Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06430892
Study type Interventional
Source National Institute of Cardiovascular Diseases, Pakistan
Contact Abdul Hakeem, professor
Phone +923355554342
Email abdulhakeem@gmail.com
Status Recruiting
Phase N/A
Start date May 15, 2024
Completion date November 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05759078 - Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion Phase 4
Completed NCT06408636 - Prognostic Role of LA Strain in Acute Myocardial Infarction
Recruiting NCT06038994 - Prognostic Value of Surem TRAF3IP2 Level in Patients With Acute Myocardial Infarction
Recruiting NCT04968808 - Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI) N/A
Completed NCT03338504 - Determining the Mechanism of Myocardial Injury and Role of Coronary Disease in Type 2 Myocardial Infarction
Recruiting NCT03317691 - The ALERT-Pilot Study N/A
Active, not recruiting NCT05077683 - Direct Oral Anticoagulants for Prevention of lEft ventRIcular Thrombus After Anterior Acute Myocardial InFarction - APERITIF Phase 3
Recruiting NCT03957005 - Cardiovascular Risk Assessment Model in Patients With MI
Enrolling by invitation NCT05955950 - Gratitude Intervention in Promoting Self-care in Patients With Myocardial Infarction N/A
Active, not recruiting NCT06141252 - Benefit of Hypothermia in OHCA Complicating AMI N/A
Not yet recruiting NCT04560023 - Effectiveness of Multimedia Exposure in Patients Transferred to Hospital Suffering From Acute Myocardial Infarction N/A
Terminated NCT03809689 - Study of Cardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET N/A
Completed NCT05118009 - Artificial Intelligence Based Rapid Identification of ST-elevation Myocardial Infarction Using Electrocardiogram (ARISE) N/A
Active, not recruiting NCT04753749 - Evaluation of a Modified Anti-Platelet Therapy Associated With Low-dose DES Firehawk in Acute Myocardial Infarction Patients Treated With Complete Revascularization Strategy N/A
Completed NCT04769219 - Secondary Prevention Education After Acute Myocardial Infarction N/A
Active, not recruiting NCT05350969 - Study to Assess Efficacy and Safety of CDR132L in Patients With Reduced Left Ventricular Ejection Fraction After Myocardial Infarction Phase 2
Recruiting NCT05999110 - Algarve Active Ageing - Cardiac and Osteoarthritis Rehabilitation (A3-COR) N/A
Completed NCT04167904 - Biomarkers in Patients Hospitalized With Suspected Acute Myocardial Infarction
Not yet recruiting NCT04989777 - IABP In AMI Patients With SCAI-B Study N/A
Recruiting NCT05043610 - MSCs for Prevention of MI-induced HF Phase 3