Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Sample Collection: Blood (serum and plasma) collection from all the selected subjects at admission will be performed following the collection tube manufacturer's instructions. Then the collected samples will be stored at -80° C. Data Collection: For the Raman analysis, 5 μL of each sample will be casted on an aluminium foil in order to achieve the Surface Enhanced Raman Scattering (SERS). Raman and SERS spectra will be acquired using a WITec Alpha500 confocal micro-Raman spectroscopy system (WITec, Germany) with a 532 nm He-Ne laser (Research Electro-Optics, Inc., USA) as the excitation source, which offered a resolution of approximately 3 cm-1. The instrument will be calibrated before each analysis using the reference band of silicon at 520.7 cm-1. A 20× microscope objective (NA = 1.25, Zeiss, Germany) was used for spectral excitation and measurements. All spectral information were recorded by a back-illuminated deep-depletion charge coupled device camera (ardorTechnology, UK) working at -60°C with a 1.5 s acquisition time for a single spectrum with a spectral range of 300-4000 cm-1. The software package WITec Project spectral analysis (WITec GmbH, Germany) will be used for map design and the acquisition of spectra. Data Processing: All the acquired spectra will be fit with a nine-order polynomial baseline and normalized by unit vector using the dedicated WITec Project spectral analysis software. The statistical analysis to validate the method, will be performed using a multivariate analysis approach. Principal Component analysis (PCA) will be performed in order to reduce data dimensions and to evidence major trends. Mann-Whitney will be performed on PCs scores to verify the differences statistically relevant between the analysed groups. Correlation and partial correlation analysis will be performed using the Spearman's test, assuming as valid correlation only the coefficients with a p-value lower than 0.05. Subsequently, principal components analysis (PCA) combined with linear discriminant analysis (LDA), PCA combined with support vector machine (SVM), partial least squares-discriminant analysis (PLS-DA) and etc were tested for evaluation of diagnostic power. The statistical analysis will be performed using Origin2018 (OriginLab, USA) and MATLAB R2018b software (Mathworks. Inc., Natica, MA, USA). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05206032
Study type Observational
Source First Affiliated Hospital Xi'an Jiaotong University
Contact Zhanqin Zhang, PHD
Phone 0086-13259983110
Email [email protected]
Status Recruiting
Phase
Start date December 1, 2021
Completion date December 31, 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05484830 - Coagulation in Acute Aortic Dissection N/A
Completed NCT02732340 - Triple-branch Stent Graft Placement for the Treatment of Acute DeBakey I Aortic Dissection N/A
Recruiting NCT04122573 - Prospective Multicenter Study for Early Evaluation of Acute Chest Pain
Recruiting NCT02622750 - Triple-branch Stent Graft Placement and Total-arch Replacement for the Treatment of Acute DeBakey I Aortic Dissection Early Phase 1
Recruiting NCT05174767 - PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I Dissection N/A
Active, not recruiting NCT03414866 - Thoraflex Hybrid Post-Market Study
Completed NCT03381716 - Correlation Between Sex and Prognosis of Acute Aortic Dissection in the Chinese Population N/A
Completed NCT05409677 - Perioperative Eosinophils Their Recovery in Type A Acute Aortic Dissection Prognosis
Active, not recruiting NCT01894334 - Mechanism and Early Intervention Research on ALI During Emergence Surgery of Acute Stanford A Aortic Dissection N/A