Ignite Creation Date:
2024-05-06 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03654157
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2018-08-29
Brief Title:
ACS Registry - A Non-interventional Study to Estimate the Rates of Outcomes in ACS Patients in Moscow
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Non-interventional Study to Estimate the Rates of Outcomes in ACS Patients in Moscow
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None