CEMARC 2 Coronary Microvascular Sub-Study.
Research type
Research Database
Full title
CEMARC 2 Coronary Microvascular SubStudy.
IRAS ID
125618
Contact name
Colin Berry
Contact email
Research summary
CEMARC 2 Coronary Microvascular Sub-Study.
REC name
West of Scotland REC 4
REC reference
13/WS/0204
Date of REC Opinion
7 Aug 2013
REC opinion
Favourable Opinion
Data collection arrangements
The data to be stored in this database will be de-identified clinical data for study participants in the CEMARC 2 trial. The main trial database will be held by the Leeds Leeds Clinical Trials & Research Unit (CTRU). We do not plan to replicate this database. Rather, we are supporting the CEMARC 2 trial with quality assurance analysis of the pressure wire-derived data i.e. fractional flow reserve (FFR), and related indices of coronary function (eg CFR, IMR, RRI). These data will be used for a sub-study and to this end, some of the CTRU clincial variables will be needed for a complete statistical analysises. These data will be clinical characteristics and the main results from the non-invasive tests, as well as the angiographic findings.
Research programme
(1) Quality assurance of the pressure-wire derived data (eg FFR, which drives the primary outcome of the study ie unncessary angiography). (2) CEMARC 2 coronary microvascular substudy (3) BHF Clincial Research Training Fellowship (PhD). (4) Linkage with other databases which contain similar information (eg MR INFORM trial NCT01236807; to be subject of future REC applications). (5) Electronic case record linkage (to be subject to future REC applications).
Research database title
CEMARC 2 Coronary Microvascular Sub-Study.
Establishment organisation
University of Glasgow; NHS Greater Glasgow & Clyde Health Board; NHS National Waiting Times Board
Establishment organisation address
BHF Glasgow Cardiovascular Research
Centre, 126 University Place
Glasgow
G128TA