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

October 13, 2022 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1576

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Moscow/Russia
      • Moscow, Moscow/Russia, Russian Federation, 105264
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 107023
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 107564
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 109431
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 109451
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 109548
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 111401
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 115211
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 115280
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 115446
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 115551
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 117042
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 117218
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 117546
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 117556
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 119002
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 119180
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 119607
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 119633
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 121309
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 121374
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 123308
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 124365
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 124489
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 125993
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 127273
        • Research Site
      • Moscow, Moscow/Russia, Russian Federation, 127642
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2018

Primary Completion (Actual)

October 19, 2021

Study Completion (Actual)

October 19, 2021

Study Registration Dates

First Submitted

August 29, 2018

First Submitted That Met QC Criteria

August 29, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1843R00279

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

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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