STEMI - ST Elevation Myocardial Infarction
Conditions
Keywords
Myocardial Reperfusion, Unfractionated heparin, pre-treatment
Brief summary
Rupture of a coronary artery plaque leads to thrombotic occlusion of the coronary artery and would present as ST segment elevation myocardial infarction. Early treatment with aspirin and early primary percutaneous coronary intervention are indicated. Anticoagulation therapy, usually with unfractionated heparin, is required during percutaneous coronary intervention. Investigators hypothesis is that pretreatment with unfractionated heparin in addition to aspirin at first medical contact may facilitate spontaneous reperfusion of culprit artery and procedural thrombotic complication in patients with ST elevation myocardial infarction without significant risk of bleeding complications.
Detailed description
Randomization of patients with STEMI at first medical contact in a 1:1 ratio into an intervention group receiving 100 IU of unfractionated heparin (UFH) per kilogram of body weight IV and later additionally UFH after diagnostic coronary angiography according to the activated clotting time (ACT) and a control group receiving only UFH after diagnostic coronary angiography at the dose of 100 IU per kilogram of body weight. The primary end point of the study is TIMI flow at coronary angiography. Secondary endpoints are: Bleeding complications (defined by BARC score), occurrence of cardiogenic shock, and 30-day mortality. Investigators plan to randomize 600 patients.
Interventions
DRUGUnfractionated heparin
Unfractionated heparin at dose of 100 IU /kg body weight
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Interventional cardiologists evaluating coronary angiography will be blinded to assigned group
Intervention model description
randomization in 1:1 ratio
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with STEMI referred for primary PCI * Duration of symptoms less than 6 hours before presentation
Exclusion criteria
* Pregnancy * Cardiogenic shock at presentation (hemodynamic instability) * Cardiac arrest before randomization * Duration of symptoms for more than 6 hours before presentation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TIMI flow | Day 0 | TIMI flow in culprit coronary artery at first coronary angiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding | Day 0 | Bleeding assessed by Bleeding Academic Research Consortium (BARC) score. BARC incorporates 5 bleeding types, ranging from BARC 0 - no bleeding to BARC 5 - fatal bleeding. |
| Cardiogenic shock | Day 0 to 10 | Presence of cardiogenic shock at any time after randomization |
| 30 day mortality after STEMI | 30 days | 30-day mortality after STEMI |
| Troponin I concentration 24 h after primary PCI | 24 h | Troponin I concentration 24 h after primary PCI |
Countries
Slovenia
Outcome results
None listed