UNIVERSITY OF LEEDS: The Clinical Trials Research Unit (CTRU) at the Leeds Institute of Clinical Trials Research (LICTR), University of Leeds, believe that the cardiology community requires an appropri

Data-sharing agreement from NHS Digital registers of approved data releases, 2014–2019. Evidence status: source reported.

Organisation: University of Leeds
Source reference: DARS-NIC-04641-R3Y5V-v1.4
Jurisdiction: England
Licence: Open Government Licence v3.0, subject to NHS England terms and exclusions

Register reference: DARS-NIC-04641-R3Y5V-v1.4
Agreement period: not published to no end date published
For commercial purposes (as marked in the register): Not stated
Release files listed by NHS England: 4

Data approved

MRIS - Flagging Current Status Report
MRIS - Cause of Death Report
MRIS - Cohort Event Notification Report

Objective, as published

The Clinical Trials Research Unit (CTRU) at the Leeds Institute of Clinical Trials Research (LICTR), University of Leeds, believe that the cardiology community requires an appropriately powered, randomised controlled trial of non-invasive ischaemia assessment (functional imaging) to determine diagnosis and patient management. LICTR know that invasive angiography rates are already too high, and that they will increase further if the NICE guidelines (CG95) are followed. LICTR know that from a previous small single centre trial (CECaT), that using functional testing (Cardiac Magnetic Resonance Imaging (CMR), Single Photon Emission Computed Tomography (SPECT), stress echo) invasive angiography could be avoided in 20-25% of patients. LICTR also know that patients rightly want to avoid unnecessary angiography if at all possible, but to date no clinical trial has tested the safety of this type of strategy in terms of clinical outcome. LICTR propose the CE-MARC 2 trial, which would be a major advance from the simple and usually small diagnostic accuracy studies that are all too prevalent in the imaging literature. Having benchmarked the diagnostic performance of CMR and shown superiority against SPECT in the CE-MARC study, CTSU now propose to evaluate 3T CMR prospectively in a three-arm trial to assess whether a CMR-guided management strategy is superior to current best clinical practice (based upon either the principles of NICE CG95 or AHA SPECT appropriateness criteria. This type…

Expected benefits, as published

The results of the CEMARC 2 clinical research trial are expected to inform the next update of NICE guideline CG95 (Chest pain of recent onset: assessment and diagnosis) and therefore have enormous potential to change NHS practice, but also to inform future NHS capital expenditure. The research question is highly relevant to a large number of patients: what is the best initial test for patients coming to an outpatient clinic with chest pain that is suspected stable angina? It is well accepted that a variety of investigations may be used to diagnose Coronary Heart Disease and to determine the need for coronary revascularisation. Whilst the NICE guidelines (CG95) have provided a structured and evidence-based approach to the diagnosis of patients with chest pain, they are not without problems…

Source: https://webarchive.nationalarchives.gov.uk/ukgwa/2019/https://digital.nhs.uk/binaries/content/assets/website-assets/service/dars/release-registers/releaseregister20180301_20180524.xlsx. Captured 2026-10-30.

Limitations: Agreement as recorded in an NHS Digital register of approved data releases (2014–2019), retrieved from the UK Government Web Archive. That register lists releases made in its period and the agreement's purpose statement as it then stood; it gives no agreement dates, and the agreement may have changed since. Imported only where a paper quotes a reference no current register holds.