Personalized Risk of Rapidly Progressive Atherosclerosis

NCT05492084 | Completed DMC

• 1 other identifier: L-001
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

Вackground. Progressive atherosclerosis is accompanied by unfavorable clinical outcomes, study and understanding of this process, creation of risk assessment method is necessary for individualization of approaches to treatment and prevention of this condition. Purpose of the study. Creation of a mathematical model to assess the risk of accelerated atherosclerosis development, using methods of factor and correlation analysis. Patient Characteristics and Study Methods. A retrospective cohort study included 202 patients with coronary heart disease. Group 1 included patients who had had myocardial infarction or unstable angina, emergency arterial stenting, stroke, peripheral artery thrombosis, critical ischemia, and lower extremity amputation within 2 years before study inclusion. Patients in the comparison group did not have these events. The influence of each of the studied parameters on the probability of fast progressing atherosclerosis was determined by factor and correlation analysis. The prospective part of the study will include follow-up of patients from both groups for 12 months. Annual "endpoints": fatal outcome, unscheduled coronary revascularization, nonfatal myocardial infarction and stroke, hospitalization due to unstable angina pectoris, stent thrombosis, stenting/plasty of lower limb arteries.

Conditions

Atherosclerosis, Coronary

Keywords

rapidly progressive atherosclerosis; personalized risk

Outcome Measures

Primary Outcomes (1)

• death, MI, stroke

  The analysis will be performed using the SPSS REGRESSION module

  2 years

Secondary Outcomes (1)

• total mortality

  1 year

Study Arms (2)

active group

The first - active group (100 people) included patients who had type 1 myocardial infarction (MI) (54 people) within 2 years prior to the study or the diagnosis of CAD was established according to selective coronary angiography: the presence lumen stenosis of at least two coronary arteries by 50 % or more (46 people) and an additional two (or more) cardiovascular events from the following: MI or unstable angina, emergency arterial stenting, stroke, peripheral arterial thrombosis, critical ischemia, and lower limb amputation. The combination of two or more of these cardiovascular events that occurred within two years indicated the rapid progression of atherosclerosis in these patients.

Other: without Intervention

comparison group

The second (comparison group) included 102 patients with confirmed coronary heart disease in a similar way (55 people had only 1 type 1 MI in the past and 45 had coronary artery disease confirmed by selective coronary angiography, respectively), in whom two years before inclusion in the study there were no cardiovascular events from the above, which indicated the spontaneous course of atherosclerosis.

Other: without Intervention

Interventions

without Intervention OTHER

without Intervention

active group; comparison group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A retrospective cohort study included 202 patients with coronary heart disease. Group 1 included patients who had had myocardial infarction or unstable angina, emergency arterial stenting, stroke, peripheral artery thrombosis, critical ischemia, and lower extremity amputation within 2 years before study inclusion. Patients in the comparison group did not have these events. The influence of each of the studied parameters on the probability of fast progressing atherosclerosis was determined by factor and correlation analysis.

You may qualify if:

• who had had a type 1 myocardial infarction (MI) within two years prior to the study or had been diagnosed with CAD by selective coronary angiography: the presence of lumen stenosis of at least two coronary arteries of 50% or more and two (or more) additional cardiovascular events of the following: MI or unstable angina, emergency artery stenting, stroke, peripheral artery thrombosis, critical ischemia and lower limb amputation
• signed informed consent

You may not qualify if:

• patients with obstructive, dilated and restrictive cardiomyopathy, valve heart disease, malignant neoplasms, with acute inflammatory processes of the liver, kidneys, endocrine glands and other organs and systems, and chronic diseases in the phase of acute and incomplete remission; with diabetes mellitus type 1 and 2; atrial fibrillation of any type, severe hepatic and renal failure; chronic alcoholism and mental disorders, lack of signed voluntary informed consent

Sponsors & Collaborators

• Novosibirsk State Medical University: lead
• Novosibirsk State University: collaborator

Study Sites (1)

Novosibirsk State Medical University

Novosibirsk, Novosibirskaja Oblast' (oblast'), 630099, Russia

Location

Biospecimen

Retention: SAMPLES WITH DNA

frozen blood clot

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Methods

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Olga M. Parkhomenko

  Novosibirsk State Medical University, Novosibirsk, Krasny pr 52, Russia

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of the Novosibirsk State Medical University

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 8, 2022
• Study Start: January 1, 2019
• Primary Completion: January 1, 2019
• Study Completion: January 31, 2019
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)