None listed
Conditions
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.
Interventions
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).
Sponsors
Eligibility
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.
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)