Clinical trial NCT02788396: The Impact of Post Stenting Balloon Dilatation on Coronary Microcirculation in STEMI Patients Undergoing PPCI
Official title: The Impact of Post Stenting Balloon Dilatation on Coronary Microcirculation in ST Segment Elevation Myocardial Infarction (STEMI) Patients Undergoing Primary Percutaneous Coronary Intervention (PPCI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ST-elevation Myocardial Infarction (STEMI)
Keywords: STEMI
PPCI
post-dilatation
coronary microcirculation
Lead sponsor: Mid and South Essex NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Anglia Ruskin University
First posted: 2016-06-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: STEMI patients undergoing PPCI

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.

Eligibility 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)

Primary outcomes:
measure: Delta index of microcirculatory resistance (dIMR)
timeFrame: index procedure
Secondary outcomes:
measure: Minimum stent area (MSA)
timeFrame: index procedure
measure: Stent expansion
timeFrame: index procedure
measure: Stent mal-apposition
timeFrame: index procedure
measure: Intra-stent plaque protrusion and thrombus
timeFrame: index procedure
measure: Stent edge dissections
timeFrame: index procedure
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: The Essex Cardiothoracic Centre
state: Essex
Study officials:
affiliation: Mid and South Essex NHS Foundation Trust
name: John R Davies, MD PhD
role: STUDY_CHAIR
References:
citation: Karamasis GV, Kalogeropoulos AS, Gamma RA, Clesham GJ, Marco V, Tang KH, Jagathesan R, Sayer JW, Robinson NM, Kabir A, Aggarwal RK, Kelly PA, Prati F, Keeble TR, Davies JR. Effects of stent postdilatation during primary PCI for STEMI: Insights from coronary physiology and optical coherence tomography. Catheter Cardiovasc Interv. 2021 Jun 1;97(7):1309-1317. doi: 10.1002/ccd.28932. Epub 2020 Apr 23.