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  • Rationale and design of the PRognostic Importance of MIcrovascular Dysfunction in asymptomatic patients with Aortic Stenosis (PRIMID-AS): a multicentre observational study with blinded investigations

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Cardiovascular medicine
Protocol
Rationale and design of the PRognostic Importance of MIcrovascular Dysfunction in asymptomatic patients with Aortic Stenosis (PRIMID-AS): a multicentre observational study with blinded investigations
  1. Anvesha Singh1,
  2. Ian Ford2,
  3. John P Greenwood3,
  4. Jamal N Khan1,
  5. Akhlaque Uddin3,
  6. Colin Berry4,
  7. Stefan Neubauer5,
  8. Bernard Prendergast5,
  9. Michael Jerosch-Herold6,
  10. Bryan Williams7,
  11. Nilesh J Samani1,
  12. Gerry P McCann1
  1. 1Department of Cardiovascular Sciences, University of Leicester, Glenfield Hospital, Leicester, UK and NIHR Leicester Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester, UK
  2. 2Roberston Centre for Biostatistics, University of Glasgow, Glasgow, UK
  3. 3Multidisciplinary Cardiovascular Research Centre & The Division of Cardiovascular and Diabetes Research, Leeds Institute of Genetics, Health & Therapeutics, Leeds University, Leeds, UK
  4. 4Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK
  5. 5Department of Cardiovascular Sciences, University of Oxford, Oxford, UK
  6. 6Brigham and Woman's Hospital and Harvard Medical School, Boston, Massachusetts, USA
  7. 7Department of Cardiovascular Sciences, University College London, London, UK
  1. Correspondence to Dr Gerry P McCann; as707{at}le.ac.uk

Abstract

Introduction Aortic stenosis (AS) is the commonest valve disorder in the developed world requiring surgery. Surgery in patients with severe asymptomatic AS remains controversial. Exercise testing can identify asymptomatic patients at increased risk of death and symptom development, but with limited specificity, especially in older adults. Cardiac MRI (CMR), including myocardial perfusion reserve (MPR) may be a novel imaging biomarker in AS.

Aims (1) To improve risk stratification in asymptomatic patients with AS and (2) to determine whether MPR is a better predictor of outcome than exercise testing and brain natriuretic peptide (BNP).

Method/design Multicentre, prospective observational study in the UK, comparing MPR with exercise testing and BNP (with blinded CMR analysis) for predicting outcome.

Population 170 asymptomatic patients with moderate-to-severe AS, who would be considered for aortic valve replacement (AVR).

Primary outcome Composite of: typical symptoms necessitating referral for AVR and major adverse cardiovascular events. Follow-up: 12–30 months (minimum 12 months).

Primary hypothesis MPR will be a better predictor of outcome than exercise testing and BNP.

Ethics/dissemination The study has full ethical approval and is actively recruiting patients. Data collection will be completed in November 2014 and the study results will be submitted for publication within 6 months of completion.

ClinicalTrials.gov identifier NCT01658345.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

https://doi.org/10.1136/bmjopen-2013-004348

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