The Harefield Acute Myocardial Infarction Cohort
HEART - ACS
1 other identifier
observational
2,000
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2020
CompletedFirst Posted
Study publicly available on registry
January 6, 2020
CompletedStudy Start
First participant enrolled
January 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2035
January 18, 2020
January 1, 2020
11 years
January 2, 2020
January 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
To identify novel biomarkers and clinical parameters associated with acute coronary syndromes caused by coronary artery disease
1. Inflammatory markers 2. Microbiome metabolites
2 - 5 Years
Secondary Outcomes (2)
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.
2 - 5 Years
Study Arms (2)
Acute Coronary Syndrome - Iscaemia
Patients who present with chest pain, undergo emergency angiogram and receive a cardiac stent.
Acute Coronary Syndrome - Non-Ischaemic
Patients who present with chest pain but angiography reveals normal coronary arteries.
Interventions
All patients presenting with a possible Acute Coronary Syndrome will be invited to donate 60 mls of blood at the time of their angiogram.
Eligibility Criteria
All patients presenting to Harefield Hospital through the Primary Percutaneous Coronary Intervention programme
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Harefield Hospital
Harefield, Middlesex, UB9 6JH, United Kingdom
Royal Brompton and Harefield NHS Foundation Trust
Uxbridge, Middlesex, UB9 6JH, United Kingdom
Biospecimen
Venous blood, 60mls per participant
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2020
First Posted
January 6, 2020
Study Start
January 9, 2020
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2035
Last Updated
January 18, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share