Myocardial ReperfusionImPressNCT03445364
Impact of Injection Pressure on Myocardial Reperfusion During Primary PCI
A study testing Use of different injection pressure during primary PCI in people with Myocardial Reperfusion and STEMI - ST Elevation Myocardial Infarction, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Reperfusion, STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- Use of different injection pressure during primary PCI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Apr 2010to 1 Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cardiogenic or any other shock
- More than two culprit lesions/vessels
- Any major complication during PCI
- Unsuccessful intervention
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Use of different injection pressure during primary PCI
- Keywords
- Primary PCI, Coronary injection pressure, Reperfusion, Resolution of ST elevation, Myocardial Blush Grade
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of different injection pressure during primary PCIOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Use of different injection pressure during primary PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Blush Grade
Myocardial Blush grade 0 to 3 (the highest)
Measured: 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
ST Segment Elevation in milimeters will be measured
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Apr 2010
- Primary completion30 Sep 2010
- Study completion1 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial ReperfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Sestre Milosrdnice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stambuk Kresimir, University Hospital Sestre Milosrdnice
- Investigators
- Tomislav Krcmar, M.D., Principal investigator, University Hospital Sestre Milosrdnice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445364
- Sponsor's protocol ID
- cp0001
- Acronym
- ImPress
- Status last verified
- Feb 2018
- First submitted
- 7 Jun 2010
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Only complete study data of all 100 patients recruited so far, will be shared if needed
Publications
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.
PubMed 31463362
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Coronary Dye Injection Pressure on Myocardial Reperfusion During the Primary Percutaneous Coronary Intervention.
- ClinicalTrials.gov ID
- NCT03445364
- Acronym / sponsor ID
- ImPress / cp0001
- Keywords
- Primary PCI, Coronary injection pressure, Reperfusion, Resolution of ST elevation, Myocardial Blush Grade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital Sestre MilosrdniceUniversity, hospital or other
- Study start
- 1 Apr 2010 (actual)
- Primary completion
- 30 Sep 2010 (actual)
- Study completion
- 1 Dec 2010 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low coronary injection-pressure, 200 psi | Active comparator | Other: Use of different injection pressure during primary PCIPatients 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 |
| High coronary injection-pressure,550 psi | Active comparator | Other: Use of different injection pressure during primary PCIPatients 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Cardiogenic or any other shock
- More than two culprit lesions/vessels
- Any major complication during PCI
- Unsuccessful intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of different injection pressure during primary PCIUsing 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 | Other | High coronary injection-pressure,550 psi, Low coronary injection-pressure, 200 psi |
Primary outcome
Myocardial Blush Grade
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
Myocardial Blush grade 0 to 3 (the highest)
1 secondary outcome
Completeness of resolution of ST segment elevation
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Derived from this study: PubMed 31463362Stambuk 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.
- Individual participant dataSharing planned: No. Only complete study data of all 100 patients recruited so far, will be shared if needed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomislav Krcmar, M.D. principal investigator
University Hospital Sestre Milosrdnice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of different injection pressure during primary PCI in people with Myocardial Reperfusion and STEMI - ST Elevation Myocardial Infarction, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial Blush Grade (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03445364, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.