No Reflow Phenomenon Incidence and Predictors

NCT04017169 | Completed

• 1 other identifier: NORM PPCI
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

No Reflow Phenomenon; STEMI

Outcome Measures

Primary Outcomes (1)

• Incidence of no reflow phenomenon

  0-2 days

Secondary Outcomes (2)

• Predictors of no reflow phenomenon

  0-3 days

• MACE outcomes

  30 days

Study Arms (2)

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

Interventions

No intervention as observational study OTHER

No NRP; No reflow phenomenon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18 years
• Presenting with ST elevation myocardial infarction
• Appropriate for Primary Percutaneous Coronary Intervention

You may not qualify if:

• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

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

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

MeSH Terms

Conditions

No-Reflow Phenomenon; ST Elevation Myocardial Infarction

Interventions

Observation

Condition Hierarchy (Ancestors)

Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Necrosis

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Jennifer A Rossington, BSc MBChB

  Hull University Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: July 12, 2019
• Study Start: October 29, 2015
• Primary Completion: May 31, 2016
• Study Completion: September 1, 2017
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)