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

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

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Chronic Kidney Diseases; Atherosclerosis; Bleeding; Acute Coronary Syndrome; Cardiac Death; Acute Stroke; Polyvascular Disease; Atherosclerosis Generalized

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 Type: Observational
• Enrollment (Actual): 3059

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Eurasian Association of Therapists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Eurasian Association of Therapists
• Investigators: Study Chair: Alexander Arutyunov, professor, Eurasian Association of Therapists

Publications and helpful links

Helpful Links

• Study design
• 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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Atherosclerosis; bleeding; acute coronary syndrome; cardiovascular diseases; Chronic kidney disease; hospitalization; cerebrovascular accident; amputation; cardiovascular event; acute stroke; cardiac death; polyvascular disease
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Stroke; Cardiovascular Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Death; Atherosclerosis; Acute Coronary Syndrome
• Other Study ID Numbers: KAMMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No