Acute Coronary SyndromeHEART - ACSNCT04218344
The Harefield Acute Myocardial Infarction Cohort
An observational study of Acute Coronary Syndrome, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- 60mls of blood donated for research analysis
- How many people
- 2,000 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 9 Jan 2020to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients presenting to Harefield Hospital through the Primary Percutaneous Coronary Intervention programme
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Harefield Hospital
Harefield, Middlesex, UB9 6JH
Paula Rogers, RGN, BSc, MSc, 01895823737 ext. 83575, p.rogers@rbht.nhs.uk
Claire Prendergast, RGN, BSc, 01895823737 ext. 83889, c.prendergast2@rbht.nhs.uk
- Recruiting
Royal Brompton and Harefield NHS Foundation Trust
Uxbridge, Middlesex, UB9 6JH
Miles Dalby, MRCP, MD, 01895823737 ext. 5990, m.dalby@rbht.nhs.uk
Paula Rogers, BSc, MSc, 07753766189, p.rogers@rbht.nhs.uk
About this study
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.
Read the 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
- Being tested
- 60mls of blood donated for research analysis
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60mls of blood donated for research analysisOther
All patients presenting with a possible Acute Coronary Syndrome will be invited to donate 60 mls of blood at the time of their angiogram.
| Study group | Role | What they receive |
|---|---|---|
| Acute Coronary Syndrome - Iscaemia | Patients who present with chest pain, undergo emergency angiogram and receive a cardiac stent. Receives: Other: 60mls of blood donated for research analysis | |
| Acute Coronary Syndrome - Non-Ischaemic | Patients who present with chest pain but angiography reveals normal coronary arteries. Receives: Other: 60mls of blood donated for research analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify novel biomarkers and clinical parameters associated with acute coronary syndromes caused by coronary artery disease
- Inflammatory markers
- Microbiome metabolites
Measured: 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).
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).
Measured: 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.
Measured: 2 - 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start9 Jan 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218344
- Sponsor's protocol ID
- IRAS ID - 25908
- Acronym
- HEART - ACS
- Status last verified
- Jan 2020
- First submitted
- 2 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Harefield Acute Myocardial Infarction Cohort
- ClinicalTrials.gov ID
- NCT04218344
- Acronym / sponsor ID
- HEART - ACS / IRAS ID - 25908
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Coronary Syndrome - Iscaemia | – | Other: 60mls of blood donated for research analysisPatients who present with chest pain, undergo emergency angiogram and receive a cardiac stent. |
| Acute Coronary Syndrome - Non-Ischaemic | – | Other: 60mls of blood donated for research analysisPatients who present with chest pain but angiography reveals normal coronary arteries. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients presenting to Harefield Hospital through the Primary Percutaneous Coronary Intervention programme
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 60mls of blood donated for research analysisAll patients presenting with a possible Acute Coronary Syndrome will be invited to donate 60 mls of blood at the time of their angiogram. | Other | Acute Coronary Syndrome - Iscaemia, Acute Coronary Syndrome - Non-Ischaemic |
Primary outcome
To identify novel biomarkers and clinical parameters associated with acute coronary syndromes caused by coronary artery disease
Time frame: 2 - 5 Years
1. Inflammatory markers 2. Microbiome metabolites
2 secondary outcomes
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).
Time frame: 2 - 5 Years
To explore the concept of personalised medicine for future patients, based on the identification of novel biomarkers.
Time frame: 2 - 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Royal Brompton and Harefield NHS Foundation Trust
Uxbridge, United Kingdom
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify novel biomarkers and clinical parameters associated with acute coronary syndromes caused by coronary artery disease (time frame: 2 - 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020; AzTrials last refreshed its copy on 26 Oct 2026.