An observational study in Heart Attack, Stroke and Cardiovascular Death, sponsored by AstraZeneca. Completed at 27 sites in Russian Federation. Per ClinicalTrials.gov, last updated 2022-10-14.
Sponsored by AstraZeneca · Observational
Cardiovascular diseases (CVD) are currently the leading cause of death in industrialized countries and are expected to become the leading cause of death in emerging countries by 20201. According to the official Russian statistics, in 2015, CVD was the cause in 34% of deaths in Russia2.
Acute Coronary Syndrome (ACS) is the most prevalent manifestation of CVD and is associated with high mortality and morbidity. No other life-threatening disease is as prevalent or expensive to society3. In 2014 in Russian Federation 46 250 people died from acute myocardial infarction (MI) and 17 605 people died from recurrent MI4.
ACS is a clinical syndrome characterized by unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI). The most common cause of ACS is reduced myocardial perfusion that results from coronary artery narrowing caused by the formation of partially or totally occlusive thrombi in response to rupture of atherosclerotic plaques on the vessel wall5-7.
In Russian Federation ACS management after ACS is provided in out-patient settings by doctors of different specialties (cardiologists and general practitioners (GPs)). However, the management of ACS in out-patient settings in some regions in Russian Federation is frequently suboptimal. Moscow city significantly differs from other parts of Russia from ACS management at hospital stage (up to 90% of PCI managed ST elevation myocardial infarction (MI) patients, no thrombolysis, short first medical contact to balloon time etc.) but it is unclear if management of post MI patients in Moscow out-patient settings is also optimal. In-hospital mortality in MI patients decreased last years but there is no data on clinical outcomes during 12 months after MI in Moscow.
This study will provide the epidemiological data about rates of major adverse cardiovascular and cerebrovascular events (MACCE) (MI, stroke, cardiovascular death) within 12 months after MI in real clinical practice in Moscow and describe DAPT at out-patient setting. The information received in this study will help to optimize management of Russian patients with ACS. The data will be used in discussion with payers
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 1,576 is above the median of 500 across 983 observational studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
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All consecutive patients who survived myocardial infarction and who come for further treatment and observation to polyclinic after discharge from hospital will be enrolled in this study if a patient provides a consent form. It is estimated that at least 2500 post MI patients are to be enrolled in the study. It is also assumed that the total size of the study population could be up to 10 000 post MI patients who are observed in polyclinics of Moscow city within first year after index event.
The subject population that will be observed in this prospective study must meet the following criteria:
Exclusion Criteria:
the cumulative incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACСE)
The primary objective of this study is to describe the cumulative incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACСE) \[MI, stroke, and cardiovascular death\] observed over 1 year after index MI in all patients enrolled in the study.
Time frame: 1 year
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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