The Harefield Acute Myocardial Infarction Cohort

NCT ID: NCT04218344

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-09
• Study Completion Date: 2035-12-31

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.

Conditions

Acute Coronary Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute Coronary Syndrome - Iscaemia

Patients who present with chest pain, undergo emergency angiogram and receive a cardiac stent.

60mls of blood donated for research analysis

Intervention Type: OTHER

All patients presenting with a possible Acute Coronary Syndrome will be invited to donate 60 mls of blood at the time of their angiogram.

Acute Coronary Syndrome - Non-Ischaemic

Patients who present with chest pain but angiography reveals normal coronary arteries.

60mls of blood donated for research analysis

Intervention Type: OTHER

All patients presenting with a possible Acute Coronary Syndrome will be invited to donate 60 mls of blood at the time of their angiogram.

Interventions

60mls of blood donated for research analysis

All patients presenting with a possible Acute Coronary Syndrome will be invited to donate 60 mls of blood at the time of their angiogram.

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Harefield Hospital

Harefield, Middlesex, United Kingdom

Site Status: RECRUITING

Royal Brompton and Harefield NHS Foundation Trust

Uxbridge, Middlesex, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Paula Rogers, RGN, BSc, MSc

Role: primary

p.rogers@rbht.nhs.uk

01895823737 ext. 83575

Claire Prendergast, RGN, BSc

Role: backup

c.prendergast2@rbht.nhs.uk

01895823737 ext. 83889

Miles Dalby, MRCP, MD

Role: primary

m.dalby@rbht.nhs.uk

01895823737 ext. 5990

Paula Rogers, BSc, MSc

Role: backup

p.rogers@rbht.nhs.uk

07753766189

Other Identifiers

IRAS ID - 25908

Identifier Type: -

Identifier Source: org_study_id