Acute Myocardial InfarctionSINERGY-ACUTENCT04506047
Acute and Long-term Outcomes of Patients With Acute Myocardial Infarction Treated With PCI
An observational study of Acute Myocardial Infarction and Coronary Artery Disease, run by Clinical Centre of Serbia at 1 site in Serbia.
Trial summary
Randomized studies may often be burdened by the selective nature of patient inclusion thus not reflecting real-world outcomes. This is evident from the discrepancy in the mortality rates reported in major randomized trials enrolling patients with acute myocardial infarction (AMI), as compared with registry data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Coronary Artery Disease
- What is being tested?
- Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- How many people
- 30,000 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Jan 2009to Jan 2025
- How long will I take part?
- 5 Years
- 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: This registry is based on consecutive patients with the initial diagnosis of acute myocardial infarction on admission to hospital, who are referred to invasive treatment, i.e. invasive coronary angiography with an intention to perform percutaneous coronary intervention. The study population will include both retrospective, multi-center registry data starting with the year 2009, and the prospectively enrolled patients according to the same pre-specified, broad inclusion/exclusion criteria. The underlying intention is to short- and long-term outcomes of a large population of unselected, real-world patients presenting with AMI and treated with PCI.
Who may be able to join
- Patients with acute myocardial infarction referred to catheterization laboratory for percutaneous coronary intervention
Who cannot join
- Initial acute myocardial infarction diagnosis not confirmed
- Patients with acute myocardial infarction not undergoing invasive coronary angiography
Trial locations and contacts
1 site in 1 country.
Serbia1 site, 1 recruiting
- Recruiting
Clinical Centre of Serbia, Department of Cardiology
Belgrade, 11000
Goran Stankovic, MD, PhD
About this study
Official title: Acute and Long-term Outcomes of Patients Presenting With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention
Randomized studies may often be burdened by the selective nature of patient inclusion thus not reflecting real-world outcomes. This is evident from the discrepancy in the mortality rates reported in major randomized trials enrolling patients with acute myocardial infarction (AMI), as compared with registry data.
The primary objective of this observational study is to assess short- and long-term outcomes of unselected, real-world patients presenting with AMI and treated with contemporary percutaneous coronary intervention (PCI).
- Being tested
- Percutaneous Coronary Intervention
- Keywords
- AMI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionProcedure or surgery
Percutaneous Coronary Intervention
| Study group | Role | What they receive |
|---|---|---|
| Acute Myocardial Infarction | Consecutive patients with acute myocardial infarction Receives: Procedure: Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of all-cause mortality
Rate of all-cause mortality at 1 year
Measured: 1 year
Secondary outcomes (2)
Rate of all-cause mortality
Rate of all-cause mortality at 5 years
Measured: 5 years
Rate of cardiovascular mortality
Rate of cardiovascular mortality at 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Jan 2009
- Primary completionJan 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies 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
- Other
- Enrolment
- 30,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Clinical Centre of Serbia
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Cardiovascular Diseases, Vojvodina, Clinical Hopital Center Zemun, University Hospital Medical Center Bezanijska Kosa, Clinical Center Kragujevac, Clinical Hospital Center Zvezdara
- Responsible party
- Principal investigator, Goran Stankovic, Clinical Centre of Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506047
- Sponsor's protocol ID
- 570/11
- Acronym
- SINERGY-ACUTE
- Status last verified
- Mar 2022
- First submitted
- 6 Aug 2020
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Long-term Outcomes of Patients Presenting With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04506047
- Acronym / sponsor ID
- SINERGY-ACUTE / 570/11
- Keywords
- AMI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Clinical Centre of SerbiaUniversity, hospital or other
- Collaborators
- Institute of Cardiovascular Diseases, Vojvodina, Clinical Hopital Center Zemun, University Hospital Medical Center Bezanijska Kosa, Clinical Center Kragujevac, Clinical Hospital Center Zvezdara
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 10 Aug 2020 (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.
Randomized studies may often be burdened by the selective nature of patient inclusion thus not reflecting real-world outcomes. This is evident from the discrepancy in the mortality rates reported in major randomized trials enrolling patients with acute myocardial infarction (AMI), as compared with registry data.
The primary objective of this observational study is to assess short- and long-term outcomes of unselected, real-world patients presenting with AMI and treated with contemporary percutaneous coronary intervention (PCI).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Myocardial Infarction | – | Procedure: Percutaneous Coronary InterventionConsecutive patients with acute myocardial infarction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This registry is based on consecutive patients with the initial diagnosis of acute myocardial infarction on admission to hospital, who are referred to invasive treatment, i.e. invasive coronary angiography with an intention to perform percutaneous coronary intervention. The study population will include both retrospective, multi-center registry data starting with the year 2009, and the prospectively enrolled patients according to the same pre-specified, broad inclusion/exclusion criteria. The underlying intention is to short- and long-term outcomes of a large population of unselected, real-world patients presenting with AMI and treated with PCI.
Key inclusion criteria (1 listed)
- Patients with acute myocardial infarction referred to catheterization laboratory for percutaneous coronary intervention
Key exclusion criteria (2 listed)
- Initial acute myocardial infarction diagnosis not confirmed
- Patients with acute myocardial infarction not undergoing invasive coronary angiography
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 |
|---|---|---|
| Percutaneous Coronary InterventionPercutaneous Coronary Intervention | Procedure or surgery | Acute Myocardial Infarction |
Primary outcome
Rate of all-cause mortality
Time frame: 1 year
Rate of all-cause mortality at 1 year
2 secondary outcomes
Rate of all-cause mortality
Time frame: 5 years
Rate of cardiovascular mortality
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Coronary Artery Disease, run by Clinical Centre of Serbia at 1 site in Serbia.
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 2 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: status not confirmed, as of the sponsor's last update on 29 Mar 2022. 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 Serbia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Goran Stankovic, MD, PhD (+381113613653, gorastan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of all-cause mortality (time frame: 1 year). 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 29 Mar 2022.