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OpenTrials
Completed

NCT Number: NCT04017169

No Reflow Phenomenon Incidence and Predictors

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Castle Hill Hospital (Hull and east Yorkshire Hospitals NHS Trust)

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention as observational study

Other

Primary outcomes

  1. Incidence of no reflow phenomenon

    Time frame: 0-2 days

Secondary outcomes

  1. Predictors of no reflow phenomenon

    Time frame: 0-3 days

    Statistical analysis of multiple variables to find independent predictors

  2. MACE outcomes

    Time frame: 30 days

    • Cardiovascular death
    • Death
    • Hearth Failure (Killip class III/IV)
    • MI
    • CVA
    • Repeat unplanned angiography
    • Repeat unplanned revascularisation

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Registry information

Official study title

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

Acronym: NORM-PPCI

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jul 12, 2019
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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