Clinical Register Studying the therApeutic Patient Population With Multifocal Atherosclerosis

Cardiovascular Diseases Clinical Trial

— KAMMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05189847
• Other study ID #: KAMMA
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: Eurasian Association of Therapists
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3059
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Stroke
• Atherosclerosis
• Bleeding
• Cardiac Death
• Cardiovascular Diseases
• Chronic Kidney Diseases
• Death
• Kidney Diseases
• Polyvascular Disease
• Renal Insufficiency, Chronic
• Stroke

Locations

Country	Name	City	State
Russian Federation	Eurasian Association of Therapists	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Eurasian Association of Therapists

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All-cause mortality	To estimate overall mortality at 6 and 12 months in a cohort of patients with MFA	after 12 months
Secondary	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
Secondary	Change of GFR according to Chronic Kidney Disease Epidemiology Collaboration	To compare the course of CKD in different subpopulations of patients	after 12 months
Secondary	Prevalence of risk factors in the population	To estimate the prevalence of risk factors in the population	after 12 months
Secondary	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