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ST-Elevation Myocardial InfarctionNCT01717573

Deferred Stent Trial in STEMI

A study testing Deferred stenting and Conventional treatment in people with ST-Elevation Myocardial Infarction, run by NHS National Waiting Times Centre Board at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ST-Elevation Myocardial Infarction
What is being tested?
Deferred stenting and Conventional treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
101 participants
Where
1 siteUnited Kingdom
Study dates
Mar 2012to May 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Rescue PCI
  • Prolonged ischaemic time (> 12hours)
  • Previous MI
  • Age > 65
  • Occluded artery (TIMI 0/1) at initial angiography
  • Thrombus burden (TIMI grade 2+)
Show all 11Show fewer
  • 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

Who cannot join

  • Absence of normal coronary flow (TIMI 3)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Golden Jubilee National Hospital

    Clydebank, Glasgow, G81 4DY

Other trials in United Kingdom

About this study

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

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.

Being tested
Deferred stenting, Conventional treatment
Keywords
STEMI, No-reflow, Primary percutaneous intervention, Deferred stenting
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deferred stentingProcedure or surgery

  • Conventional treatmentProcedure or surgery

Study groups in NCT01717573
Study groupRoleWhat they receive
Deferred stentingActive comparatorDuring primary PCI in STEMI, when TIMI 3 flow has been re-established with guide-wire, aspiration thrombectomy and/or balloon angioplasty, stenting is then deferred for a period of 4-16 hours following reperfusion. During this time, patients remain in the Coronary Care Unit and will receive intravenous tirofiban and subcutaneous low molecular weight heparin (enoxaparin 1 mg/kg)
Receives: Procedure: Deferred stenting
Conventional treatmentSham comparatorConventional treatment in STEMI, with immediate stenting
Receives: Procedure: Conventional treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of angiographic no-reflow/ slow-reflow (TIMI flow grade < 3) in the deferred and conventional treatment groups

    Measured: Asessed during the 1st (both groups) and 2nd procedures (deferred group) (0-16 hours)

Secondary outcomes (12)

  1. Extent of late microvascular obstruction (MVO) assessed by cardiac MRI

    Measured: MRI 2-5 days post randomisation

  2. Clinical events (hospitalisation for heart failure, re-infarction, cardiac death)

    Measured: Assessed at index admission and 6-months

  3. Degree of ST-segment resolution on ECG

    Measured: ECG in cath-lab prior to reperfusion and again 60 mins post-reperfusion

  4. TIMI coronary arter flow grade

    Measured: 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

  5. Culprit vessel dimensions (QCA) and thrombus burden

    Measured: Initial coronary angiogram (and 2nd angiogram in deferred group)

  6. Change in LV ejection fraction

    Measured: Cardiac MRI 2 days and 6-months post PCI

  7. Index of microvascular resistance (IMR)

    Measured: Assessed following stent deployment (initial procedure for the conventional group and 2nd procedure for the deferred group)

  8. Corrected TIMI frame count

    Measured: 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

  9. Angiographic tissue myocardial blush grade

    Measured: 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

  10. Intra-procedural thrombotic events

    Measured: Asessed during the 1st (both groups) and 2nd procedures (deferred group) (0-16 hours)

  11. Degree of adverse remodelling (end-systolic and end-diastolic volume index)

    Measured: Cardiac MRI at 6-months

  12. Final infarct size and myocardial salvage

    Measured: Assessed from cardiac MRI day 2-5 and cardiac MRI at 6months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionNov 2012
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01717573
Sponsor's protocol ID
Defer-PG-11-2-28474
Status last verified
Oct 2024
First submitted
23 Oct 2012
Last updated
29 Oct 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • 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, Genereux P, Ford I, Berry C. A randomized trial of deferred stenting versus immediate stenting to prevent no- or slow-reflow in acute ST-segment elevation myocardial infarction (DEFER-STEMI). J Am Coll Cardiol. 2014 May 27;63(20):2088-2098. doi: 10.1016/j.jacc.2014.02.530. Epub 2014 Feb 27.

    PubMed 24583294

  • Gao H, Aderhold A, Mangion K, Luo X, Husmeier D, Berry C. Changes and classification in myocardial contractile function in the left ventricle following acute myocardial infarction. J R Soc Interface. 2017 Jul;14(132):20170203. doi: 10.1098/rsif.2017.0203.

    PubMed 28747397

Questions about this trial

What is this clinical trial studying?

A study testing Deferred stenting and Conventional treatment in people with ST-Elevation Myocardial Infarction, run by NHS National Waiting Times Centre Board at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of angiographic no-reflow/ slow-reflow (TIMI flow grade < 3) in the deferred and conventional treatment groups (time frame: Asessed during the 1st (both groups) and 2nd procedures (deferred group) (0-16 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01717573, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.

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