NORM-PPCI: No Reflow Phenomenon Incidence and Predictors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: No intervention as observational study
|
| No NRP Normal angiographic coronary flow/blush post patent culprit vessel. |
Other: No intervention as observational study
|
Outcome Measures
Primary Outcome Measures
- Incidence of no reflow phenomenon [0-2 days]
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18 years
-
Presenting with ST elevation myocardial infarction
-
Appropriate for Primary Percutaneous Coronary Intervention
Exclusion Criteria:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Castle Hill Hospital (Hull and east Yorkshire Hospitals NHS Trust) | Cottingham | East Yorkshire | United Kingdom | HU16 5JQ |
Sponsors and Collaborators
- Hull University Teaching Hospitals NHS Trust
Investigators
- Principal Investigator: Jennifer A Rossington, BSc MBChB, Hull University Teaching Hospitals NHS Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NORM PPCI