Barts Revascularisation Registry

Sponsor
Queen Mary University of London (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05255705
Collaborator
(none)
20,000
1
48
416.7

Study Details

Study Description

Brief Summary

Despite the year-on-year decrease, coronary artery disease (CAD) still remains one of the leading cause 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.

This data will add to that literature by assessing the characteristics and outcomes of patients with CAD. It will also identify and characterise predictors of outcomes, improve risk stratification and diagnostic evaluation.

Condition or Disease Intervention/Treatment Phase
  • Other: Observation only

Detailed Description

The collection of data to describe the nationwide practice of percutaneous coronary intervention (PCI) in the UK started with the inception of the British Cardiovascular Intervention Society (BCIS) in 1988. From 1988 to 1991 annual surveys of PCI activity were published in the British Heart Journal. Annual reports from 1992 onwards are available for download from the society's website (http://www.bcis.org.uk), and summaries of some of the key data have been published as reports for distribution to participating hospitals and networks. The initial data collection process was essentially a descriptive survey of activity. Over time the process has evolved becoming more sophisticated with electronic methods for data collection developed by the Central Cardiac Audit Database (CCAD) group. The methods were tested in 1996 as a pilot in selected hospitals, and full UK-wide participation in the electronic collection of PCI data was achieved by 2005.

The proposed study includes one of the largest coronary interventional and surgical 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 undergoing PCI and CABG 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 hypothesis 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Barts Revascularisation Registry
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Patients undergoing Revascularisation 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 coronary artery disease undergoing revascularisation.

Other: Observation only
Observation only

Outcome Measures

Primary Outcome Measures

  1. Mortality [1 year]

    Assessment of Mortality

  2. Re-admission rates post Revascularisation [1 year]

    Re-admission

  3. MACE post Revascularisation [1 year]

    MACE

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 had an angiogram at BHC.

  • Any patient who has undergone revascularisation.

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

Sponsors and Collaborators

  • Queen Mary University of London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT05255705
Other Study ID Numbers:
  • EDGE ID: 142567
First Posted:
Feb 24, 2022
Last Update Posted:
Feb 24, 2022
Last Verified:
Aug 1, 2021
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 Feb 24, 2022