Comparing manual thrombus aspiration with PCI alone for heart attack treatment
Use of Export in Primary Percutaneous Coronary Intervention, In-Hospital and Short-term Outcomes and Optimal Time of Export
This study is testing whether using a special suction technique during heart attack treatment can help patients do better compared to just the standard procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institute of Cardiovascular Diseases, Pakistan Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT05510661 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of manual thrombus aspiration using an export catheter in patients with ST-segment Elevation Myocardial Infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). It is a single-center, randomized, open-label trial that will compare outcomes between patients receiving manual aspiration followed by PCI and those receiving PCI alone. The study will assess in-hospital and short-term adverse events, the incidence of slow flow or no reflow, and the need for intracoronary drugs. Patients will be monitored for major adverse cardiac events (MACE) and complications during their hospital stay and at one-month follow-up.
Who should consider this trial
Good fit: Ideal candidates include patients presenting with symptoms of myocardial ischemia for at least 30 minutes, with definite ECG changes indicating STEMI and total occlusion of the coronary artery.
Not a fit: Patients with a history of cardiac surgery or intervention, or those with a life expectancy of less than 6 months, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved in-hospital outcomes and reduced complications for patients experiencing STEMI.
How similar studies have performed: Previous observational studies have suggested potential benefits of manual thrombus aspiration, but this specific approach is being tested in a randomized setting for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients presenting with:-Symptoms of myocardial ischemia lasting for ≥30 minutes * Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads * Chest pain \< 12 hours duration * Total occlusion (TIMI 0 flow) * Patients undergoing primary PCI * Informed consent Exclusion Criteria: * Patients with prior history of cardiac related surgery or intervention * Performance of a rescue PCI after thrombolysis * Known existence of a disease resulting in a life expectancy of less than 6 months * Killip class III, IV
Where this trial is running
Karachi, Sindh
- National Institute of Cardiovascular Diseases — Karachi, Sindh, Pakistan (Recruiting)
Study contacts
- Principal investigator: Dr Fiaza Farooq, FCPS — National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan
- Study coordinator: Dr Faiza Farooq, FCPS
- Email: drffaziz@gmail.com
- Phone: +923002426460
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.