CTP-PRO

  • Research type

    Research Study

  • Full title

    Impact of stress Cardiac computed Tomography myocardial Perfusion on downstream resources and PROgnosis in patients with suspected or known coronary artery disease: a multicenter international study - CTP-PRO Study

  • IRAS ID

    301010

  • Contact name

    Richard Crawley

  • Contact email

    richard.crawley@kcl.ac.uk

  • Sponsor organisation

    Centro Cardiologico Monzino, IRCCS

  • Clinicaltrials.gov Identifier

    NCT03976921

  • Duration of Study in the UK

    3 years, 4 months, 31 days

  • Research summary

    Coronary artery disease (CAD) is one of the main causes of death worldwide, defined as an interruption to the heart's blood supply. Computed Tomography Coronary Angiography (CTCA) is a first-line non-invasive diagnostic test in the UK to identify patients affected by CAD, as per NICE guidelines. However, a significant proportion of CTCA scans result in the identification of mild or moderate severity CAD; often leading to further functional tests to establish whether patients would benefit from invasive treatments, such as percutaneous coronary intervention or coronary artery bypass grafting.

    Cardiac CT perfusion imaging (CTP) is a newly developed technique, combining anatomical and functional imaging into a single modality. In previous clinical trials, combined CTCA/CTP has showed additional diagnostic value compared with CTCA alone.

    CTP-PRO is a multicentre, prospective, randomised-controlled trial evaluating the cost-effectiveness of a combined CTCA + CTP strategy versus alternative non-CT investigations in patients with suspected or known CAD referred for diagnostic evaluation.

    All participants recruited will be adult patients within the NHS with known CAD or intermediate-to-high risk of CAD. Consenting patients will be randomised into two groups (1:1 ratio):
    - Those within Group A will be investigated via CTCA. When CTCA demonstrates a significant coronary stenosis (>50% stenosis in one or more coronary arteries), the participants will progress to additional CTP imaging.
    - Those randomised to Group B will undergo an alternative non-CT-based investigation for CAD. As NICE guidelines recommend functional testing first-line in these patients, those within this arm are assumed to be within the ‘standard of care’.

    CTP-PRO is an international collaboration between research centres across Europe and the USA, assessing the potential for combined CTCA/CTP testing within multiple healthcare settings. At present, CTP is not performed routinely in the UK for investigation of CAD; this study presents a unique opportunity to evaluate this novel strategy within NHS patients.

  • REC name

    London - Bromley Research Ethics Committee

  • REC reference

    21/LO/0570

  • Date of REC Opinion

    23 Nov 2021

  • REC opinion

    Further Information Favourable Opinion