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The Harefield Acute Myocardial Infarction Cohort

Sponsor: Royal Brompton & Harefield NHS Foundation Trust

NCT ID: NCT04218344

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
60mls of blood donated for research analysis (other)
How long the study runs
Study runs about 191 months (dates as stated)
About the drug or intervention
60mls of blood donated for research analysis — 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.
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
Not specified
Who
All
Number of participants
2,000
Started
2020-01-09
Last checked
2020-01

Plain English Summary

What is this study?

  • • Testing a new treatment for acute coronary syndrome
  • • Clinical study - 2,000 participants
  • • 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

Who can take part?

  • • Adults
  • • Diagnosed with acute coronary syndrome

Where?

  • • Harefield - Harefield Hospital
  • • Uxbridge - Royal Brompton and Harefield NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Acute Coronary Syndrome

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: Not specified
  • Who can join: All genders

Who cannot take part

  • ✗Patients will be able to self-exclude if they do not provide full agreement to take part
  • ✗Every effort will be made to obtain agreement to take part from all patients.
  • ✗Patients who do not survive the hospital episode will undergo a Professional or Personal Consultee process of...
See the full 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.

Where Is This Study? (2 UK sites)

Harefield Hospital

Harefield UB9 6JH, United Kingdom

Recruiting
Site contact (verified)
Paula Rogers, RGN, BSc, MSc01895823737p.rogers@rbht.nhs.uk
Claire Prendergast, RGN, BSc01895823737c.prendergast2@rbht.nhs.uk

Royal Brompton and Harefield NHS Foundation Trust

Uxbridge UB9 6JH, United Kingdom

Recruiting
Site contact (verified)
Miles Dalby, MRCP, MDPrincipal Investigator
Miles Dalby, MRCP, MD01895823737m.dalby@rbht.nhs.uk
Paula Rogers, BSc, MSc07753766189p.rogers@rbht.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2020-01