ST-elevation Myocardial Infarction (STEMI) Clinical Trial
— POSTDILSTEMIOfficial 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)
NCT number | NCT02788396 |
Other study ID # | B853 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2016 |
Est. completion date | May 31, 2018 |
Verified date | August 2021 |
Source | Mid and South Essex NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Essex Cardiothoracic Centre | Basildon | Essex |
Lead Sponsor | Collaborator |
---|---|
Mid and South Essex NHS Foundation Trust | Anglia Ruskin University |
United Kingdom,
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 |
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