ImPress: Impact of Injection Pressure on Myocardial Reperfusion During Primary PCI

Sponsor

University Hospital "Sestre Milosrdnice" (Other)

Overall Status

Completed

CT.gov ID

NCT03445364

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Reperfusion STEMI - ST Elevation Myocardial Infarction	Other: Use of different injection pressure during primary PCI	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Impact of Coronary Dye Injection Pressure on Myocardial Reperfusion During the Primary Percutaneous Coronary Intervention.

Actual Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Sep 30, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Low coronary injection-pressure, 200 psi Patients with STEMI who undergo Primary PCI with the use of low intracoronary dye injection pressure (of 200 psi), by using ACIST automated injector. Patients will recieve bare-metal stents at the courtasy of the interventional cardiologist, only in infarct-related artery. Use of different injection pressure during primary PCI	Other: Use of different injection pressure during primary PCI 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
Active Comparator: High coronary injection-pressure,550 psi Patients with STEMI who undergo Primary PCI with the use of higher intracoronary dye injection pressure (of 500 psi), by using ACIST automated injector. Patients will recieve bare-metal stents at the courtasy of the interventional cardiologist, only in infarct-related artery. Use of different injection pressure during primary PCI	Other: Use of different injection pressure during primary PCI 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

Arm

Intervention/Treatment

Active Comparator: Low coronary injection-pressure, 200 psi

Patients with STEMI who undergo Primary PCI with the use of low intracoronary dye injection pressure (of 200 psi), by using ACIST automated injector. Patients will recieve bare-metal stents at the courtasy of the interventional cardiologist, only in infarct-related artery. Use of different injection pressure during primary PCI

Other: Use of different injection pressure during primary PCI

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

Active Comparator: High coronary injection-pressure,550 psi

Patients with STEMI who undergo Primary PCI with the use of higher intracoronary dye injection pressure (of 500 psi), by using ACIST automated injector. Patients will recieve bare-metal stents at the courtasy of the interventional cardiologist, only in infarct-related artery. Use of different injection pressure during primary PCI

Other: Use of different injection pressure during primary PCI

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

Outcome Measures

Primary Outcome Measures

Myocardial Blush Grade [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]
Myocardial Blush grade 0 to 3 (the highest)

Secondary Outcome Measures

Completeness of resolution of ST segment elevation [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]
ST Segment Elevation in milimeters will be measured