STEMI - ST Elevation Myocardial Infarction Clinical Trial
Official title:
Impact of Coronary Dye Injection Pressure on Myocardial Reperfusion During the Primary Percutaneous Coronary Intervention.
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.
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.
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