Cardiovascular Risk Stratification on the Basis of Surface Enhanced Raman Spectroscopy
Launched by SAMARA STATE MEDICAL UNIVERSITY · May 1, 2024
Trial Information
Current as of August 21, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new method to help identify individuals at risk for heart diseases, specifically coronary atherosclerosis, which is a condition where arteries become narrowed due to plaque buildup. The research uses advanced technology called Surface Enhanced Raman Spectroscopy (SERS) to analyze blood samples and gather more detailed information about substances in the blood that could indicate heart disease. The goal is to improve how we assess cardiovascular risk, making it easier for doctors to spot potential problems before they become serious.
To participate in this study, individuals must be between 30 and 65 years old and have had a specific heart scan called MSCT within the last year. They should not have a confirmed diagnosis of coronary heart disease but may have some related conditions, such as mild hypertension or type 2 diabetes that doesn't require insulin. Participants will undergo additional testing using this new technology, which could lead to better heart health assessments in the future. It’s important to note that people with certain heart conditions, serious illnesses, or specific risk factors, such as high cholesterol or severe obesity, cannot join the trial.
Gender
ALL
Eligibility 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.
About Samara State Medical University
Samara State Medical University is a distinguished institution dedicated to advancing medical education, research, and healthcare innovation. With a commitment to excellence, the university plays a pivotal role in clinical research, fostering collaborations that enhance patient care and contribute to the scientific community. Its state-of-the-art facilities and a team of experienced professionals ensure the highest standards in clinical trial management and execution, making it a trusted sponsor for studies aimed at improving health outcomes and addressing pressing medical challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Samara, Samara Region, Russian Federation
Patients applied
Trial Officials
Petr A Lebedev, professor
Principal Investigator
chief of therapy chair of professional education department
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported