ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Cardiovascular

Coronary heart disease

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Major adverse cardiovascular and Cerebrovascular events (MACCE) and all-cause of death

Timepoint [1]

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]

Occurrence of recurrent Myocardial infarction.

Timepoint [1]

Secondary outcome [2]

Occurrence of recurrent repeat revascularisation.

Timepoint [2]

Secondary outcome [3]

Occurrence of stroke/TIA

Timepoint [3]

Secondary outcome [4]

Occurrence of all-cause mortality

Timepoint [4]

Secondary outcome [5]

Occurence of bleeding

Timepoint [5]

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]

Occurrence of cardiovascular death

Timepoint [6]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Westmead Hospital - Westmead

Recruitment postcode(s) [1]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NSW Health

Address [1]

NSW Ministry of Health 1 Reserve Road St Leonards NSW 2065 Australia

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

National Heart Foundation of Australia

Address [2]

Level 3,80 William Street Woolloomooloo NSW 2011

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney Local Health District

Ethics committee address [1]

Westmead Hospital Cnr Hawkesbury Road and Darcy Road Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/04/2023

Approval date [1]

12/06/2023

Ethics approval number [1]

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

A/Prof Sarah Zaman

Address

Westmead Applied Research Centre (WARC) Level 6, Block K, Entrance 10, Westmead Hospital 176 Hawkesbury Rd, Westmead NSW 2145

Country

Australia

Phone

+61 401752322

Fax

[email protected]

Contact person for public queries

Name

Swetha Perera

Address

Westmead Applied Research Centre (WARC) Level 6, Block K, Entrance 10, Westmead Hospital 176 Hawkesbury Rd, Westmead NSW 2145

Country

Australia

Phone

+61 412449645

Fax

[email protected]

Contact person for scientific queries

Name

Swetha Perera

Address

Westmead Applied Research Centre (WARC) Level 6, Block K, Entrance 10, Westmead Hospital 176 Hawkesbury Rd, Westmead NSW 2145

Country

Australia

Phone

+61 412449645

Fax

[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 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: [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.

Trial Review

Documents added manually

Documents added automatically