Clinical Register Studying the therApeutic Patient Population With Multifocal Atherosclerosis

NCT05189847 | Completed DMC

• 1 other identifier: KAMMA
• Study Type: observational
• Target: 3,059
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Atherosclerosis; polyvascular disease; cardiovascular diseases; acute stroke; acute coronary syndrome; cardiac death; Chronic kidney disease; bleeding; hospitalization; amputation; cardiovascular event; cerebrovascular accident

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• All-cause mortality

  after 12 months

• The frequency of any bleeding episodes (life-threatening, bothersome, or of unknown severity)

  after 12 months

• Change of GFR according to Chronic Kidney Disease Epidemiology Collaboration

  after 12 months

• 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)

  after 12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• Life expectancy less than 1 year;
• Patient refusal to participate in the Register

Sponsors & Collaborators

• Eurasian Association of Therapists: lead

Study Sites (1)

Eurasian Association of Therapists

Moscow, Russia

Location

Related 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

MeSH Terms

Conditions

Atherosclerosis; Cardiovascular Diseases; Death; Renal Insufficiency, Chronic; Hemorrhage; Stroke; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Myocardial Ischemia; Heart Diseases

Study Officials

• Alexander Arutyunov, professor

  Eurasian Association of Therapists

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 13, 2022
• Study Start: February 1, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)