Ignite Creation Date:
2024-05-06 @ 2:37 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04375319
Status:
UNKNOWN
Last Update Posted:
2020-05-05
First Post:
2020-04-22
Brief Title:
OCT Evaluation of Early Vascular Repair in Patients With Non ST Elevation Acute Coronary Syndrome NSTE-ACS
Sponsor:
Xuzhou Third Peoples Hospital
Organization:
Xuzhou Third Peoples Hospital
Study Overview
Official Title:
OCT Evaluation of Early Vascular Repair in Patients With Non ST Elevation Acute Coronary Syndrome NSTE-ACS
Status:
UNKNOWN
Status Verified Date:
2020-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXPECT
Brief Summary:
This is a prospective study of a new generation of drug-eluting stent in the treatment of non ST elevation acute coronary syndrome NSTE-ACS The purpose of this study was to evaluate the extent of early vascular repair in NSTE-ACS patients after receiving the new generation of drug-eluting stents and the value of OCT guided optimal implantation in further improving the target vascular endothelial repair so as to provide the basis for early discontinuation of dual antiplatelet drugs dapt in NSTE-ACS patients and later large-scale randomized clinical researchThis study is a prospective multicenter randomized controlled clinical study Sixty patients with non ST elevation acute coronary syndrome NSTE-ACS including unstable angina and acute non ST elevation myocardial infarction were enrolled in this study After obtaining the written consent of the patients the computer-generated random sequence table was randomly divided into three-month follow-up group O3 group n 20 three-month follow-up group A3 group n 20 and six-month follow-up group A6 group n 20 Among them the OCT guidance group needs to optimize the operation according to the examination results before and after the operation while the contrast guidance group only conducts OCT examination collection after the operation During the study period all patients were given dual antiplatelet therapy aspirin 100mg D clopidogrel 75mg QD or tegrilol 90mg bid Sixty patients were followed up at 30 days 3 months 6 months and 1 year after stent implantation and OCT was performed at 3 or 6 months after stent implantation with the coverage rate of neointima as the main observation index In this experiment the independent OCT imaging laboratory data management and Statistics Center clinical endpoint determination Committee and clinical supervision organization collected sorted statistically analyzed and determined all relevant clinical and OCT imaging data All the selected patients were followed up continuously within one year telephone or outpatient follow-up to observe the occurrence of adverse eventsPrimary end point stent endometrial coverage measured by OCT
Detailed Description:
This study is a prospective randomized controlled clinical trial which will adopt the central randomized method based on computer system When a patient signs the informed consent form and meets the inclusion criteria of the trial and there is no exclusion criteria for randomization the researcher fills in the randomization application form and carries out randomization by landing on the randomization website randomization system The computer system will automatically assign the randomization number and the corresponding treatment group according to the patients situation After obtaining the randomization results the researcher should be in the randomization application form and the original The random number was recorded on the case and the patients were treated according to the group Trial control assigned by the system
The trial was carried out according to the following procedures 1 signing informed consent 2 case screening 3 case selection 4 The baseline OCT imaging was completed in the O3 group including preoperative intraoperative and postoperative use and only OCT examination was performed in the A3 and A6 groups not used to guide the optimization of PCI operation 5 Follow up evaluation ① OCT follow-up was conducted 3 or 6 months after the operation and the imaging results were sent to the medical imaging analysis department for qualitative and quantitative evaluation and analysis ② outpatient or telephone follow-up was conducted 1 3 6 and 12 months after the operation and cardiovascular clinical events were recorded The results of optical coherence tomography OCT in this study were evaluated by medical imaging analysis department According to the standard procedure the results of OCT imaging after stent implantation 3 or 6 months after operation and any unexpected results are sent to the medical imaging analysis department and the qualitative and quantitative evaluation analysis are completed by experienced image analysts When the medical imaging analysis department evaluates the imaging results it does not know whether the patients come from the experimental group or the control group that is they are always in a blind state All calculation results were unblinded at the same time when the main end point data of the test were completed
The task of data management and statistical analysis of this experiment will be undertaken by clinical research center of cardiovascular medicine of the third peoples Hospital of Xuzhou City and the statistical professionals will participate in the whole process of research design implementation data management and analysis and summary of test results After the completion of the study plan and case report form a statistical analysis plan will be made to complete the statistical analysis report
