Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565819
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Important Parameters of NIR-II Imaging in the Early Diagnosis of Lower Extremity Peripheral Artery Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Trial of Important Parameters of NIR-II Imaging in the Diagnosis of Lower Extremity Peripheral Artery Disease in Patients With Type 2 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lower extremity peripheral artery disease PAD is a growing global health problem New ways have been explored to diagnose PAD in recent years such as the second near-infrared region NIR-II 900-1880 nm wavelengths imaging In this study NIR-II imaging was performed on patients with type 2 diabetes without PAD and time-intensity curves were generated according to the imaging results and specific parameters on the curves were analyzed The key parameters for the diagnosis of lower limb artery plaque were obtained by comparing the parameters of patients with and without plaque Patients will be followed up six months and one year after the first NIR-II imaging The patient will undergo Duplex ultrasound DUS NIR-II imaging and laboratory examination With DUS results as the reference standard patients diagnosed with PAD for the first time during follow-up were focused on and the parameter range of the first NIR-II imaging was statistically analyzed so as to obtain the diagnostic threshold for early diagnosis of PAD
Detailed Description:
1 The registry procedures and quality assurance the study recruited patients diagnosed with type 2 diabetes from the Department of Endocrinology at the Second Hospital of Shanxi Medical University If the patient meets the inclusion criteria and agrees to be enrolled a written informed consent will be signed The imaging process is completed by a uniform standard and all imaging operations are performed by the same operator The operator has been formally trained and the procedure and results are checked by another professional NIR imaging engineer
2 Imaging process The imaging device used was Full Spectrum Opening in Vivo Fluorescence Imaging System DPM-IVFM-NIR-OF Beijing Digital Precision Medicine Technology Co Ltd China Firstly participants were asked if they had a history of indocyanine green ICG or iodine allergy If there was no relevant allergy history an ICG skin test was performed on each participant The skin test reagent was the ICG solution Dandong Yichuang Pharmaceutical China with a concentration of 0005mgmL diluted with sterile water for injection The test reagent 01 ml was injected subcutaneously into the inner forearm and the subject was observed for 20 min If there was no allergic reaction an indent needle was placed in the basilic vein of patients The NIR imaging was conducted in a room without natural light Before the examination the subject rested for at least 15 min in a supine position with both knee joints bent 90 degrees and both feet put together and then step horizontally on the black background board on the examination bed In NIR-II imaging the selected filter was 1000 nm long-pass The power of the 808nm wavelength laser emitter was adjusted to 10000mW with the aperture size adjusted to 20 and the exposure time set to 100 ms The laser emitter was fixed at 20cm vertical to the dorsal foot and the NIR-II camera was fixed at 40cm vertical to the dorsal foot ICG solution 25 mgmL diluted with sterile water for injection was administered intravenously via an indignant needle The dose of ICG injected was determined according to body weight 01mgKg The time for intravenous injection of ICG solution was 5 seconds The intensity of fluorescence signal on both the dorsal feet was recorded within 5 minutes after ICG solution was injected The dorsal pedis region from the transverse tarsus joint to the distal metatarsal bone was selected as the region of interest ROI The ROI was analyzed using the built-in analysis software External Data processing to generate a time-intensity curve
3 Plan for missing data missing data will be excluded from analysis
4 Methods to summarize the data NIR-II parameters extracted from time-intensity curves for all patients were recorded in the same excell table In addition baseline information such as age gender height weight etc and clinical characteristics such as years of diabetes hypertension hyperlipidemia etc of all patients were recorded in this table
5 Statistical analysis In this study SPSS 260 software and R 420 software were used to conduct in-depth statistical research When processing measurement data the Kolmogorov-Smirnov test was first used to verify whether the data followed the normal distribution Data with a normal distribution was represented by xs while data with a skewed distribution was represented by M Q1 Q3 For comparison between groups the independent sample test or the Mann-Whitney U test were selected For classified data χ2 test or Fisher exact probability method was chosen for further investigation A significance level of P 005 means that the difference was statistically significant
2 Imaging process The imaging device used was Full Spectrum Opening in Vivo Fluorescence Imaging System DPM-IVFM-NIR-OF Beijing Digital Precision Medicine Technology Co Ltd China Firstly participants were asked if they had a history of indocyanine green ICG or iodine allergy If there was no relevant allergy history an ICG skin test was performed on each participant The skin test reagent was the ICG solution Dandong Yichuang Pharmaceutical China with a concentration of 0005mgmL diluted with sterile water for injection The test reagent 01 ml was injected subcutaneously into the inner forearm and the subject was observed for 20 min If there was no allergic reaction an indent needle was placed in the basilic vein of patients The NIR imaging was conducted in a room without natural light Before the examination the subject rested for at least 15 min in a supine position with both knee joints bent 90 degrees and both feet put together and then step horizontally on the black background board on the examination bed In NIR-II imaging the selected filter was 1000 nm long-pass The power of the 808nm wavelength laser emitter was adjusted to 10000mW with the aperture size adjusted to 20 and the exposure time set to 100 ms The laser emitter was fixed at 20cm vertical to the dorsal foot and the NIR-II camera was fixed at 40cm vertical to the dorsal foot ICG solution 25 mgmL diluted with sterile water for injection was administered intravenously via an indignant needle The dose of ICG injected was determined according to body weight 01mgKg The time for intravenous injection of ICG solution was 5 seconds The intensity of fluorescence signal on both the dorsal feet was recorded within 5 minutes after ICG solution was injected The dorsal pedis region from the transverse tarsus joint to the distal metatarsal bone was selected as the region of interest ROI The ROI was analyzed using the built-in analysis software External Data processing to generate a time-intensity curve
3 Plan for missing data missing data will be excluded from analysis
4 Methods to summarize the data NIR-II parameters extracted from time-intensity curves for all patients were recorded in the same excell table In addition baseline information such as age gender height weight etc and clinical characteristics such as years of diabetes hypertension hyperlipidemia etc of all patients were recorded in this table
5 Statistical analysis In this study SPSS 260 software and R 420 software were used to conduct in-depth statistical research When processing measurement data the Kolmogorov-Smirnov test was first used to verify whether the data followed the normal distribution Data with a normal distribution was represented by xs while data with a skewed distribution was represented by M Q1 Q3 For comparison between groups the independent sample test or the Mann-Whitney U test were selected For classified data χ2 test or Fisher exact probability method was chosen for further investigation A significance level of P 005 means that the difference was statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None