Complete Versus Lesion-only Primary PCI pilot -Cardiac MRI sub study (CVLPRI-t-CMR)
Lead Research Organisation:
University Hospitals of Leicester NHS Trust
Department Name: UNLISTED
Abstract
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Technical Summary
Scientific Abstract|DESIGN: CVLPRI-t: Multi-centre, open, pilot, randomized, controlled clinical trial. CVLPRI-t-CMR: + blinded endpoint analysis|POPULATION: 250 patients with ST elevation myocardial infarction(MI) undergoing primary percutaneous angioplasty (P-PCI) with multi-vessel coronary artery disease.|INTERVENTION: Complete in-hospital revascularisation with PCI (infarct-related artery and major coronary vessels (> 2.0mm) with severe stenosis) and optimal medical therapy (OMT).|COMPARATOR: Infarct related P-PCI only with OMT. Further revascularisation for refractory angina despite OMT or ischaemic burden >20% of total myocardium on non-invasive imaging.|OUTCOME MEASURES: Main CULPRIT study: Major adverse cardiac events: all-cause death, recurrent MI, heart failure, need for revascularization (PCI or CABG) at 12 months|CMR substudy (BLINDED ENDPOINTS) Primary: 1. MI size (% of LV mass) on pre-discharge CMR. Secondary: 1. Myocardial salvage index, extent of microvascular obstruction, ejection fraction (EF) and left ventricular(LV) end diastolic(EDV) and systolic volumes(ESV), pre-discharge CMR. 2. LVEDV, ESV, EF and ischaemic burden on CMR at 9 months. |ASSESSMENT AND FOLLOW-UP: CMR will be performed pre-discharge (1-4 days) post MI and at 9 months. Clinical assessments for MACE at 3,6, 9 and 12 months (endpoints). |PROPOSED SAMPLE SIZE: It is anticipated the main study will recruit in total 250 patients. For the CMR study it is likely not all will be eligible/consent to CMR. 100 patients in each arm has 80% power to detect an absolute 4% difference in infarct size assuming infarct size 20 (10)% of LV mass, in culprit-only revascularisation, alpha=0.05 and 2-tailed.|STATISTICAL ANALYSIS: Analysis will be performed by a statistician from the CTEU at the Royal Brompton Hospital (supported by Imperial CTEU). Groups will be compared by 2 sample t-tests/Fishers exact test and Chi-square as appropriate and will be by intention to treat. Event free survival will be assessed by Kaplan-Meier curves. Univariate predictors of outcome will be assessed by logistic regression analysis and independent predictors by multivariate analysis. The trial will be overseen by a trial steering committee and an independent data and safety monitoring board with planned sub group analysis when 60 patients in each arm have been recruited.|PROJECT TIMETABLES AND RECRUITMENT RATE: The main CULPRIt clinical study without CMR has funding from the BHF. Ethics submission August 2010, recruitment starting in October 2010. It is anticipated that 6 patients per week (1.5/centre) will be recruited and completed within 9 months (June 2011) with a further follow-up of 12 months (June 2012) and 3 months for analysis/writing up (Sept. 2012). |
Publications
Shetye A
(2015)
Global myocardial strain assessment by different imaging modalities to predict outcomes after ST-elevation myocardial infarction: A systematic review.
in World journal of cardiology
McCann GP
(2015)
Complete Versus Lesion-Only Primary PCI: The Randomized Cardiovascular MR CvLPRIT Substudy.
in Journal of the American College of Cardiology
Khan JN
(2016)
Infarct Size Following Treatment With Second- Versus Third-Generation P2Y12 Antagonists in Patients With Multivessel Coronary Disease at ST-Segment Elevation Myocardial Infarction in the CvLPRIT Study.
in Journal of the American Heart Association
Khan JN
(2015)
Comparison of cardiovascular magnetic resonance feature tracking and tagging for the assessment of left ventricular systolic strain in acute myocardial infarction.
in European journal of radiology
Khan JN
(2016)
Relationship of Myocardial Strain and Markers of Myocardial Injury to Predict Segmental Recovery After Acute ST-Segment-Elevation Myocardial Infarction.
in Circulation. Cardiovascular imaging
Khan JN
(2014)
Prevalence and extent of infarct and microvascular obstruction following different reperfusion therapies in ST-elevation myocardial infarction.
in Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance
Khan JN
(2016)
Infarct size following complete revascularization in patients presenting with STEMI: a comparison of immediate and staged in-hospital non-infarct related artery PCI subgroups in the CvLPRIT study.
in Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance
Khan JN
(2017)
Cardiovascular magnetic resonance imaging assessment of outcomes in acute myocardial infarction.
