Assessing cardiovascular risk using advanced spectroscopy techniques
Cardiovascular Risk Stratification on the Basis of Surface Enhanced Raman Spectroscopy. Assessment of Technology for Early Subclinical Detection of Coronary Heart Disease Based on Serum Metabolic Shifts .
Samara State Medical University · NCT06399328
This study is testing a new way to better understand heart disease risk by looking at blood samples from people who have had a recent heart scan.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | Samara State Medical University (other) |
| Locations | 1 site (Samara, Samara Region) |
| Trial ID | NCT06399328 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve cardiovascular risk stratification by utilizing Surface Enhanced Raman Spectroscopy (SERS) alongside multispiral computed tomography (MSCT) of coronary arteries. Participants who have undergone MSCT within the last year will be categorized based on their coronary health status, including those with and without coronary heart disease (CHD). The study will analyze the spectral characteristics of blood serum to identify metabolic profiles associated with coronary atherosclerosis. By comparing these profiles across different patient groups, the researchers hope to enhance the understanding of cardiovascular disease mechanisms and improve risk assessment methods.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 30 to 65 who have undergone MSCT of coronary arteries within the last year and do not have a verified diagnosis of coronary heart disease.
Not a fit: Patients with established coronary heart disease or those who have undergone coronary interventions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and accurate cardiovascular risk assessments for patients.
How similar studies have performed: While the use of spectroscopy in cardiovascular risk assessment is a novel approach, similar studies have shown promise in utilizing advanced imaging techniques for better diagnosis and stratification.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:men and women who underwent MSCT of coronary arteries (CA) within the last year with determination of Agatston index and coronary plaques/ stenoses from 30 to 65 years old without verified diagnosis of coronary heart disease. (220 patients). * without cardiac pain * with atypical angina pectoris. * with typical angina pectoris . * possibly with asymptomatic atherosclerosis of carotid and other peripheral arteries not subject to surgical treatment (degree of stenosis not more than 50%) Possible combination with known type 2 diabetes mellitus not requiring insulin therapy, with hypertension stages 1-2. Exclusion Criteria:-absence of MSCT CA results; poor image quality. * tachycardia, irregular heart rhythm * known at the time of inclusion: Acute Coronary Syndrom, myocardial infarction,any form of verified CHD, operated for coronary atherosclerosis (PCI) peripheral arteries (carotid, renal, leg),stroke of any kind. * established diagnosis or clinical signs of chronic heart failure. * familial hypercholesterolemia (total cholesterol 7.5 mmol/L or more), * Type 1 diabetes mellitus (DM) or type 2 DM requiring insulin therapy * Creatinine 135 µmol/L or higher; * oncologic diseases, cirrhosis , * obesity : body mass index (BMI) 35kg/m2 and above, * anemia Hemoglobin below 110g/l, * dementia disorders, * absence of informed consent.
Where this trial is running
Samara, Samara Region
- Regional Samara clinical hospital na V.D.Seredavin — Samara, Samara Region, Russian Federation (RECRUITING)
Study contacts
- Principal investigator: Petr A Lebedev, professor — chief of therapy chair of professional education department
- Study coordinator: Petr Lebedev, professor
- Email: palebedev@yahoo.com
- Phone: +7927-260-20-24
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Atherosclerosis of Native Coronary Artery, Surface Enhances Raman Spectroscopy, Computer Tomography of coronary arteries, Calcium coronary score, cardiovascular risk stratification