The Essex Cardiothoracic Centre
Basildon, Essex, SS16 5NL, United Kingdom
NCT Number: NCT02788396
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).
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Notify Me18 year and older
All sexes
Observational
Basildon, Essex, SS16 5NL, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: index procedure
Delta index of microcirculatory resistance (dIMR) [dΙΜΡ = IMR post post-dilation (post IMR) - IMR pre post-dilation (pre IMR)]
Time frame: index procedure
Pre and post dilatation minimum stent area
Time frame: index procedure
Pre and post dilatation stent expansion; defined as the minimum stent area divided by the average of proximal and distal reference lumen areas x 100
Time frame: index procedure
Stent mal-apposition pre and post dilatation; defined as a distance between the strut's luminal edge and luminal vessel wall of greater >200 μm for a length >600 μm (appreciable in >3 contiguous frames at a pull-back speed of 20 mm/sec
Time frame: index procedure
Pre and post dilatation intra-stent plaque protrusion and thrombus; defined as a mass attached to the luminal surface or floating within the lumen at least 200 μm beyond the luminal edge of a strut
Time frame: index procedure
Edge dissections pre and post dilatation, further defined as major and minor [major dissections defined as the ones with a dissection flap width greater or equal to 200 μm)
Mid and South Essex NHS Foundation Trust
Other
The Impact of Post Stenting Balloon Dilatation on Coronary Microcirculation in ST Segment Elevation Myocardial Infarction (STEMI) Patients Undergoing Primary Percutaneous Coronary Intervention (PPCI)
Acronym: POSTDILSTEMI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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