Acute Coronary SyndromeICRRNCT04676100
International CR Registry
An observational study of Acute Coronary Syndrome and Heart Failure, run by University Health Network, Toronto at 1 site in Qatar.
Trial summary
The ICRR is a health services registry to establish the quality of CR delivery, and the effectiveness in terms of patient outcomes, in low-resource settings. The purposes of the registry are care optimization, evidentiary support for CR advocacy / policy, and research. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Heart Failure, Coronary Artery Disease
- What is being tested?
- Cardiac rehabilitation
- How many people
- 7,000 participants
- Where
- 1 siteQatar
- Study dates
- 27 Sep 2021to 30 Jun 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Coronary heart disease patients who are indicated for CR are eligible for registry inclusion (e.g., acute coronary syndrome +/- revascularization, heart failure, stable coronary artery disease +/- valve or rhythm conditions); there are some exclusions to CR eligibility such as inability to ambulate.
Who may be able to join
- SITES:
- CR program (defined in intervention section)
- in low-resource setting (i.e., low or middle-income country according to World Bank, or in region within a higher-income country where there is under-development of CR related to financial resources, lack of healthcare system resources, lack of patient and provider awareness, and/or patient disadvantage [e.g., limited social resources, geographic barriers])
Who cannot join
- SITES:
- -program cannot enter data in English
- PATIENTS:
- not capable to understand the registry information letter for cognitive or mental reasons (although they would also likely be excluded from CR).
- not proficient in the language of the local ethics-approved registry information letter /consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: International Cardiac Rehabilitation Registry (ICRR) Protocol
The ICRR is a health services registry to establish the quality of CR delivery, and the effectiveness in terms of patient outcomes, in low-resource settings. The purposes of the registry are care optimization, evidentiary support for CR advocacy / policy, and research.
All programs in low-resource settings will be welcome to participate at no cost. Programs will follow procedures approved by their local ethics board for collection of program and patient-reported variables. Assessments occur pre-cardiac rehabilitation (CR), post-CR and annually thereafter.
Read the detailed description
The user sub-committee has a formal site on-boarding process. Participating sites will be encouraged to enter data on all patients meeting inclusion / exclusion criteria to reduce bias. Prospective / concurrent data collection will be encouraged, to support quality improvement activities.
The company Dendrite will host the registry and ensure data security. Privacy protections will be in place, and no identifying information such as names will be entered into the registry. Data entered from sites into the registry is secured through encryption added to secure HTTP, done using Transport Layer Security. Stored data is also encrypted using InterSystems Cache database software.
There is an ICRR program survey assessing structural CR indicators. The registry variable list for patient-level data was developed based on recommendations of the Core Outcome Set-STAndards for Development (COS-STAD), through a delphi process. The final variable list and data dictionary can be found here: https://globalcardiacrehab.com/ICRR-Governance.
There are 10 program-reported variables and 16 patient-reported variables (some variables are assessed at multiple time points), assessed pre-program, post-program (dependent upon duration of each program) and each year from initial assessment (until patients expire or are unable to complete the assessments, which is ascertained by the program, or patient opt-out/withdrawal). Sites can arrange electronic data capture for the program-reported variables to contribute data to the registry, rather than manual electronic entry.
Descriptive statistics (i.e. means and standard deviations for continuous variables and frequencies with percentages for categorical variables) will be used to describe the quality of care (outcomes below). For testing change in patient outcomes pre to post-program, paired t-tests will also be used for continuous variables and chi-square test for categorical variables.
Univariate and multivariate approaches will be used to identify factors associated with outcomes, including the use of guideline-indicated therapies. Associations between patient characteristics and outcomes tested via logistic regression will be reported with odds ratios and 95% confidence intervals. Associations will be considered statistically significant when 2-sided α is <0.05. Appropriate statistical corrections for repeated measures will be performed. To limit the influence of confounding, multivariate adjustment will be used, including propensity weighting, or other techniques. Risk adjustment (e.g., socioeconomic status, indication, comorbidities, age) will be undertaken.
The registry has a data quality dashboard which displays by site completeness of data entry at each assessment point, to help reduce bias. The registry has in-built minimum and maximum values for continuous variables to reduce data entry errors. The data dictionary clearly defines each variable, and new sites are trained prior to start. The registry is being usability tested prior to launch, and piloted in Qatar. The research sub-committee will oversee a data quality process; Data audits may be supported by a registry database analyst / professional statistician.
