search
Back to results

Impact of Injection Pressure on Myocardial Reperfusion During Primary PCI (ImPress)

Primary Purpose

Myocardial Reperfusion, STEMI - ST Elevation Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Use of different injection pressure during primary PCI
Sponsored by
University Hospital "Sestre Milosrdnice"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Reperfusion focused on measuring Primary PCI, Coronary injection pressure, Reperfusion, Resolution of ST elevation, Myocardial Blush Grade

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital "Sestre milosrdnice"

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low coronary injection-pressure, 200 psi

High coronary injection-pressure,550 psi

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 7, 2010
Last Updated
February 19, 2018
Sponsor
University Hospital "Sestre Milosrdnice"
search

1. Study Identification

Unique Protocol Identification Number
NCT03445364
Brief Title
Impact of Injection Pressure on Myocardial Reperfusion During Primary PCI
Acronym
ImPress
Official Title
Impact of Coronary Dye Injection Pressure on Myocardial Reperfusion During the Primary Percutaneous Coronary Intervention.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2010 (Actual)
Primary Completion Date
September 30, 2010 (Actual)
Study Completion Date
December 1, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital "Sestre Milosrdnice"

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Reperfusion, STEMI - ST Elevation Myocardial Infarction
Keywords
Primary PCI, Coronary injection pressure, Reperfusion, Resolution of ST elevation, Myocardial Blush Grade

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low coronary injection-pressure, 200 psi
Arm Type
Active Comparator
Arm Description
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
Arm Title
High coronary injection-pressure,550 psi
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Use of different injection pressure during primary PCI
Intervention Description
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
Primary Outcome Measure Information:
Title
Myocardial Blush Grade
Description
Myocardial Blush grade 0 to 3 (the highest)
Time Frame
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 Outcome Measure Information:
Title
Completeness of resolution of ST segment elevation
Description
ST Segment Elevation in milimeters will be measured
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomislav Krcmar, M.D.
Organizational Affiliation
University Hospital "Sestre Milosrdnice"
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital "Sestre milosrdnice"
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only complete study data of all 100 patients recruited so far, will be shared if needed
Citations:
PubMed Identifier
31463362
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.
Results Reference
derived

Learn more about this trial

Impact of Injection Pressure on Myocardial Reperfusion During Primary PCI

We'll reach out to this number within 24 hrs