Clinical trial NCT04218344: The Harefield Acute Myocardial Infarction Cohort
Official title: The Harefield Acute Myocardial Infarction Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndrome
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting to Harefield Hospital through the Primary Percutaneous Coronary Intervention programme

Brief summary: In this project the investigator's plan to collect blood during a patient's routine angiogram procedure which they will have due to having suffered a heart attack. Data from the patients' routine procedures for this condition, including but not exclusively, ECG, Echocardiogram, MRI scans, will be collected. The aim of the research project is to analyse the blood samples and identify novel biomarkers and clinical parameters associated with acute coronary syndromes. The investigator's will particularly focus on markers of inflammation and micro-organism activity. The investigator's hope that this will help to gain more knowledge about what causes heart disease and how various conditions can be treated more efficiently. The investigator's will follow-up and collect further research data via a questionnaire at the routine 6 weeks and 6 months follow-up appointment after the angiogram procedure. Participants will also be telephoned at one-year post procedure, to update any events and medication status and data will thereafter be collected form data held by the hospital without having to contact the participant. Remaining blood samples will be stored securely for further analysis into blood and other markers.

Detailed description: Acute coronary syndromes (ACS), i.e. patients presenting with ST-segment elevation myocardial infarction (STEMI), non ST-segment elevation myocardial infarction (non-STEMI) or unstable angina, are still a major cause of morbidity and mortality in the United Kingdom and beyond. In spite of the enormous progress made in the last decades, the in hospital mortality has plateaued recently, and the event rate after the infarction is still high with one in 8 patients having a second event (i.e. death, myocardial infarction, heart failure, revascularization among others) within a year of follow-up.

After the acute event, risk stratification is important and will be come even more sophisticated than it currently is with the advent of anatomic risk scores (SYNTAX II Score), novel biomarkers and novel drugs allowing for more precise characterization of the patients individual risk and more tailored secondary prevention strategies (Precision Medicine).

Indeed, particularly the upcoming treatment strategies with bio-logicals (i.e. monoclonal antibodies, e.g. against PCSK9) and genetic tools (i.e. RNA interference, antisense technology) will require precise risk assessment for cost-effective use of these promising new tools.

It is anticipated that this study will help the investigator's to describe the heart attack population in a robust manner with a wealth of clinical data as well as blood samples for bio-markers.

Eligibility criteria: Inclusion Criteria:

• All patients presenting to Harefield Hospital through the Primary Percutaneous Coronary Intervention programme, with ST-segment elevation myocardial infarction, non ST-segment elevation myocardial infarction, unstable angina, Tako Tsubo syndrome, spontaneous coronary artery dissection and acute myocarditis, with the intention to assess with coronary angiography.

Exclusion Criteria:

* Patients will be able to self-exclude if they do not provide full informed consent
* Every effort will be made to obtain informed consent from all patients.
* Patients who do not survive the hospital episode will undergo a Professional or Personal Consultee process of assumed consent.

Primary outcomes:
measure: To identify novel biomarkers and clinical parameters associated with acute coronary syndromes caused by coronary artery disease
timeFrame: 2 - 5 Years
Secondary outcomes:
measure: To define the patient population with Myocardial Infarction with Non-Obstructive Coronary Artery disease (MINOCA) and determine the individual risks of these patients (eg. TakoTsubo Syndrome and Acute Myocarditis).
timeFrame: 2 - 5 Years
measure: To explore the concept of personalised medicine for future patients, based on the identification of novel biomarkers.
timeFrame: 2 - 5 Years
Other outcomes:
Locations:
city: Harefield
country: United Kingdom
facility: Harefield Hospital
state: Middlesex
city: Uxbridge
country: United Kingdom
facility: Royal Brompton and Harefield NHS Foundation Trust
state: Middlesex
Study officials:
References: