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

Coronary Artery Disease Clinical Trial

— SINERGY-ACUTE  

Official title:

Acute and Long-term Outcomes of Patients Presenting With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04506047
• Other study ID #: 570/11
• Status: Recruiting
• Start date: January 1, 2009
• Est. completion date: January 2025

Study information

• Verified date: March 2022
• Source: Clinical Centre of Serbia
• Contact: Goran Stankovic, MD, PhD
• Phone: +381113613653
• Email: gorastan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: January 2025
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Initial acute myocardial infarction diagnosis not confirmed

• Patients with acute myocardial infarction not undergoing invasive coronary angiography

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Coronary Artery Disease
• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Percutaneous Coronary Intervention
Percutaneous Coronary Intervention

Locations

Country	Name	City	State
Serbia	Clinical Centre of Serbia, Department of Cardiology	Belgrade

Sponsors (6)

Lead Sponsor	Collaborator
Clinical Centre of Serbia	Clinical Centre of Kragujevac, Clinical Hopital Center Zemun, Clinical Hospital Center Zvezdara, Institute of Cardiovascular Diseases Vojvodina, University Hospital Medical Center Bezanijska Kosa

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of myocardial infarction	Rate of myocardial infarction at 5 years	5 years
Other	Rate of repeat revascularization	Rate of repeat revascularization at 5 years	5 years
Other	Rate of stroke	Rate of stroke at 5 years	5 years
Other	Rate of new or worsening heart failure	Rate of new or worsening heart failure at 5 years	5 years
Other	Rate of new or worsening heart failure	Rate of new or worsening heart failure at 1 year	1 year
Primary	Rate of all-cause mortality	Rate of all-cause mortality at 1 year	1 year
Secondary	Rate of all-cause mortality	Rate of all-cause mortality at 5 years	5 years
Secondary	Rate of cardiovascular mortality	Rate of cardiovascular mortality at 5 years	5 years