Clinical trial NCT05189847: Clinical Register Studying the therApeutic Patient Population With Multifocal Atherosclerosis
Official title: Clinical Register Studying the therApeutic Patient Population With Multifocal Atherosclerosis in the Russian Federation and Eurasian Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polyvascular Disease
Atherosclerosis
Atherosclerosis Generalized
Cardiovascular Diseases
Cardiac Death
Chronic Kidney Diseases
Bleeding
Acute Stroke
Acute Coronary Syndrome
Keywords: Atherosclerosis
polyvascular disease
cardiovascular diseases
acute stroke
acute coronary syndrome
cardiac death
Chronic kidney disease
bleeding
hospitalization
amputation
cardiovascular event
cerebrovascular accident
Lead sponsor: Eurasian Association of Therapists
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 3059
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Anonymized male and female patients over 18 years and suffering MFA confirmed by ultrasound method, ankle-brachial index along with clinical and anamnestic data.

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Men or women aged 18 and older at the time of data registration; Presence of 2 or more of the following factors

  * Coronary arteries atherosclerosis (atherosclerosis revealed by means of coronary angiography and/or a history of type I myocardial infarction and/or elective PCI and/or CABG and/or angina pectoris with ischemia according to stress test results, history of CHD);
  * Lower extremity arteries atherosclerosis (atherosclerotic plaques revealed by ultrasound, and/or ABI \<0.9, and/or a history of revascularization, and/or a history of amputation associated due to chronic lower extremities arterial insufficiency);
  * Atherosclerosis of brachiocephalic arteries or renal arteries (presence of atherosclerotic plaques according to US data and/or history of revascularization and/or history of atherothrombotic stroke or TIA in the absence of known AF);
  * Atherosclerosis of renal arteries or abdominal aorta (presence of atherosclerotic plaques according to US data and/or history of revascularization).

Presence of one or more of the following atherosclerotic risk factors:

* Anamnestic data on dyslipidemia with LDL cholesterol levels above 4.9 mmol/L or total cholesterol levels above 8.0 mmol/L;
* Presence of confirmed familial hypercholesterolemia;
* Current smoker status or history of smoking;
* Overweight (BMI≥ 25 kg/m2);
* Presence of arterial hypertension;
* Presence of established type 2 diabetes mellitus;
* Presence of an established diagnosis of prediabetes;
* Presence of CKD stage 3a and higher (GFR \<60 ml / min / 1.73 m2).

Exclusion Criteria:

* Life expectancy less than 1 year;
* Patient refusal to participate in the Register

Primary outcomes:
measure: Occurrence of a cardiovascular event (stroke, ACS, amputation, hospitalizations (related or not to cardiovascular pathology), the number of emergency calls)
timeFrame: after 12 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: after 12 months
measure: The frequency of any bleeding episodes (life-threatening, bothersome, or of unknown severity)
timeFrame: after 12 months
measure: Change of GFR according to Chronic Kidney Disease Epidemiology Collaboration
timeFrame: after 12 months
measure: Prevalence of risk factors in the population
timeFrame: after 12 months
measure: Change of 3 point major adverse cardiovascular events parameter (Cardiovascular death, Nonfatal stroke, Non-fatal myocardial infarction)
timeFrame: after 12 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Eurasian Association of Therapists
Study officials:
affiliation: Eurasian Association of Therapists
name: Alexander Arutyunov, professor
role: STUDY_CHAIR
References: