No Reflow Phenomenon Incidence and Predictors

Study Overview
=================
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.

Official Title
-----------------
NO Reflow Phenomenon and Comparison to the Normal Flow Population Post Primary Percutaneous Coronary Intervention for ST Elevation Myocardial Infarction

Conditions
-----------------
No Reflow Phenomenon, STEMI

Intervention / Treatment
-----------------
* Other: No intervention as observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Presenting with ST elevation myocardial infarction Appropriate for Primary Percutaneous Coronary Intervention Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No reflow phenomenon<br>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<br> <br> |
| No NRP<br>Normal angiographic coronary flow/blush post patent culprit vessel. | Other: No intervention as observational study<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of no reflow phenomenon |  | 0-2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictors of no reflow phenomenon | Statistical analysis of multiple variables to find independent predictors | 0-3 days | 
| MACE outcomes | Cardiovascular death Death Hearth Failure (Killip class III/IV) MI CVA Repeat unplanned angiography Repeat unplanned revascularisation | 30 days |