No Reflow Phenomenon Incidence and Predictors (NORM-PPCI)

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

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 Overview

• Status: Completed
• Conditions: STEMI; No Reflow Phenomenon
• Intervention / Treatment: Other: No intervention as observational study

• Study Type: Observational
• Enrollment (Actual): 176

Contacts and Locations

Study Locations

• United Kingdom
  • East Yorkshire
    • Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
      • Castle Hill Hospital (Hull and east Yorkshire Hospitals NHS Trust)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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
No NRP; Normal angiographic coronary flow/blush post patent culprit vessel.	Other: No intervention as observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hull University Teaching Hospitals NHS Trust
• Investigators: Principal Investigator: Jennifer A Rossington, BSc MBChB, Hull University Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2015
• Primary Completion (Actual): May 31, 2016
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): July 29, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; No-Reflow Phenomenon
• Other Study ID Numbers: NORM PPCI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No