Acute Aortic DissectionBBDRSAADNCT05206032
Blood Biomarker Discovery by Raman Spectroscopy in Acute Aortic Dissection
An observational study of Acute Aortic Dissection, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Aortic Dissection
- What is being tested?
- Raman spectroscopy
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: The study population will be recruited from the clinics at the first affiliated hospital of xi 'an jiaotong university(China).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian JiaotongUniversity
Xi'an, Shaanxi, 710061
Zhanqin Zhang, PHD, 0086-13259983110, zhanqin_zhang@xjtufh.edu.cn
About this study
Official title: Characterization of the Blood Signature as a Potential Tool for the Fast Diagnosis of of Acute Aortic Dissection
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.
Read the detailed 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).
- Conditions
- Acute Aortic Dissection
- Being tested
- Raman spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raman spectroscopyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| healthy participants | healthy participants Receives: Other: Raman spectroscopy | |
| acute aortic dissection (AAD) | acute aortic dissection (AAD) Receives: Other: Raman spectroscopy | |
| acute myocardial infarction (AMI) | acute myocardial infarction (AMI) Receives: Other: Raman spectroscopy | |
| pulmonary embolism (PE) | pulmonary embolism (PE) Receives: Other: Raman spectroscopy | |
| angina | angina Receives: Other: Raman spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start1 Dec 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Aortic DissectionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhanqin Zhang, PHD, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206032
- Sponsor's protocol ID
- 2020ZXKT35
- Acronym
- BBDRSAAD
- Status last verified
- Dec 2021
- First submitted
- 7 Dec 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Blood Signature as a Potential Tool for the Fast Diagnosis of of Acute Aortic Dissection
- ClinicalTrials.gov ID
- NCT05206032
- Acronym / sponsor ID
- BBDRSAAD / 2020ZXKT35
- Conditions
- Acute Aortic Dissection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| healthy participants | – | Other: Raman spectroscopyhealthy participants |
| acute aortic dissection (AAD) | – | Other: Raman spectroscopyacute aortic dissection (AAD) |
| acute myocardial infarction (AMI) | – | Other: Raman spectroscopyacute myocardial infarction (AMI) |
| pulmonary embolism (PE) | – | Other: Raman spectroscopypulmonary embolism (PE) |
| angina | – | Other: Raman spectroscopyangina |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will be recruited from the clinics at the first affiliated hospital of xi 'an jiaotong university(China).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raman spectroscopyBlood (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. | Other | acute aortic dissection (AAD), acute myocardial infarction (AMI), angina, healthy participants, pulmonary embolism (PE) |
Primary outcome
Identification and characterization of a new AAD blood signature through Raman spectroscopy
Time frame: One day
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.
Correlation with the clinical characteristics
Time frame: One Day
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.
Portable Raman as point of care
Time frame: One Year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhanqin Zhang, PHD study chair
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Aortic Dissection, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhanqin Zhang, PHD (0086-13259983110, zhanqin_zhang@xjtufh.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification and characterization of a new AAD blood signature through Raman spectroscopy (time frame: One day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.