ST-elevation Myocardial Infarction (STEMI)
Conditions
Keywords
STEMI, PPCI, post-dilatation, coronary microcirculation
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.
Interventions
None listed
Sponsors
Anglia Ruskin University
Mid and South Essex NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Culprit vessel diameter \< 2.5 mm * Contraindications to adenosine * Any study lesion characteristic resulting in the expected inability to deliver OCT catheter to the lesion pre and post PD (e.g. moderate or severe vessel calcification or tortuosity)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Minimum stent area (MSA) | index procedure | Pre and post dilatation minimum stent area |
| 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 |
| 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 |
| 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) |
Countries
United Kingdom
Outcome results
None listed