for this endpoint will be defined as the number of patients who met the clinician's determination to refer the subject for SCD risk stratification and management at any of the three follow-up visits. The denominator for this endpoint is the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this one arm. No hypotheses were tested for this endpoint.
5 secondary outcomes
Percentage of Post-Acute MI Patients Who Are Known to be Indicated for an ICD/CRT-D Within 12 Months Post-MI
Time frame: 3-months post-MI to 12-months post-MI
Percentage of Post-Acute MI Patients Who Receive an ICD/CRT-D Within 12 Months Post-MI.
Time frame: 3-months post-MI to 12-months post-MI
Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD
Time frame: 3-months post-MI to 12-months post-MI
Percentage of Post-Acute MI Patients Who Experience Cardiovascular Mortality
Time frame: Enrollment to 12-months post-MI
Evolution of the Ejection Fraction Over the Immediate Period of Post MI
Time frame: Enrollment to 3-months post-MI
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29653653Chew DS, Wilton SB, Kavanagh K, Southern DA, Tan-Mesiatowsky LE, Exner DV; APPROACH Investigators. Left ventricular ejection fraction reassessment post-myocardial infarction: Current clinical practice and determinants of adverse remodeling. Am Heart J. 2018 Apr;198:91-96. doi: 10.1016/j.ahj.2017.11.014. Epub 2017 Dec 5.
- Results publication: PubMed 18984889Adabag AS, Therneau TM, Gersh BJ, Weston SA, Roger VL. Sudden death after myocardial infarction. JAMA. 2008 Nov 5;300(17):2022-9. doi: 10.1001/jama.2008.553.
- Results publication: PubMed 29150533Chia YMF, Teng TK, Tan ESJ, Tay WT, Richards AM, Chin CWL, Shimizu W, Park SW, Hung CL, Ling LH, Ngarmukos T, Omar R, Siswanto BB, Narasimhan C, Reyes EB, Yu CM, Anand I, MacDonald MR, Yap J, Zhang S, Finkelstein EA, Lam CSP. Disparity Between Indications for and Utilization of Implantable Cardioverter Defibrillators in Asian Patients With Heart Failure. Circ Cardiovasc Qual Outcomes. 2017 Nov;10(11):e003651. doi: 10.1161/CIRCOUTCOMES.116.003651.
- Results publication: PubMed 23299937O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the American College of Emergency Physicians and Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2013 Jul 1;82(1):E1-27. doi: 10.1002/ccd.24776. Epub 2013 Jan 8. No abstract available.
- Derived from this study: PubMed 36518723Zhang S, Chen WJ, Sankardas MA, Ahmed WH, Liew HB, Gwon HC, Nesa Malik FT, Tang B, Haggui A, Oh IY, Ong TK, Cheng CI, Liu X, Seth A, Choi YJ, Qamar N, Rungpradubvong V, Wang CC, Jeon J, Wong G, Lemme F, Van Dorn B, Lexcen D, Huang D; Improve Sudden Cardiac Arrest Bridge Investigators. Improve the Prevention of Sudden Cardiac Arrest in Patients With Post-Acute Myocardial Infarction. JACC Asia. 2022 Sep 20;2(5):559-571. doi: 10.1016/j.jacasi.2022.06.006. eCollection 2022 Oct.
- 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.
Shu Zhang principal investigator
Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
52 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Arrest and Acute Myocardial Infarction, run by Medtronic Cardiac Rhythm and Heart Failure at 52 sites in 16 countries.
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 3 inclusion and 7 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 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in China, South Korea, Taiwan, India, Malaysia and 11 more countries. 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?
Yes. Results are posted in the registry (first posted 16 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management (time frame: 3-months post-MI to 12-months post-MI). 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 NCT03715790, which also lists 5 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 16 Jan 2024.