Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001097639
Ethics application status
Approved
Date submitted
14/07/2023
Date registered
20/10/2023
Date last updated
20/10/2023
Date data sharing statement initially provided
20/10/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Myocardial Infarction in the Young: A Retrospective Clinical Registry Study
Scientific title
Myocardial Infarction in the Young: A Retrospective Clinical Registry Study
Secondary ID [1] 308429 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Young MI (Retrospective study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 328229 0
Condition category
Condition code
Cardiovascular 325280 325280 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
This is an investigator-initiated, observational, single-centre clinical registry study of young patients with myocardial infarction. At Westmead hospital, it is estimated (based on experience of the principal investigator) that every year, about 40 - 50 patients with Myocardial Infarction (MI) are 18-50 years of age. Therefore, from 2010 until now, approximately 500 patients with MI between 18-50 years can be recruited retrospectively (historical cases, no patient contact or ongoing follow up). Patients will be recruited via the medical records at Westmead Hospital.

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), 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 (TC, LDL, HDL, triglycerides) and diabetic profiles will be collected for all patients.

All patients aged 18-50 years, with a diagnosis of MI, who have undergone coronary angiography will be screened for with the help of the medical record department of Westmead hospital. A study coordinator will assess the patient’s medical records for eligibility criteria and confirm with the study investigator.

A waiver of consent will be used for patients recruited retrospectively in accordance with the National Statement on Ethical Conduct in Human Research (2.3.10). All data will be collected in a de-identified manner and last date of follow up or death taken from available medical records. Historical patients will be collected in a retrospective manner from 2010 to current study date (i.e., the last 12 years). Retrospectively recruited patients will not have ongoing follow up, Any data available at the time of recuritment will be collected with the date of last follow up or death taken from the available medical records. Participants will not be followed up.
Intervention code [1] 324879 0
Diagnosis / Prognosis
Comparator / control treatment
For each young patient recruited, an older patient (>50 years) who has MI in the same year will be randomly selected to act as control
Control group
Active

Outcomes
Primary outcome [1] 333139 0
Major adverse cardiovascular and Cerebrovascular events (MACCE) and all-cause of death
Timepoint [1] 333139 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. This is a composite outcome.
Secondary outcome [1] 415939 0
Occurrence of recurrent Myocardial infarction.
Timepoint [1] 415939 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
Secondary outcome [2] 415940 0
Occurrence of recurrent repeat revascularisation.
Timepoint [2] 415940 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
Secondary outcome [3] 415942 0
Occurrence of stroke/TIA data collected (from 2010 to 2023) at Baseline and last date of follow up or death taken from available medical records.
Timepoint [3] 415942 0
Information from hospital admission will be collected at Baseline and last date of follow up or death taken from available medical records.
Secondary outcome [4] 425711 0
Occurrence of all-cause mortality data collected (from 2010 to 2023) at Baseline and last date of follow up or death taken from available medical records.
Timepoint [4] 425711 0
Information from hospital admission will be collected at Baseline and last date of follow up or death taken from available medical records.
Secondary outcome [5] 426770 0
Occurrence of bleeding (from 2010 to 2023) at Baseline and last date of follow up or death taken from available medical records.
Timepoint [5] 426770 0
Information from hospital admission will be collected at Baseline and last date of follow up or death taken from available medical records.
Secondary outcome [6] 426771 0
Occurrence of cardiovascular death (from 2010 to 2023) at Baseline and last date of follow up or death taken from available medical records.
Timepoint [6] 426771 0
Information from hospital admission (from 2010 to 2023) will be collected at Baseline and last date of follow up or death taken from available medical records.

Eligibility
Key inclusion criteria
1. Patients aged =>18 years and <=50 years old with acute myocardial infarction (MI)
2. Patients aged >50 years and with acute myocardial infarction (MI) (control group)
2. 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:
a. Symptoms of myocardial ischaemia;
b. New ischaemic ECG changes;
c. Development of pathological Q waves;
d. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischaemic aetiology;
e. Identification of a coronary thrombus by angiography or autopsy

3. Participants must have undergone coronary angiography
Minimum age
18 Years
Maximum age
No limit
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
Duration
Selection
Timing
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. This has a Quality assurance approval. In brief, data is obtained on all baseline characteristics, demographics, medications, comorbidities, treatment and in-hospital outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/08/2023
Date of last participant enrolment
Anticipated
31/07/2027
Actual
Date of last data collection
Anticipated
31/07/2027
Actual
Sample size
Target
1000
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23576 0
Westmead Hospital - Westmead
Recruitment hospital [2] 24943 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 38998 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 312678 0
Government body
Name [1] 312678 0
NSW Health
Country [1] 312678 0
Australia
Funding source category [2] 314294 0
Charities/Societies/Foundations
Name [2] 314294 0
National Heart Foundation of Australia
Country [2] 314294 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Western Sydney Local Health DistrictCnr Hawkesbury Road and Darcy RoadWestmead NSW 2145
Country
Australia
Secondary sponsor category [1] 316237 0
None
Name [1] 316237 0
Address [1] 316237 0
Country [1] 316237 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311980 0
Western Sydney Local Health District
Ethics committee address [1] 311980 0
Ethics committee country [1] 311980 0
Australia
Date submitted for ethics approval [1] 311980 0
18/01/2023
Approval date [1] 311980 0
05/04/2023
Ethics approval number [1] 311980 0
2023_ETH00088

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

Contacts
Principal investigator
Name 123046 0
A/Prof Sarah Zaman
Address 123046 0
Westmead Applied Research Centre (WARC)
Level 6, Block K, Entrance 10, Westmead Hospital
176 Hawkesbury Rd, Westmead NSW 2145
Country 123046 0
Australia
Phone 123046 0
+61 401752322
Fax 123046 0
Email 123046 0
[email protected]
Contact person for public queries
Name 123047 0
Swetha Perera
Address 123047 0
Westmead Applied Research Centre (WARC)
Level 6, Block K, Entrance 10, Westmead Hospital
176 Hawkesbury Rd, Westmead NSW 2145
Country 123047 0
Australia
Phone 123047 0
+61 433510318
Fax 123047 0
Email 123047 0
[email protected]
Contact person for scientific queries
Name 123048 0
Swetha Perera
Address 123048 0
Westmead Applied Research Centre (WARC)
Level 6, Block K, Entrance 10, Westmead Hospital
176 Hawkesbury Rd, Westmead NSW 2145
Country 123048 0
Australia
Phone 123048 0
+61 433510318
Fax 123048 0
Email 123048 0
[email protected]

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 2027. Data will be available (15years from end of study).
Available to whom?
Published in medical journals and 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: [email protected]


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.