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Trial registered on ANZCTR
Registration number
ACTRN12624001041549
Ethics application status
Approved
Date submitted
19/04/2024
Date registered
28/08/2024
Date last updated
28/08/2024
Date data sharing statement initially provided
28/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
CHIP-MI: Investigating the role of clonal haematopoiesis of indeterminate potential (CHIP) in the inflammatory system after myocardial infarction (MI).
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Scientific title
CHIP-MI: Investigating the role of clonal haematopoiesis of indeterminate potential (CHIP) in the inflammatory system after myocardial infarction (MI) in adults 65 years or older
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Secondary ID [1]
312003
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction
333612
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Condition category
Condition code
Cardiovascular
330300
330300
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0
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Coronary heart disease
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Consenting participants who have had a myocardial infarction will undergo the collection of clinical data sourced from the medical record, and blood samples will also be taken. The blood samples will be used for analysing lipids, inflammatory markers and other markers of vascular injury. The sample will also undergo genetic analysis for somatic gene mutations so that participants can be classified as having or not having clonal haematopoiesis of indeterminant potential. An additional blood sample will be stored for future biomedical research in participants who content to this. Participants may be followed for additional samples or medical records may be accessed within a 5 year period. Up to two additional blood samples may be taken at any time within a 2 year period, post-myocardial infarction.
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Intervention code [1]
328457
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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High sensitivity C-reactive protein levels in participants with or without clonal haematopoiesis of indeterminant potential, following myocardial infarction.
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Assessment method [1]
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Detection of high sensitivity C reactive protein will be undertaken by a pathology laboratory in plasma extracted from blood samples.
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Timepoint [1]
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The plasma levels will be detected once in participants within 3-12 months post-myocardial infarction.
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Primary outcome [2]
338679
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Interleukin 1 beta levels in participants with or without clonal haematopoiesis of indeterminant potential, following myocardial infarction.
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Assessment method [2]
338679
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Interleukin 1 beta levels will be measured in plasma extracted from blood samples by laboratory assay.
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Timepoint [2]
338679
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The plasma levels will be detected once in participants within 3-12 months post-myocardial infarction.
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Primary outcome [3]
338680
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Interleukin 6 levels in participants with or without clonal haematopoiesis of indeterminant potential, following myocardial infarction.
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Assessment method [3]
338680
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Interleukin 6 levels will be measured in plasma extracted from blood samples by laboratory assay.
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Timepoint [3]
338680
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The plasma levels will be detected once in participants within 3-12 months post-myocardial infarction.
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Secondary outcome [1]
434292
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Recovery from myocardial infarction
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Assessment method [1]
434292
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Rate of subsequent adverse events. Adverse events will be assessed as a composite secondary outcome. An example of an adverse event is subsequent myocardial infarction, chest pain or heart failure, which can be recorded from medical records; or worsened cardiac function which can be obtained from radiology reports in medical records. Where possible participants will be contacted for followup information at 5 years post-myocardial infarction.
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Timepoint [1]
434292
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Once, at 5 years post-myocardial infarction
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Secondary outcome [2]
437000
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Change in high sensitivity C-reactive protein levels in participants with or without clonal haematopoiesis of indeterminant potential up to 2 years after myocardial infarction.
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Assessment method [2]
437000
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Laboratory assays will be used to determine levels of high sensitivity C-reactive protein.
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Timepoint [2]
437000
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Plasma samples will be measured at baseline and one to two more times within 2 years of myocardial infarction.
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Secondary outcome [3]
437944
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Change in Interleukin 1 beta levels in participants with or without clonal haematopoiesis of indeterminant potential up to 2 years after myocardial infarction.
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Assessment method [3]
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Laboratory assays will be used to determine levels of interleukin 1b.
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Timepoint [3]
437944
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Plasma samples will be measured at baseline and one to two more times within 2 years of myocardial infarction.
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Secondary outcome [4]
437945
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Change in Interleukin 6 levels in participants with or without clonal haematopoiesis of indeterminant potential up to 2 years after myocardial infarction.
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Assessment method [4]
437945
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Laboratory assays will be used to determine levels of interleukin 6.
