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The Impact of Post Stenting Balloon Dilatation on Coronary Microcirculation in STEMI Patients Undergoing PPCI | Clinical Trials | Clareo Health

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The Impact of Post Stenting Balloon Dilatation on Coronary Microcirculation in STEMI Patients Undergoing PPCI

The Impact of Post Stenting Balloon Dilatation on Coronary Microcirculation in ST Segment Elevation Myocardial Infarction (STEMI) Patients Undergoing Primary Percutaneous Coronary Intervention (PPCI)

NCT02788396•Mid and South Essex NHS Foundation Trust

View on ClinicalTrials.gov

Summary

This study aims to assess the impact of NC balloon post-dilatation on coronary microcirculation in patients with ST segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).

Detailed Description

Suboptimal stent deployment can lead to future stent failure. Thus, optimising stent deployment with non-compliant balloons (NC balloon) post dilatation (PD) at high pressures is an established strategy. In the context of ST segment elevation myocardial infarction (STEMI), PD has been correlated anecdotally with the no reflow phenomenon. This study aims to determine the impact of stent post-dilation (PD) with NC balloons at high pressures on coronary microcirculation during PPCI by measuring the index of microcirculatory resistance (IMR) pre and post stent post-dilatation. Pre and post PD, an optical coherence tomography (OCT) study will be performed to assess stent deployment and identify parameters that predict the changes in IMR.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•\>18 years of age
•Acute symptoms onset with duration \> 20 minutes
•ST-segment elevation ≥ 0.1 mV in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block
•Infarct related artery with a diameter above 2.5 mm
•Operator's intention to proceed to stent deployment (i.e. not refer for CABG or defer PCI)

Exclusion Criteria

•\< 18 year of age
•Symptoms duration \> 12 hours
•Unable to give informed consent
•Previous bypass graft surgery
•Previous myocardial infarction
•Pregnancy
•Known severe chronic kidney disease (creatinine clearance ≤30 mL/min), unless the patient is on dialysis
•Unable to receive antiplatelets or anticoagulation (i.e. coagulation disorders, bleeding etc.)
•Haemodynamic instability
•Severe LMS disease
+3 more criteria

Locations (1)

The Essex Cardiothoracic Centre

Basildon, Essex, United Kingdom

Key Dates

Start Date

May 1, 2016

Primary Completion Date

May 31, 2018

Completion Date

May 31, 2018

Last Updated

September 1, 2021

Enrollment

ACTUAL participants

Conditions

ST-elevation Myocardial Infarction (STEMI)

A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI

NCT04825743

ST-elevation Myocardial Infarction (STEMI)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 1, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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