No Reflow Phenomenon Incidence and Predictors
- Conditions
- No Reflow PhenomenonSTEMI
- Registration Number
- NCT04017169
- Lead Sponsor
- Hull University Teaching Hospitals NHS Trust
- Brief Summary
Background No reflow phenomenon is described in up to 65% of patients undergoing primary percutaneous coronary intervention for ST elevation myocardial infarction (STEMI). It is known to be associated with worse outcomes but predictors of no reflow are not clearly described.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
- Age ≥ 18 years
- Presenting with ST elevation myocardial infarction
- Appropriate for Primary Percutaneous Coronary Intervention
- Primary Percutaneous Coronary Intervention not performed eg due to non- flow- limiting coronary artery disease
- Unsuccessful PCI
- Thrombolysis
- Patients who do not survive the procedure to leave the catheterisation laboratory
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of no reflow phenomenon 0-2 days
- Secondary Outcome Measures
Name Time Method Predictors of no reflow phenomenon 0-3 days Statistical analysis of multiple variables to find independent predictors
MACE outcomes 30 days * Cardiovascular death
* Death
* Hearth Failure (Killip class III/IV)
* MI
* CVA
* Repeat unplanned angiography
* Repeat unplanned revascularisation
Trial Locations
- Locations (1)
Castle Hill Hospital (Hull and east Yorkshire Hospitals NHS Trust)
🇬🇧Cottingham, East Yorkshire, United Kingdom
Castle Hill Hospital (Hull and east Yorkshire Hospitals NHS Trust)🇬🇧Cottingham, East Yorkshire, United Kingdom