The case report form CRF is filled in by the investigator and each selected case must complete the CRF After the completed case report form is reviewed by the supervisor the first copy is transferred to the data administrator for data entry and management After the first copy is handed over the contents of the case report form will not be modified The data administrator uses software to compile data entry program for data entry and management In order to ensure the accuracy of the data two data entry personnel shall independently enter and proofread the data in duplicate For the questions in the case report form the data administrator will send a query to the researcher by generating a question answer form QF query form and contact the researcher through the supervisor to answer and return as soon as possible the data administrator will modify confirm and input the data according to the researchers answers and can send a QF again if necessary After the data is reviewed and confirmed to be correct the data management personnel main researchers statistical analysts implementers and audit management personnel shall jointly review the data and complete the final definition and judgment of the analysis population and then the data administrator shall lock the database Generally the locked database or file cannot be changed After the database is locked submit it to the statistical analyst for statistical analysis
During the clinical trial the investigator of the hospital where the implementer is located and the investigator of the third peoples Hospital of Xuzhou City will visit the research center regularly to ensure that all contents of the research scheme are strictly observed and the original data are checked to ensure that the content of CRF is true complete and correct
Definition of adverse event refers to any medical event unexpected disease or injury or unfortunate clinical sign that occurs to the subject user or other personnel during the period from the time when the patient agrees to participate in the study to the time when the patient no longer participates in the study whether related to the medical device under study or not
Severity of adverse events ① mild no impact on daily activities ② moderate impact on daily activities ③ severe loss of ability of daily activities
Response measures for adverse events all adverse events occurred during the study must be recorded in the adverse event table truthfully The researchers should give targeted treatment and follow-up until the symptoms disappear or stable
Serious adverse events serious adverse events refer to the events that need hospitalization treatment prolong hospitalization time disability affect work ability endanger life or death cause congenital malformation etc during the clinical trial In case of serious adverse events during the study whether related to the trial dose or not appropriate treatment measures must be taken immediately and at the same time they shall be reported to the administrative departments implementers and clinical supervisors of the main researchers the ethics committee of the clinical research responsible unit the provincial and Municipal Health and family planning committees etc by telephone or fax within 24 hours after being informed and The serious adverse event record form shall be submitted within 24 hours after learning
Statistical analysis method
Descriptive analysis composition ratio is used to describe counting data mean standard deviation maximum value and minimum value are used to describe measuring data mean standard deviation maximum value minimum value median 25th and 75th quantiles are used to describe non normal distribution data
Baseline demographic analysis when the theoretical frequency in the four grid table is less than 5 Fishers exact probability method is used group t test two groups or variance analysis multiple groups are used for the comparison of normal distribution measurement data Wilcoxon rank sum test is used for the comparison between groups
Efficacy analysis paired t-test was used for comparison in normal distribution measurement group and Wilcoxon rank sum test was used for comparison in non normal distribution measurement group After the homogeneity of variance between the two groups was tested the covariance analysis of adjusted center effect and baseline effect was used and the least mean square of dependent variable the least mean square of group and 95 confidence interval were given to test the zero hypothesis the CMH Cochran mantel Haenszel χ 2 test of adjusted center effect was used for the inter group comparison of count data
Safety evaluation according to the experimental group and the control group describe the number and proportion of normal cases before and after treatment Adverse events were described by the number and incidence of adverse events and the proportion was tested by χ 2 test or Fisher exact probability method At the same time detailed description of all adverse events in each group the specific performance degree and the relationship with the dosage
All statistical analysis will be performed at the bilateral 005 significance level Sas913 statistical software is used for statistical analysis
The trial was carried out according to the following procedures 1 signing informed consent 2 case screening 3 case selection 4 The baseline OCT imaging was completed in the O3 group including preoperative intraoperative and postoperative use and only OCT examination was performed in the A3 and A6 groups not used to guide the optimization of PCI operation 5 Follow up evaluation ① OCT follow-up was conducted 3 or 6 months after the operation and the imaging results were sent to the medical imaging analysis department for qualitative and quantitative evaluation and analysis ② outpatient or telephone follow-up was conducted 1 3 6 and 12 months after the operation and cardiovascular clinical events were recorded The results of optical coherence tomography OCT in this study were evaluated by medical imaging analysis department According to the standard procedure the results of OCT imaging after stent implantation 3 or 6 months after operation and any unexpected results are sent to the medical imaging analysis department and the qualitative and quantitative evaluation analysis are completed by experienced image analysts When the medical imaging analysis department evaluates the imaging results it does not know whether the patients come from the experimental group or the control group that is they are always in a blind state All calculation results were unblinded at the same time when the main end point data of the test were completed
