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Clinical Trials/NCT04017169
NCT04017169CompletedNot Applicable

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

Hull University Teaching Hospitals NHS Trust1 site in 1 country176 target enrollmentStarted: October 29, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
176
Locations
1
Primary Endpoint
Incidence of no reflow phenomenon

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Incidence of no reflow phenomenon

Time Frame: 0-2 days

Secondary Outcomes

  • Predictors of no reflow phenomenon(0-3 days)
  • MACE outcomes(30 days)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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