Patient perspectives were considered in the development of the variable list and outcomes. A registry page for patients is in development (https://globalcardiacrehab.com/ICRR-for-Patients). Patients have a voice on ICRR's user sub-committee. Patients providing data pre and post-program may receive a lay summary of their progress. Lay summaries of annual registry reports may be shared with interested patients.
- Being tested
- Cardiac rehabilitation
- Keywords
- registry, cardiac rehabilitation, mortality, equity, quality of care, patient engagement, audit and feedback, health behavior, patient-reported outcomes, depression
- Medical subject headings
- Acute Coronary Syndrome, Heart Failure, Coronary Artery Disease, Patient Participation, Health Behavior, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitationOther
Also called quality improvement initiatives, feedback
A CR program is defined as one that offers initial assessment, structured exercise (can be supervised or unsupervised) and at least one other strategy to control risk factors. The registry pertains to phase II CR.
Quality of care and patient outcomes are benchmarked with other countries anonymously, through 2 registry dashboards (real-time). The dashboards will also show change over time in 6-month increments; Sites will be encouraged to continue to provide data on new patients until all indicators show quality as possible.
Sites will be supported in quality improvement by the ICRR user sub-committee. High-performing programs will be recognized on ICRR's website and ICCPR's social media accounts. This mechanism may be used in future to support program accreditation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
all-cause mortality, assessed via phone call
Measured: assessed annually from initial assessment date until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Morbidity
CV event or procedure, emergency department visit for cardiac cause, or any cause hospitalization, and/or other new health condition assessed via self-report
Measured: assessed annually from initial assessment date until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Secondary outcomes (9)
Cardiac Symptoms
frequency of shortness of breath, dizziness, or chest pain in past month, assessed via self-report item (investigator-generated item based on https://www.ichom.org/portfolio/coronary-artery-disease/)
Measured: assessed annually from initial assessment date until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Functional capacity
peak METs, which could be calculated based on exercise test (treadmill or bike), Duke Activity Status Index, or 6-minute walk test
Measured: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)
Low-density lipoprotein
in mmol/L or mg/dL from lab report
Measured: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)
Body mass index
weight and height will be combined to report BMI in kg/m^2
Measured: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)
Blood pressure
systolic and diastolic (mmHg), assessed manually or with a validated automated device
Measured: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)
Work status
return-to-work, if applicable, assessed via self-report of work status
Measured: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annually until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 yea
Psychosocial well-being
quality of life (Cantril's ladder) \& depressive symptoms (PHQ-2)
Measured: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Quality of life
Cantril's ladder of life (10 rungs)
Measured: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Depressive symptoms
PHQ-2
Measured: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start27 Sep 2021
- Primary completion30 Jun 2036 (estimated)
- Study completion30 Jun 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- International Council of Cardiovascular Prevention and Rehabilitation (ICCPR, York University, Qatar University
- Responsible party
- Principal investigator, Sherry Grace, York University
- Investigators
- Sherry L Grace, Principal investigator, York University & University Health NetworkKaram Turk-Adawi, PhD, Principal investigator, Qatar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676100
- Sponsor's protocol ID
- York U ethics e2020-359
- Other IDs
- 215
- Acronym
- ICRR
- Status last verified
- Nov 2023
- First submitted
- 9 Dec 2020
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The ICCR will explore potential public posting of anonymous registry data in a repository in future, to augment utility of the data through availability to the scientific community. Specific sites may also apply for ethics approval for administrative data linkage (e.g., clinical databases, imaging or lab data, government databases or surveys), which could enable cost-effectiveness analysis for example. Contributing sites may also apply for ethics approval to survey patients over and above registry assessments. Any secondary use of the data for research purposes will go through separate ethical review. Requests will be vetted by the ICRR research sub-committee. No data will be released that could identify patients. This may include sharing of aggregate data on common variables with other CR registries. This research may be published in peer-reviewed journals and presented at scholarly conferences.
Publications
Poffley A, Thomas E, Grace SL, Neubeck L, Gallagher R, Niebauer J, O'Neil A. A systematic review of cardiac rehabilitation registries. Eur J Prev Cardiol. 2017 Oct;24(15):1596-1609. doi: 10.1177/2047487317724576. Epub 2017 Aug 1.
PubMed 28762761Gliklich RE, Dreyer NA, Leavy MB, editors. Registries for Evaluating Patient Outcomes: A User's Guide [Internet]. 3rd edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Apr. Report No.: 13(14)-EHC111. Available from http://www.ncbi.nlm.nih.gov/books/NBK208616/
PubMed 24945055Chowdhury MI, Turk-Adawi K, Babu AS, de Melo Ghisi GL, Seron P, Yeo TJ, Uddin J, Heine M, Saldivia MG, Kouidi E, Sadeghi M, Aljehani R, Grace SL. Development of the International Cardiac Rehabilitation Registry Including Variable Selection and Definition Process. Glob Heart. 2022 Jan 11;17(1):1. doi: 10.5334/gh.1091. eCollection 2022.
