Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001274662
Ethics application status
Approved
Date submitted
14/07/2023
Date registered
7/12/2023
Date last updated
7/12/2023
Date data sharing statement initially provided
7/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Myocardial Infarction in the Young: A Prospective Clinical Registry Study
Scientific title
Myocardial Infarction in the Young: A Prospective Clinical Registry Study
Secondary ID [1] 310135 0
Nil
Universal Trial Number (UTN)
Trial acronym
Young MI Registry (Prospective)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction
 330695 0
Condition category
Condition code
Cardiovascular 327524 327524 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
4
Target follow-up type
Years
Description of intervention(s) / exposure
This is an investigator-initiated, observational, single-centre clinical registry study of young patients with Myocardial Infarction (MI). Patients will be recruited at Westmead hospital post MI, after they are considered to be in stable condition or pre-discharge.
Eligible patients at Westmead Hospital will be identified and recruited into the study prospectively by the research team.
Prospective patients will be recruited upon admission with a diagnosis of myocardial infarction. Follow up will be performed at 30 days, 1 year and yearly thereafter for up to 4 years. Questionnaires will be sent directly to participants and will take ~5-7min to complete each questionnaire. The questionnaire are to collect their pre- and post-myocardial infarction family and medical history, exercise, stress, quality of life and medication use data. As this is an observational study, all data will be collected either from participants medical records or questionnaires. No additional tests and cardiac scans for this study purpose will be required.

Participants will sign their informed consent for their medical records to be accessed/collected, as well as centralised data collection, and for ongoing yearly follow up for 4 years, with the ability to opt-out at any stage. They will also be asked regarding their willingness to be contacted about future clinical trials. This study will be completely observational in nature, and no intervention will be performed.
If patients only consent for the observational study but not the blood collection, consenting may be performed via a telephone consultation if required by a research nurse or study coordinator. Participants will be mailed or emailed the participant information and consent form for reading. After a few days they will be re-contacted to obtain/record their consent.
Face-to-face consenting will be used for all patients who wish to consent for blood collection. If participant provides additional consent to collect blood for additional genomics and proteomics analysis, a one-off 40mL blood sample ( at baseline) will be taken via an intravenous cannula, or by venepuncture if a cannula is not available. The blood will be collected in EDTA, serum and citrate tubes. The samples will be stored at -80oC in locked and alarmed freezers at the Westmead Institute of Medical Research (WIMR). Blood samples will be tested for cell adhesion and inflammation markers such as VCAM-1, ICAM-1 and IL-6. NETs markers in samples will be analysed using immunochemistry staining and ELISA. Flow cytometry will also be performed.

Patients will be recruited with their baseline clinical data entered locally by a study coordinator, into an online centralised database. Baseline data includes background medical history, cardiovascular risk factors (traditional e.g., smoking, diabetes, family history / non-traditional e.g., pre-eclampsia, chronic inflammatory conditions, premature menopause), examination at baseline (e.g. weight, height, body mass index), medications at baseline and on discharge, presentation, triggers, investigations (including multimodality imaging, coronary angiography, echocardiogram), management (including revascularisation) and in-hospital outcomes.
Available in-hospital pathology results that have already been performed as part of standard care, including serum creatinine and electrolytes, liver function, full blood count, high sensitivity C-reactive protein (hs-CRP), fasting lipids and lipid biomarkers (e.g. TC, LDL, HDL, triglycerides) and diabetic profiles, will be collected.