in World journal of cardiology
Guideline Title | Choosing wisely ; ESC Guideline on management of STEMI |
Description | Choosing wisely- change of guidance |
Geographic Reach | North America |
Policy Influence Type | Citation in clinical guidelines |
URL | http://www.choosingwisely.org/doctor-patient-lists/american-college-of-cardiology |
Guideline Title | 2015 Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction |
Description | CvLPRIT change to clinical guidelines |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Citation in clinical guidelines |
Guideline Title | 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines |
Description | https://www-scopus-com.ezproxy4.lib.le.ac.uk/record/display.uri?eid=2-s2.0-85122075901&citeCnt=499_DELIM_499_DELIM_CTODS_1420195599_DELIM_1?igin=resultslist&sort=plf-f&refeid=2-s2.0-84924389903&src=s&imp=t&sid=e40b7c44b04bcdb511728c41515cdfc2&sot=ctocbw&sdt=a&sl=16&s=PUBYEAR+BEF+2024&relpos=1&citeCnt=2&searchTerm= |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Citation in clinical guidelines |
Impact | Adoption of this practice reduces length of stay and reduces risk of death and need for further procdedures by about half |
URL | https://www.jacc.org/doi/10.1016/j.jacc.2021.09.006 |
Description | Career Development Fellowship |
Amount | £951,690 (GBP) |
Funding ID | CDF-2014-07-045 |
Organisation | National Institute for Health Research |
Sector | Public |
Country | United Kingdom |
Start | 11/2014 |
End | 10/2018 |
Description | NIHR Research Professorship "Heart failure in type 2 diabetes: improving diagnosis and management in a multi-ethnic population. |
Amount | £1,943,967 (GBP) |
Funding ID | RP-2017-08-ST2-007 |
Organisation | National Institute for Health Research |
Sector | Public |
Country | United Kingdom |
Start | 11/2018 |
End | 11/2023 |
Description | Postdoctoral Fellowship |
Amount | £587,184 (GBP) |
Funding ID | 2011-04-51 |
Organisation | National Institute for Health Research |
Sector | Public |
Country | United Kingdom |
Start | 11/2011 |
End | 10/2014 |
Description | 25.10.17 PPI Engagement Talk at Leicester General Hospital (University Hospitals of Leicester) - Using MRI to Improve Heart Health |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | Local |
Primary Audience | Public/other audiences |
Results and Impact | -approximately 40 patients/carers attended a lay presentation on my research using MRI. Followed by 1 hour of discussion |
Year(s) Of Engagement Activity | 2017 |
Description | British Hypertenson Society Annual Scientific Meeting, Dublin - Oral Presentation "The BSCMR Research Group and multi-centre research in the UK |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Part of a research symposium at an annual scientific conference to educate the audience |
Year(s) Of Engagement Activity | 2016 |
URL | http://www.bihsoc.org |
Description | CV pathophsyiology symposium |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | Local |
Primary Audience | Postgraduate students |
Results and Impact | Talk generated discussion and ideas on how mRI may be useful in clinical and non-clinical studies increased requests for collaboration |
Year(s) Of Engagement Activity | 2014 |
Description | CVLPRIT CMR Site set-up |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | Regional |
Primary Audience | Health professionals |
Results and Impact | Got additional centres in to study- achieved target recruitment |
Year(s) Of Engagement Activity | 2011,2012 |
Description | Chair of a Cardiovascular Imaging Research Group Strategy Meeting at Glenfield Hospital/University of Leicester (virtual) |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | Local |
Primary Audience | Professional Practitioners |
Results and Impact | The purpose of these monthly meetings is to discuss the ongoing strategy with Professor McCann's research manager and senior members of his research team and share ideas which can then be cascaded down to postgrads/undergrads within the team. |
Year(s) Of Engagement Activity | 2020 |
Description | MDT Live |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Type Of Presentation | Keynote/Invited Speaker |
Geographic Reach | National |
Primary Audience | Health professionals |
Results and Impact | Case scenario discussion simulating clinical MDT meeting. Large clinical audience. I was selected based on my holding the current award and expertise in "Imaging) not known |
Year(s) Of Engagement Activity | 2012 |
Description | PPI oral presentation at Africal Caribbean Centre, Leics "Using MRI to improve cardiovascular health outcomes |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | Local |
Primary Audience | Public/other audiences |
Results and Impact | n/a |
Year(s) Of Engagement Activity | 2016 |
Description | South of England CMR Meeting 28.11.16 - lecture |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | Regional |
Primary Audience | Professional Practitioners |
Results and Impact | n/a |
Year(s) Of Engagement Activity | 2016 |
Description | University of Leicester PPI Inagural Lecture "Using MRI to improve cardiovascular health outcomes" |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | Regional |
Primary Audience | Professional Practitioners |
Results and Impact | Talk to the wider university and members of the public including family and friends on my research to date in 'lay language' |
Year(s) Of Engagement Activity | 2016 |