Impact of Injection Pressure on Myocardial Reperfusion During Primary PCI
Condition: Myocardial Reperfusion; STEMI - ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Percutaneous coronary intervention for myocardial infarction with ST elevation could be
      complicated with thrombus embolisation to the more distal segments of the culprit artery.
      Hypothesis - lower injection pressure could reduce the incidence of this complication. In
      this study the investigators compare two different protocols for dye injection - first one
      with higher and the second one with lower injection pressure.The impact of different pressure
      will be evaluated using the estimation of completeness of resolution of ST elevation as well
      as Myocardial Blush Grade on the end of the procedure. Patents will be followed for
      in-hospital mortality and MACE.
    

Detailed description: 
      Distal embolization of plaque and thrombotic debris in the infarct-related artery may lead to
      microvascular obstruction resulting in impaired myocardial reperfusion. The aim of the study
      was to assess the impact of contrast injection pressure in coronary arteries, during primary
      percutaneous coronary intervention (PCI), on myocardial reperfusion in patients with acute
      ST-segment elevation myocardial infarction (STEMI).

      A randomized, prospective, open label, pilot study. In the period of 6 months, consecutive
      patients with acute STEMI were included in the study. The acute STEMI was confirmed according
      to the clinical, ECG and cardioselective enzymes criteria.

      Patients with the following features were eligible for inclusion: who underwent primary PCI
      within 12 hours from the onset of symptoms, with typical chest pain lasting >30 minutes, with
      ST-segment elevation of ≥1 mm in ≥2 contiguous leads in ECG and with ECGs recorded at
      admission, 60 minutes and 24h after primary PCI.

      Exclusion criteria were: patients who had cardiogenic shock and/or underwent cardiopulmonary
      resuscitation before or during primary PCI, with symptoms lasting more than 12 hours, with
      left bundle branch block in ECG at admission, with diameter stenosis < 50% of the culprit
      lesion or normal coronary blood flow, with severe left main coronary artery or multivessel
      disease who required emergency cardiac-surgery revascularization, with permanent cardiac
      pacemaker or implantable cardioverter-defibrillator, with anemia (haemoglobin <100 g/L) at
      admission, who underwent cardiothoracic surgery or had a history of moderate or high degree
      valvular pathology, who had life-expectancy of less than 1 year and who did not sign informed
      consent. Patients were admitted through the Emergency Department, where they were evaluated
      for onset and duration of pain, co-morbidities and risk factors. Vital signs and complete
      physical status were recorded. All patients underwent 12-lead ECG and patients with acute
      STEMI were taken immediately to the catheterization laboratory for primary PCI.

      All patients who met the inclusion criteria were randomized into two groups by means of
      sealed envelopes.
    

Intervention name(s): Use of different injection pressure during primary PCI
Intervention type(s): Other
Intervention description(s): Using ACIST injector during the PCI it is possible to change injection pressure - in one arm low pressure of 200psi, and in the second arm average pressure of 550psi
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary PCI; Coronary injection pressure; Reperfusion; Resolution of ST elevation; Myocardial Blush Grade