The follow-up will be largely electronic by participants receiving an email link to a secure survey generated by the REDCap database that assesses self-reported outcomes. Telephone contact will be performed when required by each site if participants are unable to complete the survey. This will be with the use of telephone interpreters as needed for those of Non-English speaking backgrounds, and hospital/medical records obtained to clarify diagnoses, as required. Thirty day follow up will include a Quality of Life (QoL) assessment using the EQ-5D questionnaire. Clinical outcomes will be total and cardiac mortality, myocardial infarction recurrence, major adverse cardiovascular events (MACE) and major adverse cardiac and cerebrovascular events (MACCE).
Intervention code [1] 326530 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335385 0
Major adverse cardiovascular and Cerebrovascular events (MACCE) and all-cause of death
Timepoint [1] 335385 0
All data (from 2010 to 2023) will be collected at Baseline and last date of follow up or death taken from available medical records. Information is also collected from study questionnaires specifically designed for this study at 30d, 1 yr, 2 yr, 3 yr and 4 yr post- study enrolment. This is a composite outcome.
Secondary outcome [1] 424240 0
Occurrence of recurrent Myocardial infarction.
Timepoint [1] 424240 0
All data (from 2010 to 2023) will be collected at Baseline and last date of follow up or death taken from available medical records. Information is also collected from study questionnaires specifically designed for this study at 30d, 1 yr, 2 yr, 3 yr and 4 yr post- study enrolment.
Secondary outcome [2] 426818 0
Occurrence of recurrent repeat revascularisation.
Timepoint [2] 426818 0
All data (from 2010 to 2023) will be collected at Baseline and last date of follow up or death taken from available medical records. Information is also collected from study questionnaires specifically designed for this study at 30d, 1 yr, 2 yr, 3 yr and 4 yr post- study enrolment.
Secondary outcome [3] 426819 0
Occurrence of stroke/TIA
Timepoint [3] 426819 0
All data (from 2010 to 2023) will be collected at Baseline and last date of follow up or death taken from available medical records. Information is also collected from study questionnaires specifically designed for this study at 30d, 1 yr, 2 yr, 3 yr and 4 yr post- study enrolment.
Secondary outcome [4] 426820 0
Occurrence of all-cause mortality
Timepoint [4] 426820 0
All data (from 2010 to 2023) will be collected at Baseline and last date of follow up or death taken from available medical records. Information is also collected from study questionnaires specifically designed for this study at 30d, 1 yr, 2 yr, 3 yr and 4 yr post- study enrolment.
Secondary outcome [5] 426821 0
Occurence of bleeding
Timepoint [5] 426821 0
All data (from 2010 to 2023) will be collected at Baseline and last date of follow up or death taken from available medical records. Information is also collected from questionnaires specifically designed for this study at 30d, 1 yr, 2 yr, 3 yr and 4 yr post- study enrolment.
Secondary outcome [6] 426822 0
Occurrence of cardiovascular death
Timepoint [6] 426822 0
All data (from 2010 to 2023) will be collected at Baseline and last date of follow up or death taken from available medical records. Information is also collected from study questionnaires specifically designed for this study at 30d, 1 yr, 2 yr, 3 yr and 4 yr post- study enrolment.

Eligibility
Key inclusion criteria
Patients aged =>18 years and <50 years old with acute myocardial infarction (MI)
Type 1 and Type 2 MI are both included, with MI defined according to the 4th universal definition.
Clinical evidence of acute myocardial ischaemia and detection of a rise and/or fall of cTroponin values with at least 1 value above the 99th percentile upper reference limit and, at least one of the following:
1. Symptoms of myocardial ischaemia;
2. New ischaemic ECG changes;
3. Development of pathological Q waves;
4. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischaemic aetiology;
5. Identification of a coronary thrombus by angiography or autopsy
6. Patients must have undergone coronary angiography.
7. Patients must be able to provide informed consent.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Rise in cardiac biomarkers and/or ECG changes due to a clear non-coronary artery pathology e.g. myocarditis, acute arrhythmia, cardiomyopathy, acute pulmonary embolism (PE), stroke, recent cardiac surgery (these can all cause ischaemic changes on the ECG and/or troponin rises)
• Patients with presumed MI who die before the diagnosis has been confirmed by troponin values or coronary angiography (Type 3 MI)
• Percutaneous coronary intervention (PCI)-related MI (Type 4 MI)
• Coronary artery bypass grafting (CABG)-related MI (Type 5 MI)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Categorical variables will be summarised using frequencies and percentages with associations being analysed using chi- squared or Fisher exact tests as appropriate. Continuous variables will be analysed with a t-test and expressed as mean and standard deviation. A P<0.05 will be considered statistically significant for all analyses. Statistical analyses will be performed using SPSS or SAS, as required. Outcomes and presentation variables will be compared by sex. Westmead Hospital Cardiology Department already collects data on all patients with ST-elevation MIs admitted through Westmead Hospital and enters the data into a Redcap Database

