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

ST-elevation Myocardial Infarction (STEMI) Clinical Trial

— POSTDILSTEMI  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02788396
• Other study ID #: B853
• Status: Completed
• Start date: May 1, 2016
• Est. completion date: May 31, 2018

Study information

• Verified date: August 2021
• Source: Mid and South Essex NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aneurysm
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-elevation Myocardial Infarction (STEMI)

Locations

Country	Name	City	State
United Kingdom	The Essex Cardiothoracic Centre	Basildon	Essex

Sponsors (2)

Lead Sponsor	Collaborator
Mid and South Essex NHS Foundation Trust	Anglia Ruskin University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta index of microcirculatory resistance (dIMR)	Delta index of microcirculatory resistance (dIMR) [d??? = IMR post post-dilation (post IMR) - IMR pre post-dilation (pre IMR)]	index procedure
Secondary	Minimum stent area (MSA)	Pre and post dilatation minimum stent area	index procedure
Secondary	Stent expansion	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	index procedure
Secondary	Stent mal-apposition	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	index procedure
Secondary	Intra-stent plaque protrusion and thrombus	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	index procedure
Secondary	Stent edge dissections	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)	index procedure