Barts Revascularisation Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Stable Angina
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 20000

Contacts and Locations

• Study Contact: Name: Dr. Krishnaraj Rathod; Phone Number: 02073773000; Email: krishnaraj.rathod1@nhs.net
• Study Contact Backup: Name: Dr. Daniel Jones; Phone Number: 02073777000; Email: dan.jones8@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Barts Health Nhs Trust
    • Contact: Dr Krishnaraj Rathod

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will include all patients admitted to or reviewed at Barts Heart Centre (St. Bartholomew's Hospital) who undergo revascularisation. 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Assessment of Mortality	1 year
Re-admission rates post Revascularisation	Re-admission	1 year
MACE post Revascularisation	MACE	1 year

Collaborators and Investigators

• Sponsor: Queen Mary University of London

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): March 1, 2026
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Myocardial Infarction; Infarction; Angina, Stable
• Other Study ID Numbers: EDGE ID: 142567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No