PubMed 35174042Abukhadijah HJ, Turk-Adawi KI, Dewart N, Grace SL. Qualitative study measuring the usability of the International Cardiac Rehabilitation Registry. BMJ Open. 2022 Aug 29;12(8):e064255. doi: 10.1136/bmjopen-2022-064255.
PubMed 36038174
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Cardiac Rehabilitation Registry (ICRR) Protocol
- ClinicalTrials.gov ID
- NCT04676100
- Acronym / sponsor ID
- ICRR / York U ethics e2020-359
- Keywords
- registry, cardiac rehabilitation, mortality, equity, quality of care, patient engagement, audit and feedback, health behavior
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- International Council of Cardiovascular Prevention and Rehabilitation (ICCPR, York University, Qatar University
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 30 Jun 2036 (estimated)
- Study completion
- 30 Jun 2041 (estimated)
- First posted
- 19 Dec 2020 (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.
The ICRR is a health services registry to establish the quality of CR delivery, and the effectiveness in terms of patient outcomes, in low-resource settings. The purposes of the registry are care optimization, evidentiary support for CR advocacy / policy, and research.
All programs in low-resource settings will be welcome to participate at no cost. Programs will follow procedures approved by their local ethics board for collection of program and patient-reported variables. Assessments occur pre-cardiac rehabilitation (CR), post-CR and annually thereafter.
Detailed description
The user sub-committee has a formal site on-boarding process. Participating sites will be encouraged to enter data on all patients meeting inclusion / exclusion criteria to reduce bias. Prospective / concurrent data collection will be encouraged, to support quality improvement activities.
The company Dendrite will host the registry and ensure data security. Privacy protections will be in place, and no identifying information such as names will be entered into the registry. Data entered from sites into the registry is secured through encryption added to secure HTTP, done using Transport Layer Security. Stored data is also encrypted using InterSystems Cache database software.
There is an ICRR program survey assessing structural CR indicators. The registry variable list for patient-level data was developed based on recommendations of the Core Outcome Set-STAndards for Development (COS-STAD), through a delphi process. The final variable list and data dictionary can be found here: https://globalcardiacrehab.com/ICRR-Governance.
There are 10 program-reported variables and 16 patient-reported variables (some variables are assessed at multiple time points), assessed pre-program, post-program (dependent upon duration of each program) and each year from initial assessment (until patients expire or are unable to complete the assessments, which is ascertained by the program, or patient opt-out/withdrawal). Sites can arrange electronic data capture for the program-reported variables to contribute data to the registry, rather than manual electronic entry.
Descriptive statistics (i.e. means and standard deviations for continuous variables and frequencies with percentages for categorical variables) will be used to describe the quality of care (outcomes below). For testing change in patient outcomes pre to post-program, paired t-tests will also be used for continuous variables and chi-square test for categorical variables.
Univariate and multivariate approaches will be used to identify factors associated with outcomes, including the use of guideline-indicated therapies. Associations between patient characteristics and outcomes tested via logistic regression will be reported with odds ratios and 95% confidence intervals. Associations will be considered statistically significant when 2-sided α is <0.05. Appropriate statistical corrections for repeated measures will be performed. To limit the influence of confounding, multivariate adjustment will be used, including propensity weighting, or other techniques. Risk adjustment (e.g., socioeconomic status, indication, comorbidities, age) will be undertaken.
The registry has a data quality dashboard which displays by site completeness of data entry at each assessment point, to help reduce bias. The registry has in-built minimum and maximum values for continuous variables to reduce data entry errors. The data dictionary clearly defines each variable, and new sites are trained prior to start. The registry is being usability tested prior to launch, and piloted in Qatar. The research sub-committee will oversee a data quality process; Data audits may be supported by a registry database analyst / professional statistician.
Patient perspectives were considered in the development of the variable list and outcomes. A registry page for patients is in development (https://globalcardiacrehab.com/ICRR-for-Patients). Patients have a voice on ICRR's user sub-committee. Patients providing data pre and post-program may receive a lay summary of their progress. Lay summaries of annual registry reports may be shared with interested patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Coronary heart disease patients who are indicated for CR are eligible for registry inclusion (e.g., acute coronary syndrome +/- revascularization, heart failure, stable coronary artery disease +/- valve or rhythm conditions); there are some exclusions to CR eligibility such as inability to ambulate.