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/09/2023
Date of last participant enrolment
Anticipated
31/07/2027
Actual
Date of last data collection
Anticipated
31/07/2031
Actual
Sample size
Target
500
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25185 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 40855 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 314295 0
Government body
Name [1] 314295 0
NSW Health
Country [1] 314295 0
Australia
Funding source category [2] 314296 0
Charities/Societies/Foundations
Name [2] 314296 0
National Heart Foundation of Australia
Country [2] 314296 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Western Sydney Local Health District Cnr Hawkesbury Road and Darcy Road Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 316238 0
None
Name [1] 316238 0
Address [1] 316238 0
Country [1] 316238 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313410 0
Western Sydney Local Health District
Ethics committee address [1] 313410 0
Westmead Hospital Cnr Hawkesbury Road and Darcy Road Westmead NSW 2145
Ethics committee country [1] 313410 0
Australia
Date submitted for ethics approval [1] 313410 0
04/04/2023
Approval date [1] 313410 0
12/06/2023
Ethics approval number [1] 313410 0
2023_ETH00713

Summary
Brief summary
Myocardial infarction (MI) affects -57,000 Australians every year and almost half a million Australians have had a heart attack at some point in their lives. While mortality after MI has been declining over the last few decades, it is in the group of young patients that it has lagged. Data on the biological and pathophysiological factors related to MI in the young is scarce. In addition, there are gaps in quality of care due to the perceived risk for MI being low.
The study aims to characterise the clinical presentation, risk factors, angiography findings,
underlying aetiology, quality of care and sex differences, of young patients with MI (age <50 years).
This is an investigator-initiated, observational, single-centre clinical registry study. Approximately 500 patients under the age of 50 years with MI will be either recruited Prospectively from Westmead Hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128058 0
A/Prof Sarah Zaman
Address 128058 0
Westmead Applied Research Centre (WARC) Level 6, Block K, Entrance 10, Westmead Hospital 176 Hawkesbury Rd, Westmead NSW 2145
Country 128058 0
Australia
Phone 128058 0
+61 401752322
Fax 128058 0
Email 128058 0
sarah.zaman@sydney.edu.au
Contact person for public queries
Name 128059 0
Ms Swetha Perera
Address 128059 0
Westmead Applied Research Centre (WARC) Level 6, Block K, Entrance 10, Westmead Hospital 176 Hawkesbury Rd, Westmead NSW 2145
Country 128059 0
Australia
Phone 128059 0
+61 412449645
Fax 128059 0
Email 128059 0
swetha.perera@sydney.edu.au
Contact person for scientific queries
Name 128060 0
Ms Swetha Perera
Address 128060 0
Westmead Applied Research Centre (WARC) Level 6, Block K, Entrance 10, Westmead Hospital 176 Hawkesbury Rd, Westmead NSW 2145
Country 128060 0
Australia
Phone 128060 0
+61 412449645
Fax 128060 0
Email 128060 0
swetha.perera@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data of published results can be obtained by contacting the primary investigator (A/Prof. Sarah Zaman), with any reasonable requests for the purpose of research considered.
When will data be available (start and end dates)?
Analysis will be performed at the end of the study Dec 2028. Data will be available (15years
from end of study).
Available to whom?
Published in medical journals and the main findings disseminated to participants who enrolled in the study.
Available for what types of analyses?
Any purpose, only to achieve the aims in the study protocol
How or where can data be obtained?
Results can be obtained by contacting the primary investigator, with any reasonable requests for the purpose of research considered.
Name: A/Prof. sarah zaman
Email: Sarah.Zaman@sydney.edu.au


What supporting documents are/will be available?

No Supporting Document Provided



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.