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

May 5, 2013
May 9, 2013
March 2012
November 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01851291 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Deferred Versus Immediate Stenting in Acute STEMI Conventional Treatment With Immediate Stenting
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
ST-Elevation Myocardial Infarction
  • Procedure: Deferred stenting
  • Procedure: Conventional treatment
    Other Name: Conventional treatment in STEMI, with immediate stenting
  • 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
    Intervention: Procedure: Deferred stenting
  • Sham Comparator: Conventional treatment
    Conventional treatment in STEMI, with immediate stenting
    Intervention: Procedure: Conventional treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
November 2012
November 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01851291
Defer-practice-PG-11-2-28474
Yes
Prof. Keith G. Oldroyd, NHS National Waiting Times Centre Board
Prof. Keith G. Oldroyd
British Heart Foundation
Principal Investigator: Colin Berry, BSc PhD FRCP FACC Golden Jubilee National Hospital
NHS National Waiting Times Centre Board
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP