No Reflow Phenomenon Incidence and Predictors

Completed

• Conditions: No Reflow Phenomenon; STEMI
• Interventions: Other: No intervention as observational study

• 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

Study Timeline

• Study Start: 2015-10-29
• Primary Completion: 2016-05-31
• Study Completion: 2017-09-01
• Study First Submitted: 2019-06-18
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-12
• Last Update Submitted: 2019-07-26
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No reflow phenomenon	No intervention as observational study	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 NRP	No intervention as observational study	Normal angiographic coronary flow/blush post patent culprit vessel.

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