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

NCT02788396 | Completed

• 1 other identifier: B853
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

ST-elevation Myocardial Infarction (STEMI)

Keywords

STEMI; PPCI; post-dilatation; coronary microcirculation

Outcome Measures

Primary Outcomes (1)

• Delta index of microcirculatory resistance (dIMR)

  Delta index of microcirculatory resistance (dIMR) \[dΙΜΡ = IMR post post-dilation (post IMR) - IMR pre post-dilation (pre IMR)\]

  index procedure

Secondary Outcomes (5)

• Minimum stent area (MSA)

  index procedure

• Stent expansion

  index procedure

• Stent mal-apposition

  index procedure

• Intra-stent plaque protrusion and thrombus

  index procedure

• Stent edge dissections

  index procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

STEMI patients undergoing PPCI

You may qualify if:

• \>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)

You may not qualify if:

• \< 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)

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead
• Anglia Ruskin University: collaborator

Study Sites (1)

The Essex Cardiothoracic Centre

Basildon, Essex, SS16 5NL, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32329200 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• John R Davies, MD PhD

  Mid and South Essex NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 2, 2016
• Study Start: May 1, 2016
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)