ST Segment Elevation Myocardial Infarction
Conditions
Keywords
radial artery occlusion, primary percutaneous coronary intervention, distal radial access, conventional transradial access
Brief summary
Randomized-controlled trial to compare early radial artery occlusion via distal vs. conventional transradial access among ST segment elevation myocardial infarction patients for primary percutaneous coronary intervention.
Detailed description
Conventional transradial access (TRA) is recommended as the default approach for patients undergoing percutaneous coronary intervention (PCI) according to 2018 ESC guidelines. However, radial artery occlusion (RAO) remains the frequent complication, precluding the future use of the radial artery as an access point for repeat coronary recanalization or as a conduit for coronary artery bypass surgery. More than 50% of patients with ST segment elevation myocardial infarction (STEMI) present multiple vascular lesions, of which 50% require reprocessing non-culprit vessels. Therefore, the patency of the radial artery is crucial for STEMI patients. The distal radial access (DRA), located in the anatomical snuffbox or the dorsum of the hand, was introduced as a promising alternative. Three recent RCTs have shown significant reductions of RAO after DRA compared with TRA. Nevertheless, all of them excluded the patients presenting with STEMI. Therefore, we conduct a prospective, single-center, open-label randomized clinical trial to assess the superiority of preventing RAO at 24 h via DRA when compared TRA among STEMI patients for primary PCI.
Interventions
PROCEDUREdistal radial access
primary percutaneous coronary intervention via distal radial access
PROCEDUREconventional transradial access
primary percutaneous coronary intervention via conventional transradial access
Sponsors
Beijing Luhe Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Single-center, open-label, parallel randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * ST-segment elevation myocardial infarction for primary percuteous coronary intervention * Palpable pulses on both access sites of the radial artery * Informed consent
Exclusion criteria
* Thrombolysis before primary percutaneous coronary intervention * Previous CABG or radio-cephalic fistula using radial artery * Cardiogenic shock * Severe arrhythmias * Severe liver and kidney dysfunction * Pregnancy * Enrolment in another study within 1 month * Inability to obtain written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| radial artery occlusion | at 24 hours after procedure | The radial artery occlusion will be evaluated 24 hours after procedure by ultrasound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| puncture time | Immediately post-procedurally | The puncture time was defined as the time interval between local anesthesia induction and successful sheath insertion. |
| first medical contact to device (FMC2D) time | Immediately post-procedurally | FMC2D time was defined as the time interval between the patient's initial contact with the first physician who made the diagnosis and the first angioplasty balloon inflation. |
| procedural time | Immediately post-procedurally | Procedural time defined as the time interval between local anesthesia to sheath removal. |
| hemostasis time | at 24 hours after procedure | Hemostasis time was defined as the time between sheath removal to complete hemostasis. |
| the rate of successful puncture | Immediately post-procedurally | Successful puncture occurs when an introducer sheath can be properly placed through the punctured artery. |
| hand function | 1 week after procedure | Hand function was evaluated by QuickDASH questionnaire. |
| radial artery occlusion | 30days after procedure | The radial artery occlusion will be evaluated 1 month after procedure by ultrasound. |
| radial aretry injury | Immediately post-procedurally | Radial aretry injury including intimal tears, dissections, perforation and thrombosis was detected by optical coherence tomography. |
| major adverse cardiovascular events(MACE) | 30 days after procedure | MACE was defined as all-cause death, any myocardial infarction, stroke and major bleeding. |
| access-related complications | at 24 hours after procedure | Access-related complications include AV fistula formation, pseudoaneurysm, and local haematoma. |
Countries
China
Outcome results
None listed