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

Completed

• Conditions: ST-elevation Myocardial Infarction (STEMI)

• Registration Number: NCT02788396
• Lead Sponsor: Mid and South Essex NHS Foundation Trust

Brief 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.

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2016-05-27
• Study First Submitted QC: 2016-05-27
• Study First Posted: 2016-06-02
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delta index of microcirculatory resistance (dIMR)	index procedure	Delta index of microcirculatory resistance (dIMR) \[dΙΜΡ = IMR post post-dilation (post IMR) - IMR pre post-dilation (pre IMR)\]

Secondary Outcome Measures

Name	Time	Method
Stent edge dissections	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)
Stent expansion	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
Minimum stent area (MSA)	index procedure	Pre and post dilatation minimum stent area
Stent mal-apposition	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
Intra-stent plaque protrusion and thrombus	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

Trial Locations

Locations (1)

The Essex Cardiothoracic Centre; 🇬🇧 Basildon, Essex, United Kingdom