Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06430892 |
| Other study ID # |
IRB-23/2024 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2024 |
| Est. completion date |
November 2024 |
Study information
| Verified date |
May 2024 |
| Source |
National Institute of Cardiovascular Diseases, Pakistan |
| Contact |
Abdul Hakeem, professor |
| Phone |
+923355554342 |
| Email |
abdulhakeem[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 inflation/deflation 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 flow/no-reflow, and significantly higher rate of
ST-Segment resolution during primary PCI.
Description:
Primary Objective The primary objective is to compare the rate of TIMI III flow achievement,
slow flow/no-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 1:1 ratio using the block randomization method.
SAMPLE SIZE : 400 patients will be randomized into 2 groups with 1:1 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 i.e. TIMI flow, slow-flow/no-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 i.e. TIMI flow, slow-flow/no-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 I/D 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 Fisher's 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 <
0.05. Statistical software such as SPSS or R will be utilized for the analysis.
