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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014