Acute Myocardial Infarction (AMI)NCT07086807
Predictors and Impact of Total Occlusion of the Infarct-Related Coronary Artery on Short-Term Outcomes
An observational study of Acute Myocardial Infarction (AMI), run by University Hospital Sestre Milosrdnice.
Trial summary
Aim of this study is to determine the prevalence, predictors, and impact of total occlusion of the infarct-related coronary artery (IRA) on short-term mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction (AMI)
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 Dec 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with PCI for AMI at the University Hospital Centre Sestre milosrdnice, Zagreb, Croatia between 2011 and 2018.
Who may be able to join
- patients treated with PCI for AMI
Who cannot join
- treated without PCI,
- diagnosed with myocardial infarction with non-obstructive coronary arteries (MINOCA),
- underwent surgical revascularization (coronary artery bypass grafting).
About this study
Official title: Predictors and Impact of Total Occlusion of the Infarct-Related Coronary Artery on Short-Term Mortality in Patients With Acute Myocardial Infarction
Aim of this study is to determine the prevalence, predictors, and impact of total occlusion of the infarct-related coronary artery (IRA) on short-term mortality.
Read the detailed description
We will conduct a prospective, single-center cohort study based on a clinical registry that will include consecutive patients treated for acute myocardial infarction (AMI) with percutaneous coronary intervention (PCI) at the University Hospital Centre Sestre milosrdnice, Zagreb, Croatia, between 2011 and 2018. All patients will receive treatment in accordance with the European Society of Cardiology (ESC) guidelines current at the time. Revascularization will be performed by five experienced interventional cardiologists, each with over five years of experience and performing more than 150 PCI procedures annually. The identification of the culprit lesion will be left to the discretion of the operating physician.
Patients will be excluded if they are treated without PCI, are diagnosed with myocardial infarction with non-obstructive coronary arteries (MINOCA), or undergo surgical revascularization (coronary artery bypass grafting).
Data will be collected from the hospital electronic medical records and patient charts. Mortality data will be obtained from the Croatian National Institute of Public Health cause-of-death registry. Collected variables will include baseline demographic data, medical history, chronic pre-admission pharmacotherapy, in-hospital course, complications, and procedural characteristics. All angiograms will be re-evaluated independently by two experienced interventional cardiologists. Chronic pharmacotherapy will be considered relevant if the patient has been taking the medication for at least four weeks prior to the index event. Significant carotid artery stenosis will be defined as a luminal narrowing of more than 50%.
Patients will be divided into two groups based on the patency of the infarct-related artery (IRA): those with an occluded coronary artery (OCA group) and those with a patent coronary artery (PCA group). A patent artery will be defined as having visible antegrade flow of at least TIMI grade I distal to the culprit lesion. Occlusion will be defined as complete absence of antegrade flow beyond the site of the lesion (TIMI 0), with no visible antegrade or retrograde collateral circulation. All the patients will be pretreated with 300 mg of acetylsalicylic acid and 600 mg of clopidogrel or 180 mg of ticagrelor, depending on current guidelines.
All patients will be followed until the primary endpoint is reached or for 30 days from the index hospitalization. The primary clinical endpoint will be all-cause mortality during the follow-up period.
Statistical analysis will be performed using appropriate methods depending on data distribution. Continuous variables will be expressed as medians with interquartile ranges or as means with standard deviations, as appropriate. Normality of distribution will be assessed using the Shapiro-Wilk test. To assess statistical significance between groups, the Mann-Whitney test will be used for continuous variables, and the χ² test for discrete variables. A two-sided p-value of <0.05 will be considered statistically significant. Due to multiple comparisons, adjustment by the Benjamini-Hochberg method will be applied.
Evaluation of survival over the 30-day follow-up period will be performed using Kaplan-Meier survival curves, and the log-rank test will be used to compare survival rates between groups. Cox proportional hazards regression analysis will be used to identify independent predictors of 30-day mortality. To assess independent predictors of an occlusive type of myocardial infarction, logistic regression analysis will be employed. The statistical analysis will be performed using SPSS Version 20 (IBM SPSS Statistics, New York, USA).
