ST-segment Myocardial Infarction
Conditions
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
Interventions
PROCEDUREStandard primary PCI
Acute re-opening of the occluded coronary artery
PROCEDUREMechanical postconditioning
Mechanical postconditioning with 4 cycles 30/30 sek balloon inflations
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Final infarct size evaluated by MR | 3 month |
Secondary
| Measure | Time frame |
|---|---|
| MACE (death, re-infarction, TLR) | 1, 15 month |
| Stent thrombosis | 15 month |
Countries
Denmark
Outcome results
None listed