Prediction of Primary Cardiovascular Events Using the Multimarker Approach

NCT05704569 | Completed

• 1 other identifier: CV risk markers
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study of biochemical risk factors for cardiovascular diseases is important not only for analysis, but also for preventive measures, given that changes in the level of biomarkers can be detected before the first clinical manifestations of CVD. Accordingly, patients at high CV risk may have additional motivation to lead a healthy lifestyle. In addition, information on biochemical risk markers can be used to optimize the clinical management of patients.

Conditions

Cardiovascular Diseases; Stroke; Myocardial Infarction; Death; Coronary Artery Disease

Keywords

CVD; biomarkers; prognosis; MI; stroke; CV mortality; CV morbidity

Outcome Measures

Primary Outcomes (3)

• number of respondents with stroke or transient ischemic attack

  stroke was defined as a sudden onset of nonconvulsive and focal neurological deficit due to ischemia or hemorrhage that lasts \>24 hours, and it is transient ischemic attack if neurological recovery occurred within 24 hours. \&e diagnosis of stroke and the transient ischemic attack was based on the disease history, neurological examination, and all available clinical data, including computed tomography (CT)/magnetic resonance imaging (MRI) results.

  66 months

• Number of respondents with Coronary heart disease

  Coronary heart disease included myocardial infarction, sudden cardiac death, and newly diagnosed angina. The criteria for MI were at least two of the following: (1) typical symptoms, including prolonged severe anterior chest pain; (2) elevated cardiac enzymes-higher than twice the upper limit of the standard values; sudden cardiac death within 1 hour of the acute condition onset; (3) progressive diagnostic electrocardiographic changes. The cases of newly diagnosed angina were determined based on typical angina-type pain, reversed by the use of nitrates, confirmed by a doctor's examination, and via the electrocardiography (ECG) exercise test.

  66 months

• Number Of respondents wirh cardiovascular death

  death reported as a complication of cardiovascular disease

  66 months

Study Arms (2)

the outcome group

The composite endpoint included the presence of any of the following events: cardiovascular death, MI, stroke, hospitalization and/or application due to CHD, and transient ischemic attack

Diagnostic Test: measurement of multiple biomarkers

no-outcome group

individuals who did not experience any events during the observation period

Diagnostic Test: measurement of multiple biomarkers

Interventions

measurement of multiple biomarkers DIAGNOSTIC_TEST

All patients were tested for glucose and cholesterol levels. The capillary blood glucose level was measured by an electrochemical method using an Accu-Chek Active by AkkuChek blood glucose meter. The DM was considered to be verified when there were criteria which the World Health Organization (WHO) set in 2001: glucose concentration in whole blood is \>6.1 mmol/l, and glucose concentration is \>11.1 mmol/l in random measurement. Plasma for the study was obtained via the standard phlebotomy technique from ethylenediaminetetraacetic acid (EDTA) anticoagulants. Plasma was aliquoted into cryovials and got frozen quickly. The samples were stored in a low-temperature refrigerator (-70°C) until the study commencement (up to 3 months). All biomarkers were measured by magnetic bead-based multiplex immunofluorescence assay through the Xmap technology using the Milliplex map Human CVD Magnetic Bead Panel 1 (Millipore)

no-outcome group; the outcome group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

persons living in the Republic of Kazakhstan, aged 25 to 65 years without previous cardiovascular events

You may qualify if:

• respondents living in the territory of the Republic of Kazakhstan from 25 to 65 years without previous cardiovascular events.

You may not qualify if:

• pregnant women;
• persons with mental and severe neurological diseases;
• survivors of an acute event associated with atherosclerosis;
• persons with diagnosed chronic forms of coronary artery disease;
• persons with verified CHF;
• persons with myocarditis and cardiomyopathies of various origins,
• congenital and acquired heart defects,
• atherosclerosis of peripheral arteries.

Sponsors & Collaborators

• Karaganda Medical University: lead

Related Publications (6)

• Pareek M, Bhatt DL, Vaduganathan M, Biering-Sorensen T, Qamar A, Diederichsen AC, Moller JE, Hindersson P, Leosdottir M, Magnusson M, Nilsson PM, Olsen MH. Single and multiple cardiovascular biomarkers in subjects without a previous cardiovascular event. Eur J Prev Cardiol. 2017 Oct;24(15):1648-1659. doi: 10.1177/2047487317717065. Epub 2017 Jun 23.

  PMID: 28644092 RESULT

• Pauli N, Puchalowicz K, Kuligowska A, Krzystolik A, Dziedziejko V, Safranow K, Rac M, Chlubek D, Ewa Rac M. Associations between IL-6 and Echo-Parameters in Patients with Early Onset Coronary Artery Disease. Diagnostics (Basel). 2019 Nov 14;9(4):189. doi: 10.3390/diagnostics9040189.

  PMID: 31739518 RESULT

• Shi C, van der Wal HH, Sillje HHW, Dokter MM, van den Berg F, Huizinga L, Vriesema M, Post J, Anker SD, Cleland JG, Ng LL, Samani NJ, Dickstein K, Zannad F, Lang CC, van Haelst PL, Gietema JA, Metra M, Ameri P, Canepa M, van Veldhuisen DJ, Voors AA, de Boer RA. Tumour biomarkers: association with heart failure outcomes. J Intern Med. 2020 Aug;288(2):207-218. doi: 10.1111/joim.13053. Epub 2020 May 5.

  PMID: 32372544 RESULT

• Bracun V, Suthahar N, Shi C, de Wit S, Meijers WC, Klip IT, de Boer RA, Aboumsallem JP. Established Tumour Biomarkers Predict Cardiovascular Events and Mortality in the General Population. Front Cardiovasc Med. 2021 Dec 8;8:753885. doi: 10.3389/fcvm.2021.753885. eCollection 2021.

  PMID: 34957244 RESULT

• Chatzinikolaou A, Tzikas S, Lavdaniti M. Assessment of Quality of Life in Patients With Cardiovascular Disease Using the SF-36, MacNew, and EQ-5D-5L Questionnaires. Cureus. 2021 Sep 14;13(9):e17982. doi: 10.7759/cureus.17982. eCollection 2021 Sep.

  PMID: 34667665 RESULT

• Kwee LC, Neely ML, Grass E, Gregory SG, Roe MT, Ohman EM, Fox KAA, White HD, Armstrong PW, Bowsman LM, Haas JV, Duffin KL, Chan MY, Shah SH. Associations of osteopontin and NT-proBNP with circulating miRNA levels in acute coronary syndrome. Physiol Genomics. 2019 Oct 1;51(10):506-515. doi: 10.1152/physiolgenomics.00033.2019. Epub 2019 Sep 18.

  PMID: 31530226 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Stroke; Myocardial Infarction; Death; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Lyudmila Turgunova, MD, PhD, ScD

  Karaganda Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: January 30, 2023
• Study Start: June 1, 2014
• Primary Completion: March 1, 2020
• Study Completion: December 1, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share