NCT06040528

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Nov 2023Dec 2026

First Submitted

Initial submission to the registry

December 22, 2022

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 11, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

December 22, 2022

Last Update Submit

February 26, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Assessment of Titration of medication

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

    1 year

  • Measurement of MACE

    Assessment of MACE events in patients on the early discharge pathway

    1 year

  • Assessment of Quality of Life

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

    1 year

Study Arms (1)

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.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Barts Health NHS Trust

London, United Kingdom

RECRUITING

Dr. Daniel Jones

London, United Kingdom

RECRUITING

Related Publications (3)

  • 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.

    PMID: 23053711BACKGROUND
  • Jones 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.

    PMID: 34951919BACKGROUND
  • Rathod 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.

    PMID: 34915986BACKGROUND

MeSH Terms

Conditions

Myocardial InfarctionST Elevation Myocardial InfarctionNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Dr. Daniel A Jones

CONTACT

Dr. Krishnaraj S Rathod

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2022

First Posted

September 15, 2023

Study Start

November 11, 2023

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations