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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03654157

Recruitment Status : Completed

First Posted : August 31, 2018

Last Update Posted : October 14, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

Study Description

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

Study Design

Layout table for study information

Study Type :	Observational
Actual Enrollment :	1576 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
Actual Primary Completion Date :	October 19, 2021
Actual Study Completion Date :	October 19, 2021

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

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:

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

Exclusion Criteria:

Current participation in a clinical study.
Unknown type of MI

Contacts and Locations

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

Locations

Layout table for location information

Russian Federation
Research Site
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

Sponsors and Collaborators

AstraZeneca

Investigators

Layout table for investigator information

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

More Information

Additional Information:

CSR synopsis redacted This link exits the ClinicalTrials.gov site

Publications:

Davies MJ. The pathophysiology of acute coronary syndromes. Heart. 2000 Mar;83(3):361-6. doi: 10.1136/heart.83.3.361. No abstract available.

Task Force for Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes of European Society of Cardiology; Bassand JP, Hamm CW, Ardissino D, Boersma E, Budaj A, Fernandez-Aviles F, Fox KA, Hasdai D, Ohman EM, Wallentin L, Wijns W. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. Eur Heart J. 2007 Jul;28(13):1598-660. doi: 10.1093/eurheartj/ehm161. Epub 2007 Jun 14. No abstract available.

Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, Jones RH, Kereiakes D, Kupersmith J, Levin TN, Pepine CJ, Schaeffer JW, Smith EE 3rd, Steward DE, Theroux P, Alpert JS, Eagle KA, Faxon DP, Fuster V, Gardner TJ, Gregoratos G, Russell RO, Smith SC Jr. ACC/AHA guidelines for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Unstable Angina). J Am Coll Cardiol. 2000 Sep;36(3):970-1062. doi: 10.1016/s0735-1097(00)00889-5. No abstract available. Erratum In: J Am Coll Cardiol 2001 Jul;38(1):294-5.

Vasilyeva EY, Plavunov NF, Kalinskaya AI, Sapina AI, Vvedensky GA, Lebedeva AY, Skrypnyk DV, Shpektor AV. [Treatment of Patients With Acute Myocardial Infarction With ST-Segment Elevation. Organization of the Myocardial Infarction Network in Moscow]. Kardiologiia. 2016 Dec;56(12):48-53. No abstract available. Russian.

Jernberg T, Hasvold P, Henriksson M, Hjelm H, Thuresson M, Janzon M. Cardiovascular risk in post-myocardial infarction patients: nationwide real world data demonstrate the importance of a long-term perspective. Eur Heart J. 2015 May 14;36(19):1163-70. doi: 10.1093/eurheartj/ehu505. Epub 2015 Jan 13.

Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.

Hicks KA, Tcheng JE, Bozkurt B, Chaitman BR, Cutlip DE, Farb A, Fonarow GC, Jacobs JP, Jaff MR, Lichtman JH, Limacher MC, Mahaffey KW, Mehran R, Nissen SE, Smith EE, Targum SL. 2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards). J Am Coll Cardiol. 2015 Jul 28;66(4):403-69. doi: 10.1016/j.jacc.2014.12.018. Epub 2014 Dec 29. No abstract available. Erratum In: J Am Coll Cardiol. 2015 Aug 25;66(8):982.

Layout table for additonal information

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT03654157
Other Study ID Numbers:	D1843R00279
First Posted:	August 31, 2018 Key Record Dates
Last Update Posted:	October 14, 2022
Last Verified:	October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
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.
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.
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.
URL:	https://astrazenecagroup-dt.pharmacm.com/DT/Home

Additional relevant MeSH terms:

Layout table for MeSH terms

Myocardial Infarction Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases	Infarction Ischemia Pathologic Processes Necrosis

To Top