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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).
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
Secondary ID [1] 312003 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 333612 0
Condition category
Condition code
Cardiovascular 330300 330300 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 328457 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338042 0
High sensitivity C-reactive protein levels in participants with or without clonal haematopoiesis of indeterminant potential, following myocardial infarction.
Timepoint [1] 338042 0
The plasma levels will be detected once in participants within 3-12 months post-myocardial infarction.
Primary outcome [2] 338679 0
Interleukin 1 beta levels in participants with or without clonal haematopoiesis of indeterminant potential, following myocardial infarction.
Timepoint [2] 338679 0
The plasma levels will be detected once in participants within 3-12 months post-myocardial infarction.
Primary outcome [3] 338680 0
Interleukin 6 levels in participants with or without clonal haematopoiesis of indeterminant potential, following myocardial infarction.
Timepoint [3] 338680 0
The plasma levels will be detected once in participants within 3-12 months post-myocardial infarction.
Secondary outcome [1] 434292 0
Recovery from myocardial infarction
Timepoint [1] 434292 0
Once, at 5 years post-myocardial infarction
Secondary outcome [2] 437000 0
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.
Timepoint [2] 437000 0
Plasma samples will be measured at baseline and one to two more times within 2 years of myocardial infarction.
Secondary outcome [3] 437944 0
Change in Interleukin 1 beta levels in participants with or without clonal haematopoiesis of indeterminant potential up to 2 years after myocardial infarction.
Timepoint [3] 437944 0
Plasma samples will be measured at baseline and one to two more times within 2 years of myocardial infarction.
Secondary outcome [4] 437945 0
Change in Interleukin 6 levels in participants with or without clonal haematopoiesis of indeterminant potential up to 2 years after myocardial infarction.
Timepoint [4] 437945 0
Plasma samples will be measured at baseline and one to two more times within 2 years of myocardial infarction.
Secondary outcome [5] 439074 0
CHIP allele frequency
Timepoint [5] 439074 0
Blood samples will be measured at baseline only.
Secondary outcome [6] 439075 0
Disease severity
Timepoint [6] 439075 0
At the time of hospitalisation for myocardial infarction (retrospective).

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.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26452 0
Victorian Heart Hospital - Clayton
Recruitment postcode(s) [1] 42430 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 316347 0
University
Name [1] 316347 0
In-kind support will be provided by Monash University in the form of staff time provided to conduct project.
Country [1] 316347 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318532 0
None
Name [1] 318532 0
Address [1] 318532 0
Country [1] 318532 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315158 0
Monash Health Human Research Ethics Committee B
Ethics committee address [1] 315158 0
Ethics committee country [1] 315158 0
Australia
Date submitted for ethics approval [1] 315158 0
20/09/2023
Approval date [1] 315158 0
29/02/2024
Ethics approval number [1] 315158 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133858 0
Prof Stephen Nicholls
Address 133858 0
Victorian Heart Hospital, 631 Blackburn Rd, Clayton, Victoria, 3168
Country 133858 0
Australia
Phone 133858 0
+61 3 7511 1682
Fax 133858 0
Email 133858 0
stephen.nicholls@monash.edu
Contact person for public queries
Name 133859 0
Dr Kristen Bubb
Address 133859 0
Victorian Heart Institute, Monash University, Level 2, 631 Blackburn Rd, Clayton, Victoria, 3168
Country 133859 0
Australia
Phone 133859 0
+61 3 75111857
Fax 133859 0
Email 133859 0
kristen.bubb@monash.edu
Contact person for scientific queries
Name 133860 0
Dr Kristen Bubb
Address 133860 0
Victorian Heart Institute, Monash University, Level 2, 631 Blackburn Rd, Clayton, Victoria, 3168
Country 133860 0
Australia
Phone 133860 0
+61 3 75111857
Fax 133860 0
Email 133860 0
kristen.bubb@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22245Informed 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.