Clinical trial NCT03654157: ACS Registry - A Non-interventional Study to Estimate the Rates of Outcomes in ACS Patients in Moscow
Official title: A Non-interventional Study to Estimate the Rates of Outcomes in ACS Patients in Moscow
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Attack
Stroke
Cardiovascular Death
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-08-31
Enrollment: 1576
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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


Eligibility 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

Primary outcomes:
measure: the cumulative incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACСE)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow/Russia
Study officials:
affiliation: GBUZ GP # 121 DZM
name: Olga Pesheva
role: PRINCIPAL_INVESTIGATOR
affiliation: GBUZ GP # 52 DZM
name: Tatyana Yurchak
role: PRINCIPAL_INVESTIGATOR
affiliation: GBUZ GP # 2 DZM
name: Veronika Vovk
role: PRINCIPAL_INVESTIGATOR
affiliation: GBUZ GKB # 51 DZM
name: Dmitriy Privalov
role: PRINCIPAL_INVESTIGATOR
affiliation: GBUZ GKB # 13 DZM
name: Maria Klepikova
role: PRINCIPAL_INVESTIGATOR
affiliation: GBUZ GP # 218 DZM
name: Olga Belkorey
role: PRINCIPAL_INVESTIGATOR
affiliation: GBUZ GP # 19 DZM
name: Natalya Karabinskaya
role: PRINCIPAL_INVESTIGATOR
affiliation: GBUZ GP # 19 DZM
name: Natalya Bosyakova
role: PRINCIPAL_INVESTIGATOR
affiliation: GBUZ GP # 107 DZM
name: Marina Lepatova
role: PRINCIPAL_INVESTIGATOR
affiliation: FGBU "Polyclinic # 1" Administrative Department of the President of the Russian Federation
name: Elena Dorofeeva
role: PRINCIPAL_INVESTIGATOR
affiliation: GBUZ GP # 109 DZM
name: Irina Shoshina
role: PRINCIPAL_INVESTIGATOR
affiliation: GBUZ GP # 23 DZM
name: Darya Semenova
role: PRINCIPAL_INVESTIGATOR
affiliation: GBUZ KDC # 2 DZM
name: Elena Zherebetskaya
role: PRINCIPAL_INVESTIGATOR
affiliation: GBUZ GP # 175 DZM
name: Marina Yarygina
role: PRINCIPAL_INVESTIGATOR
affiliation: GBUZ GP # 115 DZM
name: Elena Lukinskaya
role: PRINCIPAL_INVESTIGATOR
affiliation: GBUZ GP # 209 DZM
name: Irina Borovikova
role: PRINCIPAL_INVESTIGATOR
affiliation: GBUZ GP # 22 DZM
name: Tatiana Sladkova
role: PRINCIPAL_INVESTIGATOR
affiliation: GBUZ GP # 64 DZM
name: Elena Demyanova
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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, 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.
citation: 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.
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. No abstract available. Russian.
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.
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, 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.
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. No abstract available.