Back to resultsPostconditioning in the Treatment of Acute ST-segment Elevation Myocardial Infarction (POSTCON)
Primary Purpose
ST-segment Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Standard primary PCI
Mechanical postconditioning
Sponsored by
About this trial
This is an interventional treatment trial for ST-segment Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
- Patients more than 18 years
- STEMI < 12 hours
- TIMI 0-1 in infarct related artery
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
Sites / Locations
- Cardiac Catherization Lab., Heart Center, Rigshospitalet, University of Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mek postcon
Standard treatment
Arm Description
Re-opening of the infarcted coronary artery by several balloon inflations separated by reperfusion of the vessel.
Standard treatment (primary PCI)
Outcomes
Primary Outcome Measures
Final infarct size evaluated by MR
Secondary Outcome Measures
MACE (death, re-infarction, TLR)
Stent thrombosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00507156
Brief Title
Postconditioning in the Treatment of Acute ST-segment Elevation Myocardial Infarction
Acronym
POSTCON
Official Title
Postconditioning Used to Limit Final Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
5. Study Description
Brief 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.
Detailed Description
Please see above
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-segment Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mek postcon
Arm Type
Experimental
Arm Description
Re-opening of the infarcted coronary artery by several balloon inflations separated by reperfusion of the vessel.
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
Standard treatment (primary PCI)
Intervention Type
Procedure
Intervention Name(s)
Standard primary PCI
Intervention Description
Acute re-opening of the occluded coronary artery
Intervention Type
Procedure
Intervention Name(s)
Mechanical postconditioning
Intervention Description
Mechanical postconditioning with 4 cycles 30/30 sek balloon inflations
Primary Outcome Measure Information:
Title
Final infarct size evaluated by MR
Time Frame
3 month
Secondary Outcome Measure Information:
Title
MACE (death, re-infarction, TLR)
Time Frame
1, 15 month
Title
Stent thrombosis
Time Frame
15 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients more than 18 years
STEMI < 12 hours
TIMI 0-1 in infarct related artery
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Engstrom, D.Sci., PhD
Organizational Affiliation
Cheif Consultant
Official's Role
Study Chair
Facility Information:
Facility Name
Cardiac Catherization Lab., Heart Center, Rigshospitalet, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
21146662
Citation
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.
Results Reference
derived
PubMed Identifier
20118154
Citation
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.
Results Reference
derived
Learn more about this trial
Postconditioning in the Treatment of Acute ST-segment Elevation Myocardial Infarction
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