Comparing two stent deployment methods during heart procedures
Efficacy of the Pressure Optimization Protocol (POP )Versus Conventional Stent Deployment Strategy During Primary Percutaneous Coronary Intervention.
This study is testing if a new way of putting in heart stents helps people having a heart attack do better than the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institute of Cardiovascular Diseases, Pakistan Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT06430892 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the Pressure Optimization Protocol (POP) compared to conventional stent deployment strategies during primary percutaneous coronary intervention (PCI) for patients experiencing acute myocardial infarction. The study will randomly assign 400 patients to either the POP or conventional group, assessing outcomes such as TIMI III flow achievement, slow flow/no-reflow incidents, and ST-segment resolution. The trial will take place in the Cath Lab at the National Institute of Cardiovascular Diseases in Pakistan over a six-month period, with blinded outcome assessments to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing primary PCI with significant coronary artery stenosis.
Not a fit: Patients with advanced heart failure, significant comorbidities, or those who have previously undergone coronary artery bypass grafting may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes in heart attack patients undergoing stent placement, reducing complications and enhancing recovery.
How similar studies have performed: Other studies have shown promising results with similar approaches to stent deployment, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 years and above. * Patients undergoing primary percutaneous coronary intervention (PCI) with stent implantation. * Presence of significant coronary artery stenosis (greater than 70% diameter reduction) confirmed by angiography. Exclusion Criteria: * Patients with Killip class IV * Patients with significant comorbidities such as end-stage renal disease or advanced liver disease which may interfere with the procedure or follow-up. * Prior history of coronary artery bypass grafting (CABG). * Refusal to give consent for study participation or procedure
Where this trial is running
Karachi, Sindh
- National institute of cardiovascular diseases — Karachi, Sindh, Pakistan (Recruiting)
Study contacts
- Principal investigator: Abdul Hakeem, Prof — National Institute of Cardiovascular Diseases, Pakistan
- Study coordinator: Abdul Hakeem, professor
- Email: abdulhakeem@gmail.com
- Phone: +923355554342
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.