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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03654157
• Other study ID #: D1843R00279
• Status: Completed
• Start date: March 25, 2018
• Est. completion date: October 19, 2021

Study information

• Verified date: October 2022
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1576
• Est. completion date: October 19, 2021
• Est. primary completion date: October 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Death
• Heart Attack
• Myocardial Infarction
• Stroke

Locations

Country	Name	City	State
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia
Russian Federation	Research Site	Moscow	Moscow/Russia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

References & Publications (7)

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. Erratum in: J Am Coll Cardiol 2001 Jul;38(1):294-5. — View Citation

Davies MJ. The pathophysiology of acute coronary syndromes. Heart. 2000 Mar;83(3):361-6. Review. — View Citation

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. Erratum in: J Am Coll Cardiol. 2015 Aug 25;66(8):982. — View Citation

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. — View Citation

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, Fernández-Avilés 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. Epub 2007 Jun 14. — View Citation

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. Russian. — View Citation

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, Thorsén 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the cumulative incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MAC?E)	The primary objective of this study is to describe the cumulative incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MAC?E) [MI, stroke, and cardiovascular death] observed over 1 year after index MI in all patients enrolled in the study.	1 year

External Links

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