ClinicalTrials.gg
Sign In
CompletedNCT00507156POSTCONUpdated Oct 6, 2016

Postconditioning in the Treatment of Acute ST-segment Elevation Myocardial Infarction

A Phase 4 interventional study of Standard primary PCI and Mechanical postconditioning in ST-segment Myocardial Infarction, sponsored by Copenhagen University Hospital, Rigshospitalet. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-06.

Sponsored by Copenhagen University Hospital, Rigshospitalet · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Standard treatment of patients with acute ST-segment elevation myocardial infarction consist of acute re-opening of the occluded coronary artery (primary PCI). Despite successful treatment of the epicardial vessel reperfusion is sometimes inadequate leading to large final infarct sizes. This phenomenon is known as the reperfusion injury. Several animal studies have indicated that graded re-opening of the artery may limit tissue damage. Generally this is referred to as mechanical postconditioning.

The study investigates the effect on final infarct size evaluated by magnetic resonance scan of postconditioning of ST-segment elevation myocardial infarctions. Mechanical postconditioning is performed by means of several balloon inflations in the injured vessel following its acute re-opening.

Read the detailed description

Please see above

02

Conditions studied

  • ST-segment Myocardial Infarction
03

In context

Lead sponsor

Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 39 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients more than 18 years
  • STEMI \< 12 hours
  • TIMI 0-1 in infarct related artery

Exclusion criteria

Exclusion Criteria:

  • Multivessel disease (stenoses in non-infarct related arteries >70%)
  • Cardiogenic shock
  • Left main occlusions
  • Lesions that cannot be treated with stents
  • Previous CABG
  • Pregnancy
  • Severe renal insufficiency
  • Previous extensive Q-wave infarction
  • LBBB
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Mek postcon

    Re-opening of the infarcted coronary artery by several balloon inflations separated by reperfusion of the vessel.

    Procedure: Mechanical postconditioning

  • Active comparator
    Standard treatment

    Standard treatment (primary PCI)

    Procedure: Standard primary PCI

Interventions

  • ProcedureStandard primary PCI

    Acute re-opening of the occluded coronary artery

  • ProcedureMechanical postconditioning

    Mechanical postconditioning with 4 cycles 30/30 sek balloon inflations

06

What researchers measure

Primary outcomes

  1. Final infarct size evaluated by MR

    Time frame: 3 month

Secondary outcomes

  1. MACE (death, re-infarction, TLR)

    Time frame: 1, 15 month

  2. Stent thrombosis

    Time frame: 15 month

07

Study locations

1 site
  • Cardiac Catherization Lab., Heart Center, Rigshospitalet, University of Copenhagen
    Copenhagen, 2100, Denmark
08

References and documents

Publications

  • Lonborg J, Holmvang L, Kelbaek H, Vejlstrup N, Jorgensen E, Helqvist S, Saunamaki K, Clemmensen P, Treiman M, Jensen JS, Engstrom T. ST-Segment resolution and clinical outcome with ischemic postconditioning and comparison to magnetic resonance. Am Heart J. 2010 Dec;160(6):1085-91. doi: 10.1016/j.ahj.2010.09.026. PubMed 21146662 ↗
  • Lonborg J, Kelbaek H, Vejlstrup N, Jorgensen E, Helqvist S, Saunamaki K, Clemmensen P, Holmvang L, Treiman M, Jensen JS, Engstrom T. Cardioprotective effects of ischemic postconditioning in patients treated with primary percutaneous coronary intervention, evaluated by magnetic resonance. Circ Cardiovasc Interv. 2010 Feb 1;3(1):34-41. doi: 10.1161/CIRCINTERVENTIONS.109.905521. Epub 2010 Jan 26. PubMed 20118154 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2007 and a primary completion of Nov 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2007
First posted
Jul 25, 2007
Start
Jul 2007
Primary completionActual
Nov 2008
Last update
Oct 6, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00507156
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
Responsible party
Thomas Engstrom (Chief Consultant, Copenhagen University Hospital, Rigshospitalet) — Principal investigator
First posted
Jul 25, 2007
Start date
Jul 2007
Primary completion
Nov 2008
Last update
Oct 6, 2016

Study contacts

Thomas Engstrom, D.Sci., PhD
study chair · Cheif Consultant
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Copenhagen University Hospital, Rigshospitalet

Start the discussion