Clinical trial NCT03445364: Impact of Injection Pressure on Myocardial Reperfusion During Primary PCI
Official title: Impact of Coronary Dye Injection Pressure on Myocardial Reperfusion During the Primary Percutaneous Coronary Intervention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Reperfusion
STEMI - ST Elevation Myocardial Infarction
Keywords: Primary PCI
Coronary injection pressure
Reperfusion
Resolution of ST elevation
Myocardial Blush Grade
Lead sponsor: University Hospital Sestre Milosrdnice
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Acute myocardial infarction with ST elevation
* Less than 12 hours of symptoms beginning
* Clear indication for primary PCI
* No contraindication for primary PCI
* Age 18 to 85

Exclusion Criteria:

* Cardiogenic or any other shock
* More than two culprit lesions/vessels
* Any major complication during PCI
* Unsuccessful intervention

Primary outcomes:
measure: Myocardial Blush Grade
timeFrame: At the day of inclusion in the study; at the begining og the PCI procedure and second measure - 2 minutes before the end of the primary PCI, at the last cine of the infarct related artery and the corresponding myocardium
Secondary outcomes:
measure: Completeness of resolution of ST segment elevation
timeFrame: At the first day of the inclusion in the study; ECG at admission and ECG at 60 to 90 minutes after the primary PCI procedure
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital "Sestre milosrdnice"
Study officials:
affiliation: University Hospital Sestre Milosrdnice
name: Tomislav Krcmar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stambuk K, Krcmar T, Zeljkovic I. Impact of intracoronary contrast injection pressure on reperfusion during primary percutaneous coronary intervention in acute ST-segment elevation myocardial infarction: A prospective randomized pilot study. Int J Cardiol Heart Vasc. 2019 Aug 20;24:100412. doi: 10.1016/j.ijcha.2019.100412. eCollection 2019 Sep.