- Conditions
- Acute Myocardial Infarction (AMI)
- Keywords
- myocardial infarcion, infarct related artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with occluded IRA | Patients with acute occlusion (TIMI 0) of the infarct-related artery (IRA) at the time of the coronary intervention due to acute myocardial infartion | |
| Patients with patent IRA | Patients with acute non-occlusion (TIMI 1-3) of the infarct-related artery (IRA) at the time of the coronary intervention due to acute myocardial infartion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death due to all reasons in a period od 12 months after myocardial infartion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Jan 2011
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Sestre Milosrdnice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikola Kos, University Hospital Sestre Milosrdnice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086807
- Sponsor's protocol ID
- KBSestreMil
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors and Impact of Total Occlusion of the Infarct-Related Coronary Artery on Short-Term Mortality in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07086807
- Acronym / sponsor ID
- KBSestreMil
- Conditions
- Acute Myocardial Infarction (AMI)
- Keywords
- myocardial infarcion, infarct related artery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University Hospital Sestre MilosrdniceUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 25 Jul 2025 (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.
Aim of this study is to determine the prevalence, predictors, and impact of total occlusion of the infarct-related coronary artery (IRA) on short-term mortality.
Detailed description
We will conduct a prospective, single-center cohort study based on a clinical registry that will include consecutive patients treated for acute myocardial infarction (AMI) with percutaneous coronary intervention (PCI) at the University Hospital Centre Sestre milosrdnice, Zagreb, Croatia, between 2011 and 2018. All patients will receive treatment in accordance with the European Society of Cardiology (ESC) guidelines current at the time. Revascularization will be performed by five experienced interventional cardiologists, each with over five years of experience and performing more than 150 PCI procedures annually. The identification of the culprit lesion will be left to the discretion of the operating physician.
Patients will be excluded if they are treated without PCI, are diagnosed with myocardial infarction with non-obstructive coronary arteries (MINOCA), or undergo surgical revascularization (coronary artery bypass grafting).
Data will be collected from the hospital electronic medical records and patient charts. Mortality data will be obtained from the Croatian National Institute of Public Health cause-of-death registry. Collected variables will include baseline demographic data, medical history, chronic pre-admission pharmacotherapy, in-hospital course, complications, and procedural characteristics. All angiograms will be re-evaluated independently by two experienced interventional cardiologists. Chronic pharmacotherapy will be considered relevant if the patient has been taking the medication for at least four weeks prior to the index event. Significant carotid artery stenosis will be defined as a luminal narrowing of more than 50%.
Patients will be divided into two groups based on the patency of the infarct-related artery (IRA): those with an occluded coronary artery (OCA group) and those with a patent coronary artery (PCA group). A patent artery will be defined as having visible antegrade flow of at least TIMI grade I distal to the culprit lesion. Occlusion will be defined as complete absence of antegrade flow beyond the site of the lesion (TIMI 0), with no visible antegrade or retrograde collateral circulation. All the patients will be pretreated with 300 mg of acetylsalicylic acid and 600 mg of clopidogrel or 180 mg of ticagrelor, depending on current guidelines.
All patients will be followed until the primary endpoint is reached or for 30 days from the index hospitalization. The primary clinical endpoint will be all-cause mortality during the follow-up period.
Statistical analysis will be performed using appropriate methods depending on data distribution. Continuous variables will be expressed as medians with interquartile ranges or as means with standard deviations, as appropriate. Normality of distribution will be assessed using the Shapiro-Wilk test. To assess statistical significance between groups, the Mann-Whitney test will be used for continuous variables, and the χ² test for discrete variables. A two-sided p-value of <0.05 will be considered statistically significant. Due to multiple comparisons, adjustment by the Benjamini-Hochberg method will be applied.
Evaluation of survival over the 30-day follow-up period will be performed using Kaplan-Meier survival curves, and the log-rank test will be used to compare survival rates between groups. Cox proportional hazards regression analysis will be used to identify independent predictors of 30-day mortality. To assess independent predictors of an occlusive type of myocardial infarction, logistic regression analysis will be employed. The statistical analysis will be performed using SPSS Version 20 (IBM SPSS Statistics, New York, USA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with occluded IRA | – | –Patients with acute occlusion (TIMI 0) of the infarct-related artery (IRA) at the time of the coronary intervention due to acute myocardial infartion |
| Patients with patent IRA | – | –Patients with acute non-occlusion (TIMI 1-3) of the infarct-related artery (IRA) at the time of the coronary intervention due to acute myocardial infartion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with PCI for AMI at the University Hospital Centre Sestre milosrdnice, Zagreb, Croatia between 2011 and 2018.
Key inclusion criteria (1 listed)
- patients treated with PCI for AMI
Key exclusion criteria (3 listed)
- treated without PCI,
- diagnosed with myocardial infarction with non-obstructive coronary arteries (MINOCA),
- underwent surgical revascularization (coronary artery bypass grafting).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 12 months
Death due to all reasons in a period od 12 months after myocardial infartion
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 25 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction (AMI), run by University Hospital Sestre Milosrdnice.
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 1 inclusion and 3 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 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Mortality (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2025.