Key inclusion criteria (3 listed)
- CR program (defined in intervention section)
- in low-resource setting (i.e., low or middle-income country according to World Bank, or in region within a higher-income country where there is under-development of CR related to financial resources, lack of healthcare system resources, lack of patient and provider awareness, and/or patient disadvantage [e.g., limited social resources, geographic barriers])
Key exclusion criteria (5 listed)
- -program cannot enter data in English
- not capable to understand the registry information letter for cognitive or mental reasons (although they would also likely be excluded from CR).
- not proficient in the language of the local ethics-approved registry information letter /consent form.
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 |
|---|---|---|
| Cardiac rehabilitationAlso: quality improvement initiatives, feedbackA CR program is defined as one that offers initial assessment, structured exercise (can be supervised or unsupervised) and at least one other strategy to control risk factors. The registry pertains to phase II CR. Quality of care and patient outcomes are benchmarked with other countries anonymously, through 2 registry dashboards (real-time). The dashboards will also show change over time in 6-month increments; Sites will be encouraged to continue to provide data on new patients until all indicators show quality as possible. Sites will be supported in quality improvement by the ICRR user sub-committee. High-performing programs will be recognized on ICRR's website and ICCPR's social media accounts. This mechanism may be used in future to support program accreditation. | Other | – |
Primary outcome
Mortality
Time frame: assessed annually from initial assessment date until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
all-cause mortality, assessed via phone call
Morbidity
Time frame: assessed annually from initial assessment date until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
CV event or procedure, emergency department visit for cardiac cause, or any cause hospitalization, and/or other new health condition assessed via self-report
9 secondary outcomes
Cardiac Symptoms
Time frame: assessed annually from initial assessment date until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Functional capacity
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)
Low-density lipoprotein
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)
Body mass index
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)
Blood pressure
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)
Work status
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annually until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 yea
Psychosocial well-being
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Quality of life
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Depressive symptoms
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Background: PubMed 28762761Poffley A, Thomas E, Grace SL, Neubeck L, Gallagher R, Niebauer J, O'Neil A. A systematic review of cardiac rehabilitation registries. Eur J Prev Cardiol. 2017 Oct;24(15):1596-1609. doi: 10.1177/2047487317724576. Epub 2017 Aug 1.
- Background: PubMed 24945055Gliklich RE, Dreyer NA, Leavy MB, editors. Registries for Evaluating Patient Outcomes: A User's Guide [Internet]. 3rd edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Apr. Report No.: 13(14)-EHC111. Available from http://www.ncbi.nlm.nih.gov/books/NBK208616/
- Background: PubMed 35174042Chowdhury MI, Turk-Adawi K, Babu AS, de Melo Ghisi GL, Seron P, Yeo TJ, Uddin J, Heine M, Saldivia MG, Kouidi E, Sadeghi M, Aljehani R, Grace SL. Development of the International Cardiac Rehabilitation Registry Including Variable Selection and Definition Process. Glob Heart. 2022 Jan 11;17(1):1. doi: 10.5334/gh.1091. eCollection 2022.
- Background: PubMed 36038174Abukhadijah HJ, Turk-Adawi KI, Dewart N, Grace SL. Qualitative study measuring the usability of the International Cardiac Rehabilitation Registry. BMJ Open. 2022 Aug 29;12(8):e064255. doi: 10.1136/bmjopen-2022-064255.
- Registry page for interested programs and the CR community. Patient website to be developedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The ICCR will explore potential public posting of anonymous registry data in a repository in future, to augment utility of the data through availability to the scientific community. Specific sites may also apply for ethics approval for administrative data linkage (e.g., clinical databases, imaging or lab data, government databases or surveys), which could enable cost-effectiveness analysis for example. Contributing sites may also apply for ethics approval to survey patients over and above registry assessments. Any secondary use of the data for research purposes will go through separate ethical review. Requests will be vetted by the ICRR research sub-committee. No data will be released that could identify patients. This may include sharing of aggregate data on common variables with other CR registries. This research may be published in peer-reviewed journals and presented at scholarly conferences.
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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.
Sherry L Grace principal investigator
York University & University Health Network
Karam Turk-Adawi, PhD principal investigator
Qatar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Heart Failure, run by University Health Network, Toronto at 1 site in Qatar.
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 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: enrolling by invitation, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. 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?
This study is still under way. Results are not available in the source record yet.
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?
Mortality (time frame: assessed annually from initial assessment date until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years). The study lists 2 primary outcomes in all. 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 NCT04676100, which also lists 4 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 4 Dec 2023.