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

Mid and South Essex NHS Foundation Trust

Status

Completed

Conditions

ST-elevation Myocardial Infarction (STEMI)

Study type

Observational

Funder types

Other

Identifiers

NCT02788396

B853

Details and patient eligibility

About

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).

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)