Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430892
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-16
Brief Title:
RAPID-POP a Randomized Controlled Trial
Sponsor:
National Institute of Cardiovascular Diseases Pakistan
Organization:
National Institute of Cardiovascular Diseases Pakistan
Study Overview
Official Title:
Efficacy of the Pressure Optimization Protocol POP Versus Conventional Stent Deployment Strategy During Primary Percutaneous Coronary Intervention
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
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:
None
Brief Summary:
Efficacy of the Pressure Optimization Protocol POP versus Conventional Stent Deployment Strategy during Primary PCI An Open Label Randomized Clinical Trial The investigators will compare conventional rapid stent inflationdeflation during primary PCI with higher pressure and prolonged duration of stent deployment
Study Hypothesis The POP in stent deployment is superior to the conventional stent deployment approach with a significantly higher achievement of the TIMI III flow significantly lesser occurrence of slow flowno-reflow and significantly higher rate of ST-Segment resolution during primary PCI
Study Hypothesis The POP in stent deployment is superior to the conventional stent deployment approach with a significantly higher achievement of the TIMI III flow significantly lesser occurrence of slow flowno-reflow and significantly higher rate of ST-Segment resolution during primary PCI
Detailed Description:
Primary Objective The primary objective is to compare the rate of TIMI III flow achievement slow flowno-reflow and ST-segment resolution between POP versus conventional stent deployment strategy during Primary PCI
Secondary Objective The secondary objective is in-hospital outcome to compare the rate of major adverse cardiovascular events MACE during hospitalization between POP versus conventional stent deployment strategy during Primary PCI Material and Methods Study design An open-label randomized controlled trial RCT with blinded outcome assessment Setting Cath Lab NICVD Karachi Hyderabad and Sukkur Duration of study 6 months Stent Deployment Protocol Patients will be randomly assigned to either POP or conventional stent deployment approach groups in 11 ratio using the block randomization method
SAMPLE SIZE 400 patients will be randomized into 2 groups with 11 Concealment Allocation schema will remain accessible to the randomization and allocation team and will be communicated to the screening and recruitment team on a patient-on-patient basis
Blinding This will be an open-label study however the outcome assessment will be blinded A de-identified CD and post-PCI ECG with a unique tracking ID will be evaluated by the team of independent consultants who will be blinded to the stent placement approach and primary outcome variables ie TIMI flow slow-flowno-reflow and ST-segment resolution will be assessed
Immediately post-procedure a de-identified CD and post-PCI ECG with a unique tracking ID will be evaluated by the team of independent consultants who will be blinded to the stent placement approach and primary outcome variables ie TIMI flow slow-flowno-reflow and ST-segment resolution will be assessed All the patients will be followed at 30 days and incidence of MACE will be recorded
In order to ensure the integrity and reliability of the data all procedures and imaging assessments will be carried out by clinicians and technicians trained and standardized in the respective methodologies Moreover data will be stored in a secure electronic database with restricted access to maintain patient confidentiality and data security Regular data audits will be conducted to ensure accuracy and consistency throughout the trial
Data Analysis
Firstly patient demographics and baseline clinical characteristics will be summarized using means and standard deviations for continuous variables and frequencies with percentages for categorical variables Kaplan-Meier survival analysis will be used to determine the time-to-event data for outcomes such as target vessel failure target vessel revascularization cardiac death and myocardial infarction Log-rank tests will be employed to compare survival curves between the POP and Rapid ID groups Cox proportional hazards models will be used to compute hazard ratios HRs and their 95 confidence intervals CIs for each outcome of interest adjusting for potential confounders
For categorical outcomes chi-squared tests or Fishers exact tests will be used as appropriate Continuous outcomes will be assessed using t-tests or Mann-Whitney U tests based on data distribution Any unmatched or imbalanced variables between the two groups will be controlled using propensity score matching To address potential confounding factors and biases a sensitivity analysis will be performed
Lastly all statistical analyses will be two-tailed with a significance level set at p 005 Statistical software such as SPSS or R will be utilized for the analysis
Secondary Objective The secondary objective is in-hospital outcome to compare the rate of major adverse cardiovascular events MACE during hospitalization between POP versus conventional stent deployment strategy during Primary PCI Material and Methods Study design An open-label randomized controlled trial RCT with blinded outcome assessment Setting Cath Lab NICVD Karachi Hyderabad and Sukkur Duration of study 6 months Stent Deployment Protocol Patients will be randomly assigned to either POP or conventional stent deployment approach groups in 11 ratio using the block randomization method
SAMPLE SIZE 400 patients will be randomized into 2 groups with 11 Concealment Allocation schema will remain accessible to the randomization and allocation team and will be communicated to the screening and recruitment team on a patient-on-patient basis
Blinding This will be an open-label study however the outcome assessment will be blinded A de-identified CD and post-PCI ECG with a unique tracking ID will be evaluated by the team of independent consultants who will be blinded to the stent placement approach and primary outcome variables ie TIMI flow slow-flowno-reflow and ST-segment resolution will be assessed
Immediately post-procedure a de-identified CD and post-PCI ECG with a unique tracking ID will be evaluated by the team of independent consultants who will be blinded to the stent placement approach and primary outcome variables ie TIMI flow slow-flowno-reflow and ST-segment resolution will be assessed All the patients will be followed at 30 days and incidence of MACE will be recorded
In order to ensure the integrity and reliability of the data all procedures and imaging assessments will be carried out by clinicians and technicians trained and standardized in the respective methodologies Moreover data will be stored in a secure electronic database with restricted access to maintain patient confidentiality and data security Regular data audits will be conducted to ensure accuracy and consistency throughout the trial
Data Analysis
Firstly patient demographics and baseline clinical characteristics will be summarized using means and standard deviations for continuous variables and frequencies with percentages for categorical variables Kaplan-Meier survival analysis will be used to determine the time-to-event data for outcomes such as target vessel failure target vessel revascularization cardiac death and myocardial infarction Log-rank tests will be employed to compare survival curves between the POP and Rapid ID groups Cox proportional hazards models will be used to compute hazard ratios HRs and their 95 confidence intervals CIs for each outcome of interest adjusting for potential confounders
For categorical outcomes chi-squared tests or Fishers exact tests will be used as appropriate Continuous outcomes will be assessed using t-tests or Mann-Whitney U tests based on data distribution Any unmatched or imbalanced variables between the two groups will be controlled using propensity score matching To address potential confounding factors and biases a sensitivity analysis will be performed
Lastly all statistical analyses will be two-tailed with a significance level set at p 005 Statistical software such as SPSS or R will be utilized for the 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