KAMMA: Clinical Register Studying the therApeutic Patient Population With Multifocal Atherosclerosis

Sponsor

Eurasian Association of Therapists (Other)

Overall Status

Recruiting

CT.gov ID

NCT05189847

Collaborator

(none)

3,600

Enrollment

Location

12.9

Anticipated Duration (Months)

278.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Polyvascular Disease Atherosclerosis Atherosclerosis Generalized Cardiovascular Diseases Cardiac Death Chronic Kidney Diseases Bleeding Acute Stroke Acute Coronary Syndrome

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

3600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Clinical Register Studying the therApeutic Patient Population With Multifocal Atherosclerosis in the Russian Federation and Eurasian Countries

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Occurrence of a cardiovascular event (stroke, ACS, amputation, hospitalizations (related or not to cardiovascular pathology), the number of emergency calls) [after 12 months]
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

Secondary Outcome Measures

All-cause mortality [after 12 months]
To estimate overall mortality at 6 and 12 months in a cohort of patients with MFA
The frequency of any bleeding episodes (life-threatening, bothersome, or of unknown severity) [after 12 months]
To evaluate bleeding at 6 and 12 months in a cohort of patients with MFA
Change of GFR according to Chronic Kidney Disease Epidemiology Collaboration [after 12 months]
To compare the course of CKD in different subpopulations of patients
Prevalence of risk factors in the population [after 12 months]
To estimate the prevalence of risk factors in the population
Change of 3 point major adverse cardiovascular events parameter (Cardiovascular death, Nonfatal stroke, Non-fatal myocardial infarction) [after 12 months]
To evaluate patients according to 3P MACE parameter ((Cardiovascular death, Nonfatal stroke, Non-fatal myocardial infarction) according to prescribed therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).