Myocardial Infarction
Conditions
Keywords
ST-segment elevation myocardial infarction, Primary angioplasty, stent
Brief summary
The goal of primary PCI is to restore anterograde myocardial flow. Stenting a largely thrombotic lesion may determine distal embolisation of thrombotic material therefore deteriorating myocardial perfusion.
Detailed description
In the setting of largely thrombotic lesions such as those treated in the context of primary PCI, stenting often results in distal micro and macro-embolisation which hampers coronary flow and microvascular recovery. Interestingly in some of these studies comparing BMS versus balloon angioplasty an early hazard associated to the use of stent has been reported. Thus, investigators hypothesize in this protocol that refraining from stenting during the acute phase of ST segment myocardial infarction is safe and associated to improved myocardial recovery as compared to acute stenting.
Interventions
PROCEDUREImmediate stenting
Primary coronary stenting
PROCEDUREDelayed stenting
Coronary stenting 3 to 7 days after having reopened the vessel in the acute phase
Sponsors
Marco Valgimigli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* chest pain for \>30 min with ST-segment elevation of one mm or more in 2 or more contiguous ECG leads or with presumably new left bundle-branch block * admission either within 12 h of symptom onset or between 12 and 24 h with evidence of continuing ischaemia
Exclusion criteria
* the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial blush grade (MBG) equal or greater than 2 | post-procedure | The MBG will be estimated visually by 2 experienced observers, as previously described. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ST segment elevation Resolution | 90 minutes after the procedure | — |
| infarct size | 5 days | Infarct size will be quantified by MRI |
| ST segment elevation resolution | 30 minutes after the procedure | Cumulative ST segment elevation in all leads will be quantified before and after the procedure and expressed as percentage |
| microvascular obstruction | 5 days | microvascular obstruction will be quantified by MRI |
| Mortality | 6 months | overall and cardiac mortality will be assessed up to 6 months |
| Infarct size | 6 months | Infarct size will be quantified by MRI |
Countries
Italy
Contacts
Primary ContactAlessandro Dal Monte, MD
Backup ContactMarco Valgimigli, MD, PhD
Outcome results
None listed