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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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
|
| |
| No NRP | Normal angiographic coronary flow/blush post patent culprit vessel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention as observational study | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of no reflow phenomenon | 0-2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Predictors of no reflow phenomenon | Statistical analysis of multiple variables to find independent predictors | 0-3 days |
| MACE outcomes |
|
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Inclusion Criteria:
Exclusion Criteria:
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The cohort is defined as all patients attending with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention. Cases are those subjects who suffered no reflow phenomenon, with control comparators those that had TIMI III flow and grade III myocardial blush post procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer A Rossington, BSc MBChB | Hull University Teaching Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Castle Hill Hospital (Hull and east Yorkshire Hospitals NHS Trust) | Cottingham | East Yorkshire | HU16 5JQ | United Kingdom |
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| ID | Term |
|---|---|
| D054318 | No-Reflow Phenomenon |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009203 | Myocardial Infarction |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| 30 days |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D009336 | Necrosis |