ST-segment Myocardial InfarctionPhase 4POSTCONNCT00507156
Postconditioning in the Treatment of Acute ST-segment Elevation Myocardial Infarction
A Phase 4 study testing Standard primary PCI and Mechanical postconditioning in people with ST-segment Myocardial Infarction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-segment Myocardial Infarction
- What is being tested?
- Standard primary PCI and Mechanical postconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2007to Nov 2008
- Phase
- Phase 4
- 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
- Patients more than 18 years
- STEMI < 12 hours
- TIMI 0-1 in infarct related artery
Who cannot join
- Multivessel disease (stenoses in non-infarct related arteries >70%)
- Cardiogenic shock
- Left main occlusions
- Lesions that cannot be treated with stents
- Previous CABG
- Pregnancy
Show all 9Show fewer
- Severe renal insufficiency
- Previous extensive Q-wave infarction
- LBBB
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Cardiac Catherization Lab., Heart Center, Rigshospitalet, University of Copenhagen
Copenhagen, 2100
About this study
Official title: Postconditioning Used to Limit Final Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction
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
- Conditions
- ST-segment Myocardial Infarction
- Being tested
- Standard primary PCI, Mechanical postconditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard primary PCIProcedure or surgery
Acute re-opening of the occluded coronary artery
Mechanical postconditioningProcedure or surgery
Mechanical postconditioning with 4 cycles 30/30 sek balloon inflations
| Study group | Role | What they receive |
|---|---|---|
| Mek postcon | Experimental | Re-opening of the infarcted coronary artery by several balloon inflations separated by reperfusion of the vessel. Receives: Procedure: Mechanical postconditioning |
| Standard treatment | Active comparator | Standard treatment (primary PCI) Receives: Procedure: Standard primary PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final infarct size evaluated by MR
Measured: 3 month
Secondary outcomes (2)
MACE (death, re-infarction, TLR)
Measured: 1, 15 month
Stent thrombosis
Measured: 15 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ST-segment Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Engstrom, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Thomas Engstrom, D.Sci., PhD, Study chair, Cheif Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507156
- Sponsor's protocol ID
- KF 01 326257
- Acronym
- POSTCON
- Status last verified
- Oct 2016
- First submitted
- 23 Jul 2007
- Last updated
- 6 Oct 2016
- Results posted
- No
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 21146662Lonborg 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postconditioning Used to Limit Final Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00507156
- Acronym / sponsor ID
- POSTCON / KF 01 326257
- Conditions
- ST-segment Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Nov 2008 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Please see above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mek postcon | Experimental | Procedure: Mechanical postconditioningRe-opening of the infarcted coronary artery by several balloon inflations separated by reperfusion of the vessel. |
| Standard treatment | Active comparator | Procedure: Standard primary PCIStandard treatment (primary PCI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients more than 18 years
- STEMI < 12 hours
- TIMI 0-1 in infarct related artery
Key exclusion criteria (9 listed)
- Multivessel disease (stenoses in non-infarct related arteries >70%)
- Cardiogenic shock
- Left main occlusions
- Lesions that cannot be treated with stents
- Previous CABG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard primary PCIAcute re-opening of the occluded coronary artery | Procedure or surgery | Standard treatment |
| Mechanical postconditioningMechanical postconditioning with 4 cycles 30/30 sek balloon inflations | Procedure or surgery | Mek postcon |
Primary outcome
Final infarct size evaluated by MR
Time frame: 3 month
2 secondary outcomes
MACE (death, re-infarction, TLR)
Time frame: 1, 15 month
Stent thrombosis
Time frame: 15 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Derived from this study: PubMed 21146662Lonborg 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.
- Derived from this study: PubMed 20118154Lonborg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Engstrom, D.Sci., PhD study chair
Cheif Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard primary PCI and Mechanical postconditioning in people with ST-segment Myocardial Infarction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 9 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 6 Oct 2016. 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 Denmark. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Final infarct size evaluated by MR (time frame: 3 month). 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 NCT00507156, 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 6 Oct 2016.