Impact of Injection Pressure on Myocardial Reperfusion During Primary PCI

NCT03445364 | Completed

• 1 other identifier: cp0001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Reperfusion; STEMI - ST Elevation Myocardial Infarction

Keywords

Primary PCI; Coronary injection pressure; Reperfusion; Resolution of ST elevation; Myocardial Blush Grade

Outcome Measures

Primary Outcomes (1)

• Myocardial Blush Grade

  Myocardial Blush grade 0 to 3 (the highest)

  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 (1)

• 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

Study Arms (2)

Low coronary injection-pressure, 200 psi

ACTIVE COMPARATOR

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

High coronary injection-pressure,550 psi

ACTIVE COMPARATOR

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

Interventions

Use of different injection pressure during primary PCI OTHER

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

High coronary injection-pressure,550 psi; Low coronary injection-pressure, 200 psi

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Sestre Milosrdnice: lead

Study Sites (1)

University Hospital "Sestre milosrdnice"

Zagreb, 10000, Croatia

Location

Related Publications (1)

• 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.

  PMID: 31463362 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Tomislav Krcmar, M.D.

  University Hospital Sestre Milosrdnice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D., Assisst. Prof.

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: February 26, 2018
• Study Start: April 1, 2010
• Primary Completion: September 30, 2010
• Study Completion: December 1, 2010
• Last Updated: February 26, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)