Study Results
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Basic Information
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COMPLETED
176 participants
OBSERVATIONAL
2015-10-29
2017-09-01
Brief Summary
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Objectives A single centre case-control observational study of patients presenting with acute myocardial infarction appropriate for PPCI comparing baseline clinical, biochemical and angiographic characteristics between patients with no reflow phenomenon and those without. Aiming to establish incidence for the UK population.
Secondary outcomes will be to gain further insight into those presenting with STEMI for PPCI and develop a risk model to guide management and clinical outcomes of patients to 30days.
Methods This study will prospectively recruit all consecutive patients attending a single centre for primary percutaneous coronary intervention for STEMI. Angiographic assessment of the recanalised epicardial vessel will be used to diagnose no reflow (reduced TIMI flow or blush grade). Baseline demographic, angiographic and biochemical characteristics and outcomes at 30days for reflow and no reflow cohorts will be statistically assessed and compared with logistic regression.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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No reflow phenomenon
Those that during procedure experience no reflow phenomenon
To define no reflow requires:
• Angiographic evidence of reopening of occluded coronary artery and successful stent placement with no evidence of flow-limiting residual stenosis (\<50%), dissection, vessel spasm, or thrombus burden
and
* Angiographic documentation of a TIMI flow grade ≤II, or
* A TIMI flow grade III with a myocardial perfusion grade 0 or I, at least 10 min after the end of PCI procedure.
No intervention as observational study
No NRP
Normal angiographic coronary flow/blush post patent culprit vessel.
No intervention as observational study
Interventions
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No intervention as observational study
Eligibility Criteria
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Inclusion Criteria
* Presenting with ST elevation myocardial infarction
* Appropriate for Primary Percutaneous Coronary Intervention
Exclusion Criteria
* Unsuccessful PCI
* Thrombolysis
* Patients who do not survive the procedure to leave the catheterisation laboratory
18 Years
ALL
No
Sponsors
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Hull University Teaching Hospitals NHS Trust
OTHER_GOV
Responsible Party
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Principal Investigators
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Jennifer A Rossington, BSc MBChB
Role: PRINCIPAL_INVESTIGATOR
Hull University Teaching Hospitals NHS Trust
Locations
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Castle Hill Hospital (Hull and east Yorkshire Hospitals NHS Trust)
Cottingham, East Yorkshire, United Kingdom
Countries
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Other Identifiers
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NORM PPCI
Identifier Type: -
Identifier Source: org_study_id
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