Comparing two methods of accessing the radial artery in heart attack patients during treatment
Adverse Clinical Outcomes Associated With Conventional Versus Distal Radial Access in Patients With Acute Coronary Syndrome With ST-segment Elevation Treated by Percutaneous Coronary Intervention
This study is testing whether a new way of accessing the wrist for heart treatment is just as safe and effective as the traditional method for patients having a heart attack.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2922 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Nacional de Cardiologia Ignacio Chavez Academic / other |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT06013813 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the outcomes of conventional radial access versus distal radial access in patients experiencing ST-Elevation Myocardial Infarction (STEMI) who are undergoing Percutaneous Coronary Intervention (PCI). Participants will be randomly assigned to one of the two access methods to evaluate the incidence of major adverse cardiac events (MACE) within 30 days post-procedure. The goal is to determine if the distal radial approach is not inferior to the conventional method in terms of safety and effectiveness. The study aims to provide insights that could influence clinical practices in treating STEMI patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with STEMI who are eligible for PCI and have patent radial access.
Not a fit: Patients experiencing cardiogenic shock or those with previous coronary artery bypass grafting may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and outcomes for patients undergoing PCI for STEMI.
How similar studies have performed: While there have been studies on radial access methods, this specific comparison of distal versus conventional radial access in STEMI patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * STEMI patients underwent PCI. * Patent radial access (distal and conventional) * Patients who agree to participate in the study and sign the informed consent form. Exclusion Criteria: * Cardiogenic shock. * Previous coronary artery bypass grafting (CABG). * Absence of palpable radial pulse. * Arteriovenous fistula for hemodialysis. * Previous radial artery occlusion.
Where this trial is running
Mexico City
- Instituto Nacional de Cardiología Ignacio Chávez — Mexico City, Mexico (Recruiting)
Study contacts
- Study coordinator: Juan Carlos Plata Corona, PhD
- Email: juancarlosplatacorona3@gmail.com
- Phone: +522212187940
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.