- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04506047
Acute and Long-term Outcomes of Patients With Acute Myocardial Infarction Treated With PCI (SINERGY-ACUTE)
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).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Goran Stankovic, MD, PhD
- Phone Number: +381113613653
- Email: gorastan@gmail.com
Study Locations
-
-
-
Belgrade, Serbia, 11000
- Recruiting
- Clinical Centre of Serbia, Department of Cardiology
-
Contact:
- Goran Stankovic, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Acute Myocardial Infarction
Consecutive patients with acute myocardial infarction
|
Percutaneous Coronary Intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of all-cause mortality
Time Frame: 1 year
|
Rate of all-cause mortality at 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of all-cause mortality
Time Frame: 5 years
|
Rate of all-cause mortality at 5 years
|
5 years
|
Rate of cardiovascular mortality
Time Frame: 5 years
|
Rate of cardiovascular mortality at 5 years
|
5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of myocardial infarction
Time Frame: 5 years
|
Rate of myocardial infarction at 5 years
|
5 years
|
Rate of repeat revascularization
Time Frame: 5 years
|
Rate of repeat revascularization at 5 years
|
5 years
|
Rate of stroke
Time Frame: 5 years
|
Rate of stroke at 5 years
|
5 years
|
Rate of new or worsening heart failure
Time Frame: 5 years
|
Rate of new or worsening heart failure at 5 years
|
5 years
|
Rate of new or worsening heart failure
Time Frame: 1 year
|
Rate of new or worsening heart failure at 1 year
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 570/11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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