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Аn international, multicenter, non-interventional real-life clinical practice Register studying the Actual therapeutic patient population with Multifocal Atherosclerosis in the Russian Federation and Eurasian countries
Information on demographics, comorbidities, methods for diagnosing multifocal atherosclerosis (MFA), prescribed therapy, and outcomes will be identified via medical records analysis. Results of arterial bed ultrasound examination (US), results of ankle-brachial index (ABI) measurements, along with clinical and anamnestic data on target organ damage in the MFA-affected areas will be used as the main source verifying the presence MFA.
The follow-up period for each patient will span from the date of inclusion and over the next year with an additional 6 and 12 months of follow-up.
Patients eligible for entry in the Register must be included and their details must be documented. The procedure for obtaining informed consent for the examination and collection of data must comply with the requirements of local legislation. Patients will be required to sign an informed consent document if required.
Standardized electronic CRFs will be used in all research centers. The electronic data collection (EDC) system must be validated in accordance with current standards and legal requirements. Researchers will log into this system using individually assigned usernames and passwords. Data can only be entered and corrected by the researcher or other authorized personnel of the research center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with MFA | Patients with MFA confirmed by ultrasound examination, ABI or using clinical and medical history data. | ||
| Patients with a history of established isolated coronary artery disease | The criterion for inclusion of patients in the present study is the diagnosed ischemic heart disease. |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of a cardiovascular event (stroke, ACS, amputation, hospitalizations (related or not to cardiovascular pathology), the number of emergency calls) | To assess the occurrence of cardiovascular events in 6 and 12 months in a cohort of patients with MFA: brain hemorrhage, acute coronary syndrome, amputation, admission to hospital (related or not related to a cardiovascular disease), number of emergency calls | after 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | To estimate overall mortality at 6 and 12 months in a cohort of patients with MFA | after 12 months |
| The frequency of any bleeding episodes (life-threatening, bothersome, or of unknown severity) |
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Inclusion Criteria:
Men or women aged 18 and older at the time of data registration; Presence of 2 or more of the following factors
Presence of one or more of the following atherosclerotic risk factors:
Exclusion Criteria:
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Anonymized male and female patients over 18 years and suffering MFA confirmed by ultrasound method, ankle-brachial index along with clinical and anamnestic data.
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Arutyunov, professor | Eurasian Association of Therapists | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurasian Association of Therapists | Moscow | Russia |
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| Label | URL |
|---|---|
| Study design | View source |
| Peculiarities of polyvascular disease and the diagnostic significance of the ankle-brachial index in patients with coronary artery disease: results from the real-world registry KAMMA | View source |
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To evaluate bleeding at 6 and 12 months in a cohort of patients with MFA
| after 12 months |
| Change of GFR according to Chronic Kidney Disease Epidemiology Collaboration | To compare the course of CKD in different subpopulations of patients | after 12 months |
| Prevalence of risk factors in the population | To estimate the prevalence of risk factors in the population | after 12 months |
| Change of 3 point major adverse cardiovascular events parameter (Cardiovascular death, Nonfatal stroke, Non-fatal myocardial infarction) | To evaluate patients according to 3P MACE parameter ((Cardiovascular death, Nonfatal stroke, Non-fatal myocardial infarction) according to prescribed therapy | after 12 months |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D002318 | Cardiovascular Diseases |
| D003643 | Death |
| D051436 | Renal Insufficiency, Chronic |
| D006470 | Hemorrhage |
| D020521 | Stroke |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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