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Timepoint [4]
437945
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Plasma samples will be measured at baseline and one to two more times within 2 years of myocardial infarction.
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Secondary outcome [5]
439074
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CHIP allele frequency
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Assessment method [5]
439074
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Genetic analysis will be conducted to determine the frequency of variants in CHIP-related genes of DNA derived from the blood samples of participants.
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Timepoint [5]
439074
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Blood samples will be measured at baseline only.
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Secondary outcome [6]
439075
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Disease severity
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Assessment method [6]
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The disease severity will be captured from data obtained in medical records for example, degree of myocardial infarction, classification of myocardial infarction (i.e. non-ischaemic or ischaemic), cardiac function post-MI (i.e. ejection fraction if available), any pre-existing cardiovascular disease risk factors, cardiac imaging reports, circulating troponin levels and time spent in hospital.
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Timepoint [6]
439075
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At the time of hospitalisation for myocardial infarction (retrospective).
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Eligibility
Key inclusion criteria
1. Age 65 years or older
2. Able to provide written, voluntary and informed consent.
3. Willing to complete all study procedures during the visit.
4. Able to undergo collection of blood specimens.
5. Diagnosis of myocardial infarction 3-12 months prior to enrolment date.
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Unable to complete all study procedures during the visit.
2. Not appropriate to have blood collections for clinical reasons e.g. severe anemia, poor venous access, or other.
3. Presence of uncontrolled systemic inflammatory disease
4. Use of oral corticosteroids or use of disease modifying anti-rheumatic drugs
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
30/09/2024
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Actual
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Date of last participant enrolment
Anticipated
31/12/2025
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Actual
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Date of last data collection
Anticipated
31/12/2030
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
26452
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Victorian Heart Hospital - Clayton
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Recruitment postcode(s) [1]
42430
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3168 - Clayton
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Funding & Sponsors
Funding source category [1]
316347
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University
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Name [1]
316347
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In-kind support will be provided by Monash University in the form of staff time provided to conduct project.
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Address [1]
316347
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Country [1]
316347
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
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Country
Australia
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Secondary sponsor category [1]
318532
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None
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Name [1]
318532
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Address [1]
318532
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Country [1]
318532
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315158
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Monash Health Human Research Ethics Committee B
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Ethics committee address [1]
315158
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https://monashhealth.org/research/resources/resource-library/
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Ethics committee country [1]
315158
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Australia
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Date submitted for ethics approval [1]
315158
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20/09/2023
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Approval date [1]
315158
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29/02/2024
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Ethics approval number [1]
315158
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Summary
Brief summary
Clonal haematopoiesis of indeterminant potential (CHIP) is defined a genetic variation that leads to expansion of certain blood cells, particularly those with an immune function. CHIP is increasingly common beyond the age of 65 and associated with an increased risk of heart attack. The purpose of this study is to find out more about inflammatory processes after heart attack for CHIP positive patients compared to CHIP negative patients. We will screen for inflammatory markers and other molecular information in blood samples from people with and without CHIP who have had a recent heart attack.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Stephen Nicholls
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Address
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Victorian Heart Hospital, 631 Blackburn Rd, Clayton, Victoria, 3168
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Country
133858
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Australia
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Phone
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+61 3 7511 1682
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Fax
133858
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Email
133858
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[email protected]
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Contact person for public queries
Name
133859
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Dr Kristen Bubb
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Address
133859
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Victorian Heart Institute, Monash University, Level 2, 631 Blackburn Rd, Clayton, Victoria, 3168
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Country
133859
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Australia
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Phone
133859
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+61 3 75111857
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Fax
133859
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Email
133859
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[email protected]
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Contact person for scientific queries
Name
133860
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Dr Kristen Bubb
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Address
133860
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Victorian Heart Institute, Monash University, Level 2, 631 Blackburn Rd, Clayton, Victoria, 3168
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Country
133860
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Australia
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Phone
133860
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+61 3 75111857
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Fax
133860
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Email
133860
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
22245
Informed consent form
387700-(Uploaded-19-04-2024-16-33-26)-Study-related document.docx
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF