Barts Revascularisation Registry

Myocardial Infarction Clinical Trial

Official title:

Barts Revascularisation Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255705
• Other study ID #: EDGE ID: 142567
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: March 1, 2026

Study information

• Verified date: October 2022
• Source: Queen Mary University of London
• Contact: Dr. Krishnaraj Rathod
• Phone: 02073773000
• Email: krishnaraj.rathod1[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angina, Stable
• Infarction
• Myocardial Infarction
• Stable Angina

Intervention

Other:
• Observation only
Observation only

Locations

Country	Name	City	State
United Kingdom	Barts Health NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Assessment of Mortality	1 year
Primary	Re-admission rates post Revascularisation	Re-admission	1 year
Primary	MACE post Revascularisation	MACE	1 year