Deferred Stent Trial in STEMI

ST-Elevation Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01717573
• Other study ID #: Defer-PG-11-2-28474
• Status: Completed
• Phase: N/A
• First received: October 23, 2012
• Last updated: June 10, 2017
• Start date: March 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2017
• Source: NHS National Waiting Times Centre Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

During primary PCI, stent deployment and post-dilatation are associated with no-reflow. The mechanisms for no reflow include distal embolization of thrombus, enhanced thrombus formation and vascular spasm. No reflow is associated with risk factors such as prolonged duration of ischaemia, heavy thrombus burden, persistent ST elevation and long stent length. ACTIVE HYPOTHESIS: once normal antegrade flow has been re-established with initial aspiration thrombectomy and/or balloon angioplasty at the beginning of primary PCI, compared with usual care with direct stenting, a strategy of deferred stenting for 4 -16 hours to permit the beneficial effects of normalized coronary blood flow and anti-thrombotic therapies will reduce the incidence of no reflow in at-risk STEMI patients. DESIGN: In consecutive STEMI patients with risk factors for no reflow and who have given informed consent, when normal flow has been established (TIMI 3) by initial aspiration thrombectomy and/or balloon angioplasty, participants will be randomized to deferred stenting or usual care with direct stenting. All patients will receive dual anti-platelet therapy. Patients who are randomized to deferred stenting will receive intravenous glycoprotein IIbIIIa inhibitor and anti-coagulation with low molecular weight heparin. Patients who are screened and not eligible to be randomized will be prospectively entered into a registry. Study assessments for feasibility, safety and efficacy will be prospectively performed. An independent clinical event committee will review all serious adverse events. Study endpoints will be subject to core laboratory analyses. The study is intended to inform the design of a larger multicentre clinical trial.

Other known NCT identifiers

• NCT01851291

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: May 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST-Elevation Myocardial Infarction

Intervention

Procedure:
• Deferred stenting

• Conventional treatment

Locations

Country	Name	City	State
United Kingdom	Golden Jubilee National Hospital	Clydebank	Glasgow

Sponsors (5)

Lead Sponsor	Collaborator
NHS National Waiting Times Centre Board	British Heart Foundation, Chief Scientist Office, Scottish Government, Health Sciences Scotland, University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Carrick D, Oldroyd KG, McEntegart M, Haig C, Petrie MC, Eteiba H, Hood S, Owens C, Watkins S, Layland J, Lindsay M, Peat E, Rae A, Behan M, Sood A, Hillis WS, Mordi I, Mahrous A, Ahmed N, Wilson R, Lasalle L, Généreux P, Ford I, Berry C. A randomized tria — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bleeding	Bleeding events related to vascular access or non-access site bleeding. Bleeding was defined according to the ACUITY criteria: major bleed = intracranial or intraocular bleeding; bleeding at the site of angiography requiring intervention; a hematoma of 5 cm in diameter; a reduction in hemoglobin level of at least 4 g/dL in the absence of overt bleeding or 3 g/dL with a source of bleeding; or transfusion.	Index hospital admission
Other	Contrast nephropathy	Contrast-induced nephropathy was defined as either a greater than 25% increase of serum creatinine or an absolute increase in serum creatinine of 0•5 mg/dL after a radiographic examination using a contrast agent.	Index hospitalization
Primary	Incidence of angiographic no-reflow/ slow-reflow (TIMI flow grade < 3) in the deferred and conventional treatment groups		Asessed during the 1st (both groups) and 2nd procedures (deferred group) (0-16 hours)
Secondary	Extent of late microvascular obstruction (MVO) assessed by cardiac MRI		MRI 2-5 days post randomisation
Secondary	Clinical events (hospitalisation for heart failure, re-infarction, cardiac death)		Assessed at index admission and 6-months
Secondary	Degree of ST-segment resolution on ECG		ECG in cath-lab prior to reperfusion and again 60 mins post-reperfusion
Secondary	TIMI coronary arter flow grade		At the beginning and end of the first procedure (for both groups) and at the beginning and end of the second procedure in the deferred group
Secondary	Culprit vessel dimensions (QCA) and thrombus burden		Initial coronary angiogram (and 2nd angiogram in deferred group)
Secondary	Change in LV ejection fraction		Cardiac MRI 2 days and 6-months post PCI
Secondary	Index of microvascular resistance (IMR)		Assessed following stent deployment (initial procedure for the conventional group and 2nd procedure for the deferred group)
Secondary	Corrected TIMI frame count		At the beginning and end of the first procedure (for both groups) and at the beginning and end of the second procedure in the deferred group
Secondary	Angiographic tissue myocardial blush grade		Angiographic myocardial blush grade at the end of the first procedure (both groups) and at the end of the second procedure in the deferred group
Secondary	Intra-procedural thrombotic events		Asessed during the 1st (both groups) and 2nd procedures (deferred group) (0-16 hours)
Secondary	Degree of adverse remodelling (end-systolic and end-diastolic volume index)		Cardiac MRI at 6-months
Secondary	Final infarct size and myocardial salvage		Assessed from cardiac MRI day 2-5 and cardiac MRI at 6months

External Links

•   British Heart Foundation
•   Cardiology Department, Golden Jubilee National Hospital
•   Institute of Cardiovascular and Medical Sciences, University of Glasgow