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ACS Registry - A Non-interventional Study to Estimate the Rates of Outcomes in ACS Patients in Moscow

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ClinicalTrials.gov Identifier: NCT03654157
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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


Condition or disease
Heart Attack Stroke Cardiovascular Death

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Non-interventional Study to Estimate the Rates of Outcomes in ACS Patients in Moscow
Actual Study Start Date : March 25, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020



Primary Outcome Measures :
  1. the cumulative incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACСE) [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

The subject population that will be observed in this prospective study must meet the following criteria:

  1. Patients survivors who visited outpatient setting after discharge from hospital due to MI (STEMI or NSTEMI) within 1 month after discharge from hospital;
  2. Obtained written informed consent for participation in this study.
  3. Age of 18 year or older.

Exclusion Criteria:

  1. Current participation in a clinical study.
  2. Unknown type of MI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654157


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Russian Federation
Research Site Recruiting
Moscow, D1843r00279, Russian Federation
Principal Investigator: Olga Pesheva         
Research Site Recruiting
Moscow, D1843r00279, Russian Federation
Principal Investigator: Tatyana Yurchak         
Research Site Recruiting
Moscow, D1843r00279, Russian Federation
Principal Investigator: Veronika Vovk         
Research Site Recruiting
Moscow, D1843r00279, Russian Federation
Principal Investigator: Dmitriy Privalov         
Research Site Recruiting
Moscow, D1843r00279, Russian Federation
Principal Investigator: Maria Klepikova         
Research Site Recruiting
Moscow, D1843r00279, Russian Federation
Principal Investigator: Olga Belkorey         
Research Site Recruiting
Moscow, D1843r00279, Russian Federation
Principal Investigator: Natalya Karabinskaya         
Research Site Recruiting
Moscow, D1843r00279, Russian Federation
Principal Investigator: Marina Lepatova         
Research Site Recruiting
Moscow, D1843r00279, Russian Federation
Principal Investigator: Elena Dorofeeva         
Research Site Recruiting
Moscow, D1843r00279, Russian Federation
Principal Investigator: Irina Shoshina         
Research Site Recruiting
Moscow, D1843r00279, Russian Federation
Principal Investigator: Darya Semenova         
Research Site Recruiting
Moscow, D1843r00279, Russian Federation
Principal Investigator: Elena Zherebetskaya         
Research Site Recruiting
Moscow, D1843r00279, Russian Federation
Principal Investigator: Marina Yarygina         
Research Site Recruiting
Moscow, D1843r00279, Russian Federation
Principal Investigator: Elena Lukinskaya         
Research Site Recruiting
Moscow, D1843r00279, Russian Federation
Principal Investigator: Irina Borovikova         
Research Site Recruiting
Moscow, D1843r00279, Russian Federation
Principal Investigator: Tatiana Sladkova         
Research Site Recruiting
Moscow, D1843r00279, Russian Federation
Principal Investigator: Elena Demyanova         
Research Site Recruiting
Moscow, D1843r00279, Russian Federation
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Olga Pesheva GBUZ GP # 121 DZM
Principal Investigator: Tatyana Yurchak GBUZ GP # 52 DZM
Principal Investigator: Veronika Vovk GBUZ GP # 2 DZM
Principal Investigator: Dmitriy Privalov GBUZ GKB # 51 DZM
Principal Investigator: Maria Klepikova GBUZ GKB # 13 DZM
Principal Investigator: Olga Belkorey GBUZ GP # 218 DZM
Principal Investigator: Natalya Karabinskaya GBUZ GP # 19 DZM
Principal Investigator: Natalya Bosyakova GBUZ GP # 19 DZM
Principal Investigator: Marina Lepatova GBUZ GP # 107 DZM
Principal Investigator: Elena Dorofeeva FGBU "Polyclinic # 1" Administrative Department of the President of the Russian Federation
Principal Investigator: Irina Shoshina GBUZ GP # 109 DZM
Principal Investigator: Darya Semenova GBUZ GP # 23 DZM
Principal Investigator: Elena Zherebetskaya GBUZ KDC # 2 DZM
Principal Investigator: Marina Yarygina GBUZ GP # 175 DZM
Principal Investigator: Elena Lukinskaya GBUZ GP # 115 DZM
Principal Investigator: Irina Borovikova GBUZ GP # 209 DZM
Principal Investigator: Tatiana Sladkova GBUZ GP # 22 DZM
Principal Investigator: Elena Demyanova GBUZ GP # 64 DZM

Publications:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03654157     History of Changes
Other Study ID Numbers: D1843R00279
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases