The Harefield Acute Myocardial Infarction Cohort (HEART - ACS)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Other: 60mls of blood donated for research analysis

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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• United Kingdom
  • Middlesex
    • Harefield, Middlesex, United Kingdom, UB9 6JH
      • Recruiting
      • Harefield Hospital
      • Contact: Paula Rogers, RGN, BSc, MSc; Phone Number: 83575 01895823737; Email: p.rogers@rbht.nhs.uk
      • Contact: Claire Prendergast, RGN, BSc; Phone Number: 83889 01895823737; Email: c.prendergast2@rbht.nhs.uk
    • Uxbridge, Middlesex, United Kingdom, UB9 6JH
      • Recruiting
      • Royal Brompton and Harefield NHS Foundation Trust
      • Contact: Miles Dalby, MRCP, MD; Phone Number: 5990 01895823737; Email: m.dalby@rbht.nhs.uk
      • Contact: Paula Rogers, BSc, MSc; Phone Number: 07753766189; Email: p.rogers@rbht.nhs.uk
      • Principal Investigator: Miles Dalby, MRCP, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients presenting to Harefield Hospital through the Primary Percutaneous Coronary Intervention programme

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute Coronary Syndrome - Iscaemia; Patients who present with chest pain, undergo emergency angiogram and receive a cardiac stent.	Other: 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.
Acute Coronary Syndrome - Non-Ischaemic; Patients who present with chest pain but angiography reveals normal coronary arteries.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To identify novel biomarkers and clinical parameters associated with acute coronary syndromes caused by coronary artery disease	Inflammatory markers; Microbiome metabolites	2 - 5 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	2 - 5 Years
To explore the concept of personalised medicine for future patients, based on the identification of novel biomarkers.	To explore the concept of personalised medicine for future patients, based on the identification of novel biomarkers.	2 - 5 Years

Collaborators and Investigators

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Anticipated): December 31, 2030
• Study Completion (Anticipated): December 31, 2035

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Acute Coronary Syndrome
• Other Study ID Numbers: IRAS ID - 25908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No