ClinicalTrials.gg
Status unknownNCT04506047SINERGY-ACUTEUpdated Mar 29, 2022

Acute and Long-term Outcomes of Patients With Acute Myocardial Infarction Treated With PCI

An observational study in Acute Myocardial Infarction and Coronary Artery Disease, sponsored by Clinical Centre of Serbia. Status unknown at 1 site in Serbia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-29.

Sponsored by Clinical Centre of Serbia · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
30,000
Ages
18 Years and older
Sex
All
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Study 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.

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).

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Conditions studied

  • Acute Myocardial Infarction
  • Coronary Artery Disease

Keywords

  • AMI
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In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 30,000 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Clinical Centre of Serbia is the lead sponsor of 24 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with acute myocardial infarction referred to catheterization laboratory for percutaneous coronary intervention

Exclusion criteria

Exclusion Criteria:

  • Initial acute myocardial infarction diagnosis not confirmed
  • Patients with acute myocardial infarction not undergoing invasive coronary angiography
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
30,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Acute Myocardial Infarction

    Consecutive patients with acute myocardial infarction

    Procedure: Percutaneous Coronary Intervention

Interventions

  • ProcedurePercutaneous Coronary Intervention

    Percutaneous Coronary Intervention

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What researchers measure

Primary outcomes

  1. Rate of all-cause mortality

    Rate of all-cause mortality at 1 year

    Time frame: 1 year

Secondary outcomes

  1. Rate of all-cause mortality

    Rate of all-cause mortality at 5 years

    Time frame: 5 years

  2. Rate of cardiovascular mortality

    Rate of cardiovascular mortality at 5 years

    Time frame: 5 years

Other outcomes

  1. Rate of myocardial infarction

    Rate of myocardial infarction at 5 years

    Time frame: 5 years

  2. Rate of repeat revascularization

    Rate of repeat revascularization at 5 years

    Time frame: 5 years

  3. Rate of stroke

    Rate of stroke at 5 years

    Time frame: 5 years

  4. Rate of new or worsening heart failure

    Rate of new or worsening heart failure at 5 years

    Time frame: 5 years

  5. Rate of new or worsening heart failure

    Rate of new or worsening heart failure at 1 year

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
  • Clinical Centre of Serbia, Department of Cardiology
    Belgrade, 11000, Serbia
    Recruiting
    • Goran Stankovic, MD, PhD · Contact
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2009 (actual). Primary completion is estimated for Jan 2024, 180 months after the start.

Of 634 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 180 months is above that.

Counting every sponsor, half of 759 studies reached it within 40 months; a quarter within 21 and three quarters within 87.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2020
First posted
Aug 10, 2020
StartActual
Jan 1, 2009
Primary completionEst.
Jan 2024
CompletionEst.
Jan 2025
Last update
Mar 29, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04506047
Lead sponsor
Clinical Centre of Serbia
Collaborators
Institute of Cardiovascular Diseases, Vojvodina, Clinical Hopital Center Zemun, University Hospital Medical Center Bezanijska Kosa, Clinical Centre of Kragujevac, Clinical Hospital Center Zvezdara
Responsible party
Goran Stankovic (Professor, Clinical Centre of Serbia) — Principal investigator
First posted
Aug 10, 2020
Start date
Jan 1, 2009
Primary completion
Jan 2024 (estimated)
Completion
Jan 2025 (estimated)
Last update
Mar 29, 2022

Study contacts

Goran Stankovic, MD, PhD
Contact
gorastan@gmail.com
+381113613653

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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