No Reflow Phenomenon Incidence and Predictors

STEMI Clinical Trial

— NORM-PPCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04017169
• Other study ID #: NORM PPCI
• Status: Completed
• Start date: October 29, 2015
• Est. completion date: September 1, 2017

Study information

• Verified date: July 2019
• Source: Hull and East Yorkshire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: September 1, 2017
• Est. primary completion date: May 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• No Reflow Phenomenon
• No-Reflow Phenomenon
• ST Elevation Myocardial Infarction
• STEMI

Intervention

Other:
• No intervention as observational study

Locations

Country	Name	City	State
United Kingdom	Castle Hill Hospital (Hull and east Yorkshire Hospitals NHS Trust)	Cottingham	East Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Hull and East Yorkshire Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of no reflow phenomenon		0-2 days
Secondary	Predictors of no reflow phenomenon	Statistical analysis of multiple variables to find independent predictors	0-3 days
Secondary	MACE outcomes	Cardiovascular death; Death; Hearth Failure (Killip class III/IV); MI; CVA; Repeat unplanned angiography; Repeat unplanned revascularisation	30 days