The task of data management and statistical analysis of this experiment will be undertaken by clinical research center of cardiovascular medicine of the third peoples Hospital of Xuzhou City and the statistical professionals will participate in the whole process of research design implementation data management and analysis and summary of test results After the completion of the study plan and case report form a statistical analysis plan will be made to complete the statistical analysis report
The case report form CRF is filled in by the investigator and each selected case must complete the CRF After the completed case report form is reviewed by the supervisor the first copy is transferred to the data administrator for data entry and management After the first copy is handed over the contents of the case report form will not be modified The data administrator uses software to compile data entry program for data entry and management In order to ensure the accuracy of the data two data entry personnel shall independently enter and proofread the data in duplicate For the questions in the case report form the data administrator will send a query to the researcher by generating a question answer form QF query form and contact the researcher through the supervisor to answer and return as soon as possible the data administrator will modify confirm and input the data according to the researchers answers and can send a QF again if necessary After the data is reviewed and confirmed to be correct the data management personnel main researchers statistical analysts implementers and audit management personnel shall jointly review the data and complete the final definition and judgment of the analysis population and then the data administrator shall lock the database Generally the locked database or file cannot be changed After the database is locked submit it to the statistical analyst for statistical analysis
During the clinical trial the investigator of the hospital where the implementer is located and the investigator of the third peoples Hospital of Xuzhou City will visit the research center regularly to ensure that all contents of the research scheme are strictly observed and the original data are checked to ensure that the content of CRF is true complete and correct
Definition of adverse event refers to any medical event unexpected disease or injury or unfortunate clinical sign that occurs to the subject user or other personnel during the period from the time when the patient agrees to participate in the study to the time when the patient no longer participates in the study whether related to the medical device under study or not
Severity of adverse events ① mild no impact on daily activities ② moderate impact on daily activities ③ severe loss of ability of daily activities
Response measures for adverse events all adverse events occurred during the study must be recorded in the adverse event table truthfully The researchers should give targeted treatment and follow-up until the symptoms disappear or stable
Serious adverse events serious adverse events refer to the events that need hospitalization treatment prolong hospitalization time disability affect work ability endanger life or death cause congenital malformation etc during the clinical trial In case of serious adverse events during the study whether related to the trial dose or not appropriate treatment measures must be taken immediately and at the same time they shall be reported to the administrative departments implementers and clinical supervisors of the main researchers the ethics committee of the clinical research responsible unit the provincial and Municipal Health and family planning committees etc by telephone or fax within 24 hours after being informed and The serious adverse event record form shall be submitted within 24 hours after learning
Statistical analysis method
Descriptive analysis composition ratio is used to describe counting data mean standard deviation maximum value and minimum value are used to describe measuring data mean standard deviation maximum value minimum value median 25th and 75th quantiles are used to describe non normal distribution data
Baseline demographic analysis when the theoretical frequency in the four grid table is less than 5 Fishers exact probability method is used group t test two groups or variance analysis multiple groups are used for the comparison of normal distribution measurement data Wilcoxon rank sum test is used for the comparison between groups
Efficacy analysis paired t-test was used for comparison in normal distribution measurement group and Wilcoxon rank sum test was used for comparison in non normal distribution measurement group After the homogeneity of variance between the two groups was tested the covariance analysis of adjusted center effect and baseline effect was used and the least mean square of dependent variable the least mean square of group and 95 confidence interval were given to test the zero hypothesis the CMH Cochran mantel Haenszel χ 2 test of adjusted center effect was used for the inter group comparison of count data
Safety evaluation according to the experimental group and the control group describe the number and proportion of normal cases before and after treatment Adverse events were described by the number and incidence of adverse events and the proportion was tested by χ 2 test or Fisher exact probability method At the same time detailed description of all adverse events in each group the specific performance degree and the relationship with the dosage
All statistical analysis will be performed at the bilateral 005 significance level Sas913 statistical software is used for statistical analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None