Myocardial InfarctionNCT06040528
Early Discharge Pathway Registry
An observational study of Myocardial Infarction and ST Elevation Myocardial Infarction, run by Queen Mary University of London at 2 sites in United Kingdom.
Trial summary
Despite the year-on-year decrease, coronary artery disease (CAD) still remains one of the leading causes of mortality worldwide. With advances in technology and our understanding of cardiac disease, we can now treat CAD using minimally invasive interventional techniques. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction
- How many people
- 20,000 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 11 Nov 2023to 31 Dec 2026
- How long will I take part?
- 12 Months
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will include all patients admitted to or reviewed at Barts Heart Centre (St. Bartholomew's Hospital) who are discharged via the early discharge pathway. These patients range from young adults to the elderly and will include any patient ≥16 years of age. Patients who are followed up with and without any intervention (i.e. both medically managed patients as well as patients undergoing intervention) are equally as important and therefore we shall include both groups of patients. Patients will be included from referrals made by other clinicians either as in or outpatients. All these patients have their clinical data captured on a database or hospital based clinical programme.
Who may be able to join
- Informed consent will not be sought for, as patients are automatically included onto a database that we will use for research purposes. No children will be included in this study. Vulnerable adults or those unable to give consent will be included in the study as well if they are referred to the Interventional Cardiology team.
- Both male and female patients ≥16 years of age will be included
- All patients will have been admitted to BHC with acute coronary syndrome.
Who cannot join
- Patients <16 years will not be included in this study.
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
Barts Health NHS Trust
London
Dr. Daniel A Rathod, 02073777000, dan.jones8@nhs.net
Dr. Krishnaraj S Rathod, 02073777000, krishnaraj.rathod1@nhs.net
- Recruiting
Dr. Daniel Jones
London
Daniel A Jones, 02073777000, dan.jones8@nhs.net
Krishnaraj S Rathod, 02073777000, krishnaraj.rathod1@nhs.net
About this study
Official title: Barts Early Post-Acute Myocardial Infarction Discharge Registry
Despite the year-on-year decrease, coronary artery disease (CAD) still remains one of the leading causes of mortality worldwide. With advances in technology and our understanding of cardiac disease, we can now treat CAD using minimally invasive interventional techniques. This has revolutionised treatment for and improved the lives of many patients with CAD. Although trials have assessed various therapeutic strategies in various populations, real-world evidence of intervention and medical treatment among patients with CAD is increasingly recognised as an important part of providing safety and efficacy data and improving the care we provide.
Regional heart attack services have improved clinical outcomes following ST-segment elevation myocardial infarction (STEMI) by facilitating early reperfusion by primary percutaneous coronary intervention (PCI). Early discharge after primary PCI is welcomed by patients and increases the efficiency of health care.
This data will add to that literature by assessing the characteristics and outcomes of patients with CAD, concentrating on those who are discharged via the early discharge pathway. It will also identify and characterise predictors of outcomes, and improve risk stratification and diagnostic evaluation.
Read the detailed description
The proposed study includes one of the largest coronary interventional programmes in the UK at Europe's largest cardiac centre (BHC). This has allowed us to accumulate a large number of patients in just over 4 years. All patients admitted with acute coronary syndrome and discharged via the early discharge pathway are included in this study using a clinical database. The database is password-protected and includes demographic, clinical and outcome data.
The database includes patients with simple to complex CAD. We will use this database to test several hypotheses including but not limited to investigating characteristics of patients treated, complications of interventional treatment and outcomes of patients. This research will add substantially to the literature by providing real-world data from a leading coronary centre.
In this registry, we will assess the safety and feasibility of the EHD pathway for patients who were discharged after primary PCI from a high-volume heart attack centre in London.
The impact of this study will have local, regional and global consequences with an emphasis on investigating poorly studied areas (e.g. decompensated aortic stenosis) and providing evidence to improve their management and stimulate further research.
