Clinical Register Studying the therApeutic Patient Population With Multifocal Atherosclerosis

NCT ID: NCT05189847

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3059 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2024-01-31

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.

Conditions

Polyvascular Disease; Atherosclerosis; Atherosclerosis Generalized; Cardiovascular Diseases; Cardiac Death; Chronic Kidney Diseases; Bleeding; Acute Stroke; Acute Coronary Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with MFA

Patients with MFA confirmed by ultrasound examination, ABI or using clinical and medical history data.

No interventions assigned to this group

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurasian Association of Therapists

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Arutyunov, professor

Role: STUDY_CHAIR

Eurasian Association of Therapists

Locations

Eurasian Association of Therapists

Moscow, , Russia

Countries

Russia

Related Links

http://doi.org/10.17802/2306-1278-2023-12-2-6-13

Study design

http://doi.org/10.15829/1560-4071-2024-5837

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

Other Identifiers

KAMMA

Identifier Type: -

Identifier Source: org_study_id