Study of Deferred Versus Immediate Stenting in Acute STEMI Conventional Treatment With Immediate Stenting

This study has been completed.
Sponsor:
Collaborator:
British Heart Foundation
Information provided by (Responsible Party):
Prof. Keith G. Oldroyd, NHS National Waiting Times Centre Board
ClinicalTrials.gov Identifier:
NCT01851291
First received: May 5, 2013
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

The investigators propose a randomised study of deferred stenting in acute STEMI (for between 4-16 hours), once normal flow has been established (TIMI 3) with guide-wire, aspiration thrombectomy +/- small balloon, to assess whether this strategy might reduce the incidence of no-reflow compared to usual care and to make a preliminary assessment of the effects, if any, on clinical and surrogate outcomes.


Condition Intervention
ST-Elevation Myocardial Infarction
Procedure: Deferred stenting
Procedure: Conventional treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Study to Assess Whether Deferred Stenting in Acute STEMI Patients Might Reduce the Incidence of No-reflow Versus Conventional Treatment With Immediate Stenting

Resource links provided by NLM:


Further study details as provided by NHS National Waiting Times Centre Board:

Primary Outcome Measures:
  • Incidence of angiographic no-reflow - binary [ Time Frame: During either 1st or 2nd cath lab procedure ] [ Designated as safety issue: No ]
    Immediate group - no reflow during index cath lab procedure. Deferred group - no reflow during 2nd cath lab procedure


Secondary Outcome Measures:
  • Extent of late microvascular obstruction (MVO) assessed by cardiac MRI [ Time Frame: MRI 48 hours post reperfusion ] [ Designated as safety issue: No ]
  • Clinical events (hospitalisation for heart failure, re-infarction, cardiac death) [ Time Frame: 6-months ] [ Designated as safety issue: Yes ]
  • Degree of ST-segment resolution on ECG [ Time Frame: ECG in cath-lab prior to reperfusion and again 60 mins post-reperfusion ] [ Designated as safety issue: No ]
  • TIMI flow grade, corrected TIMI frame count, myocardial blush grade and intra-procedural thrombotic events [ Time Frame: During index cath lab procedure in immediate stenting group and during 2nd cath lab procedure in deferred stenting group ] [ Designated as safety issue: No ]
  • Culprit vessel dimensions (QCA) and thrombus burden [ Time Frame: Initial coronary angiogram (and 2nd angiogram in deferred group) ] [ Designated as safety issue: No ]
  • Change in LV ejection fraction, degree of adverse remodelling (end-systolic and end-diastolic volume index), final infarct size, myocardial salvage [ Time Frame: cardiac MRI 2 days and 6-months post PCI ] [ Designated as safety issue: No ]
  • Index of microvascular resistance (IMR) [ Time Frame: Immediately post-stenting in both groups ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: March 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Deferred stenting
During primary PCI in STEMI, once TIMI 3 flow has been achieved with guide-wire, aspiration thrombectomy +/- small balloon, stenting is then deferred for a period of 4-16 hours, and patients wait in CCU with administration of IV glycoprotein 2b3a infusion
Procedure: Deferred stenting
Sham Comparator: Conventional treatment
Conventional treatment in STEMI, with immediate stenting
Procedure: Conventional treatment
Other Name: Conventional treatment in STEMI, with immediate stenting

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

One of the following

  • Rescue PCI
  • Prolonged ischaemic time (> 12hours)
  • Previous MI
  • Age > 65
  • Occluded artery (TIMI 0/1) at initial angiography
  • Thrombus burden (TIMI grade 2+)
  • Long plaque/ stent length (> 24 mm)
  • Severe coronary artery disease (e.g calcified artery)
  • Small reference vessel diameter (< 2.5 mm)
  • Persistent ST-elevation (> 50%) following reperfusion
  • Index of microvascular resistance (IMR) > 40

Exclusion Criteria:

  • Absence of normal coronary flow (TIMI 3)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01851291

Locations
United Kingdom
Golden Jubilee National Hospital
Clydebank, Glasgow, United Kingdom, G81 4DY
Sponsors and Collaborators
Prof. Keith G. Oldroyd
British Heart Foundation
Investigators
Principal Investigator: Colin Berry, BSc PhD FRCP FACC Golden Jubilee National Hospital
  More Information

No publications provided

Responsible Party: Prof. Keith G. Oldroyd, Professor Keith Oldroyd, NHS National Waiting Times Centre Board
ClinicalTrials.gov Identifier: NCT01851291     History of Changes
Other Study ID Numbers: Defer-practice-PG-11-2-28474
Study First Received: May 5, 2013
Last Updated: May 9, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by NHS National Waiting Times Centre Board:
STEMI
No-reflow
Primary percutaneous intervention
Deferred stenting

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014