- Conditions
- Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients discharged on the Early Discharge Pathway at Barts Heart Centre | This study aims to assess, in a real-world setting, the safety, efficacy and feasibility of further investigations in patients with acute coronary syndrome who are admitted to Barts Heart Centre and are discharged via the early discharge pathway. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Titration of medication
To assess how medical therapy has been titrated in patients on the early discharge pathway
Measured: 1 year
Measurement of MACE
Assessment of MACE events in patients on the early discharge pathway
Measured: 1 year
Assessment of Quality of Life
Assess QoL using Questionnaire to assess change in symptoms at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start11 Nov 2023
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies 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
- 20,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040528
- Sponsor's protocol ID
- AWAIT
- Status last verified
- Feb 2026
- First submitted
- 22 Dec 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jones DA, Rathod KS, Howard JP, Gallagher S, Antoniou S, De Palma R, Guttmann O, Cliffe S, Colley J, Butler J, Ferguson E, Mohiddin S, Kapur A, Knight CJ, Jain AK, Rothman MT, Mathur A, Timmis AD, Smith EJ, Wragg A. Safety and feasibility of hospital discharge 2 days following primary percutaneous intervention for ST-segment elevation myocardial infarction. Heart. 2012 Dec;98(23):1722-7. doi: 10.1136/heartjnl-2012-302414. Epub 2012 Oct 10.
PubMed 23053711Jones DA, Rathod KS, Mathur A, Archbold RA. Discharge after primary percutaneous coronary intervention: the earlier the better? Eur Heart J Qual Care Clin Outcomes. 2022 May 5;8(3):229-231. doi: 10.1093/ehjqcco/qcab100. No abstract available.
PubMed 34951919Rathod KS, Comer K, Casey-Gillman O, Moore L, Mills G, Ferguson G, Antoniou S, Patel R, Fhadil S, Damani T, Wright P, Ozkor M, Das D, Guttmann OP, Baumbach A, Archbold RA, Wragg A, Jain AK, Choudry FA, Mathur A, Jones DA. Early Hospital Discharge Following PCI for Patients With STEMI. J Am Coll Cardiol. 2021 Dec 21;78(25):2550-2560. doi: 10.1016/j.jacc.2021.09.1379.
PubMed 34915986
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barts Early Post-Acute Myocardial Infarction Discharge Registry
- ClinicalTrials.gov ID
- NCT06040528
- Acronym / sponsor ID
- AWAIT
- Conditions
- Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Sep 2023 (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.
Despite the year-on-year decrease, coronary artery disease (CAD) still remains one of the leading causes of mortality worldwide. With advances in technology and our understanding of cardiac disease, we can now treat CAD using minimally invasive interventional techniques. This has revolutionised treatment for and improved the lives of many patients with CAD. Although trials have assessed various therapeutic strategies in various populations, real-world evidence of intervention and medical treatment among patients with CAD is increasingly recognised as an important part of providing safety and efficacy data and improving the care we provide.
Regional heart attack services have improved clinical outcomes following ST-segment elevation myocardial infarction (STEMI) by facilitating early reperfusion by primary percutaneous coronary intervention (PCI). Early discharge after primary PCI is welcomed by patients and increases the efficiency of health care.
This data will add to that literature by assessing the characteristics and outcomes of patients with CAD, concentrating on those who are discharged via the early discharge pathway. It will also identify and characterise predictors of outcomes, and improve risk stratification and diagnostic evaluation.
Detailed description
The proposed study includes one of the largest coronary interventional programmes in the UK at Europe's largest cardiac centre (BHC). This has allowed us to accumulate a large number of patients in just over 4 years. All patients admitted with acute coronary syndrome and discharged via the early discharge pathway are included in this study using a clinical database. The database is password-protected and includes demographic, clinical and outcome data.
The database includes patients with simple to complex CAD. We will use this database to test several hypotheses including but not limited to investigating characteristics of patients treated, complications of interventional treatment and outcomes of patients. This research will add substantially to the literature by providing real-world data from a leading coronary centre.
In this registry, we will assess the safety and feasibility of the EHD pathway for patients who were discharged after primary PCI from a high-volume heart attack centre in London.
The impact of this study will have local, regional and global consequences with an emphasis on investigating poorly studied areas (e.g. decompensated aortic stenosis) and providing evidence to improve their management and stimulate further research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients discharged on the Early Discharge Pathway at Barts Heart Centre | – | –This study aims to assess, in a real-world setting, the safety, efficacy and feasibility of further investigations in patients with acute coronary syndrome who are admitted to Barts Heart Centre and are discharged via the early discharge pathway. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will include all patients admitted to or reviewed at Barts Heart Centre (St. Bartholomew's Hospital) who are discharged via the early discharge pathway. These patients range from young adults to the elderly and will include any patient ≥16 years of age. Patients who are followed up with and without any intervention (i.e. both medically managed patients as well as patients undergoing intervention) are equally as important and therefore we shall include both groups of patients. Patients will be included from referrals made by other clinicians either as in or outpatients. All these patients have their clinical data captured on a database or hospital based clinical programme.
Key inclusion criteria (3 listed)
- Informed consent will not be sought for, as patients are automatically included onto a database that we will use for research purposes. No children will be included in this study. Vulnerable adults or those unable to give consent will be included in the study as well if they are referred to the Interventional Cardiology team.
- Both male and female patients ≥16 years of age will be included
- All patients will have been admitted to BHC with acute coronary syndrome.
Key exclusion criteria (1 listed)
- Patients <16 years will not be included in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Titration of medication
Time frame: 1 year
To assess how medical therapy has been titrated in patients on the early discharge pathway
Measurement of MACE
Time frame: 1 year
Assessment of MACE events in patients on the early discharge pathway
Assessment of Quality of Life
Time frame: 1 year
Assess QoL using Questionnaire to assess change in symptoms at 1 year
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 27 Feb 2026.
- Background: PubMed 23053711Jones DA, Rathod KS, Howard JP, Gallagher S, Antoniou S, De Palma R, Guttmann O, Cliffe S, Colley J, Butler J, Ferguson E, Mohiddin S, Kapur A, Knight CJ, Jain AK, Rothman MT, Mathur A, Timmis AD, Smith EJ, Wragg A. Safety and feasibility of hospital discharge 2 days following primary percutaneous intervention for ST-segment elevation myocardial infarction. Heart. 2012 Dec;98(23):1722-7. doi: 10.1136/heartjnl-2012-302414. Epub 2012 Oct 10.
- Background: PubMed 34951919Jones DA, Rathod KS, Mathur A, Archbold RA. Discharge after primary percutaneous coronary intervention: the earlier the better? Eur Heart J Qual Care Clin Outcomes. 2022 May 5;8(3):229-231. doi: 10.1093/ehjqcco/qcab100. No abstract available.
- Background: PubMed 34915986Rathod KS, Comer K, Casey-Gillman O, Moore L, Mills G, Ferguson G, Antoniou S, Patel R, Fhadil S, Damani T, Wright P, Ozkor M, Das D, Guttmann OP, Baumbach A, Archbold RA, Wragg A, Jain AK, Choudry FA, Mathur A, Jones DA. Early Hospital Discharge Following PCI for Patients With STEMI. J Am Coll Cardiol. 2021 Dec 21;78(25):2550-2560. doi: 10.1016/j.jacc.2021.09.1379.
- 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.
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 Myocardial Infarction and ST Elevation Myocardial Infarction, run by Queen Mary University of London 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 3 inclusion and 1 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 27 Feb 2026. 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?
Contact Dr. Daniel A Jones (02073777000, dan.jones8@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Titration of medication (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06040528, which also lists 3 linked publications.
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 27 Feb 2026.