Early Discharge Pathway Registry

Sponsor
Queen Mary University of London (Other)
Overall Status
Recruiting
CT.gov ID
NCT06040528
Collaborator
(none)
20,000
2
72
10000
139

Study Details

Study Description

Brief 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. 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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
20000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Barts Early Post-Acute Myocardial Infarction Discharge Registry
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Assessment of Titration of medication [1 year]

    To assess how medical therapy has been titrated in patients on the early discharge pathway

  2. Measurement of MACE [1 year]

    Assessment of MACE events in patients on the early discharge pathway

  3. Assessment of Quality of Life [1 year]

    Assess QoL using Questionnaire to assess change in symptoms at 1 year

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

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.

Exclusion Criteria:

Patients <16 years will not be included in this study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Barts Health NHS Trust London United Kingdom
2 Dr. Daniel Jones London United Kingdom

Sponsors and Collaborators

  • Queen Mary University of London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT06040528
Other Study ID Numbers:
  • AWAIT
First Posted:
Sep 15, 2023
Last Update Posted:
Sep 15, 2023
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 15, 2023