Clinical Register Studying the therApeutic Patient Population With Multifocal Atherosclerosis (KAMMA)

Eurasian Association of Therapists

Status

Completed

Conditions

Cardiac Death

Chronic Kidney Diseases

Polyvascular Disease

Atherosclerosis Generalized

Acute Coronary Syndrome

Cardiovascular Diseases

Acute Stroke

Atherosclerosis

Bleeding

Study type

Observational

Funder types

Other

Identifiers

NCT05189847

KAMMA

Details and patient eligibility

About

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

Full 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.

Enrollment

3,059 patients

Sex

All

Ages

18+ years old

Volunteers

No 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).

Exclusion criteria