Blood Biomarker Discovery by Raman Spectroscopy in Acute Aortic Dissection

NCT05206032 | Unknown

• 1 other identifier: 2020ZXKT35
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to collect about 500 cases of blood samples from acute aortic dissection (AAD) and other acute chest pain diseases (eg, AMI, PE, or angina).The investigators tend to detect Raman metabolic profile of blood samples collected from AAD and other control groups using the Raman spectroscopy. The data collected will be analyzed and used to create a Raman database able to provide a classification model based on machine learning. The investigators then compared them with healthy participants to evaluate the diagnostic performance of different levels of Raman metabolic profile at discriminating AAD from other diagnoses and assess whether Raman metabolic profile is a potential novel biomarker for AAD under different circumstances.

Conditions

Acute Aortic Dissection

Outcome Measures

Primary Outcomes (3)

• Identification and characterization of a new AAD blood signature through Raman spectroscopy

  The Raman analysis of blood samples collected from AAD patients and other control groups, will be used to characterize a AAD signature able to discriminate subjects from other chest pain individuals.

  One day

• Correlation with the clinical characteristics

  Raman data related to subjects with AAD will be correlated with the clinical data, validating in this way our methodology. The principal correlation will be carried out between the D-Dimer and B type urine natriuretic peptide（BNP） concentrations and Raman signature.

  One Day

• Portable Raman as point of care

  The characterized and implemented classification model will be translated to a portable Raman equipped with a laser emitting at 532 nm and with a spectral resolution comparable with the one of the bench Raman. This station will be firstly tested with patients coming to the hospital and then applied continuously implementing the classification model with new Raman spectra and clinical data. In this way the investigators will highly implement the accuracy, sensitivity, precision and specificity of the model.

  One Year

Study Arms (5)

healthy participants

healthy participants

Other: Raman spectroscopy

acute aortic dissection (AAD)

acute aortic dissection (AAD)

Other: Raman spectroscopy

acute myocardial infarction (AMI)

acute myocardial infarction (AMI)

Other: Raman spectroscopy

pulmonary embolism (PE)

pulmonary embolism (PE)

Other: Raman spectroscopy

angina

angina

Other: Raman spectroscopy

Interventions

Raman spectroscopy OTHER

Blood (serum or plasma) will be collected, processed and analysed through Raman spectroscopy. Data acquired will be normalized and treated for the creation of the classification model.

acute aortic dissection (AAD); acute myocardial infarction (AMI); angina; healthy participants; pulmonary embolism (PE)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be recruited from the clinics at the first affiliated hospital of xi 'an jiaotong university(China).

You may qualify if:

• Clinical diagnosis of AAD; Clinical diagnosis of AMI; Clinical diagnosis of PE; Clinical diagnosis of angina; Healthy participants; Provided written consent for the blood samples analysis; Age between 18 and 90 years.

You may not qualify if:

• Transfusion history (packed red blood cells, whole blood, or platelets) 10 days before the blood sample was taken; Aortic trauma; Pseudo aneurysm; History of heart failure; Renal dysfunction; Severe pulmonary diseases; Active cancer; Checkup after surgery.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian JiaotongUniversity

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Interventions

Spectrum Analysis, Raman

Intervention Hierarchy (Ancestors)

Scattering, Radiation; Chemistry Techniques, Analytical; Investigative Techniques; Spectrum Analysis

Study Officials

• Zhanqin Zhang, PHD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Zhanqin Zhang, PHD

CONTACT

0086-13259983110; zhanqin_zhang@xjtufh.edu.cn

Study Design

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

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 25, 2022
• Study Start: December 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 25, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)