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No Reflow Phenomenon Incidence and Predictors

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04017169
Acronym
NORM-PPCI
Enrollment
176
Registered
2019-07-12
Start date
2015-10-29
Completion date
2017-09-01
Last updated
2019-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No Reflow Phenomenon, STEMI

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.

Interventions

Sponsors

Hull University Teaching Hospitals NHS Trust
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Incidence of no reflow phenomenon0-2 days

Secondary

MeasureTime frameDescription
Predictors of no reflow phenomenon0-3 daysStatistical analysis of multiple variables to find independent predictors
MACE outcomes30 days* Cardiovascular death * Death * Hearth Failure (Killip class III/IV) * MI * CVA * Repeat unplanned angiography * Repeat unplanned revascularisation

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026