Coronary Artery Disease, Coronary Catheterization, Distal Transradial Artery, Percutaneous Coronary Intervention, Primary PCI, ST Elevation Myocardial Infarction, Transradial Artery
Conditions
Keywords
ST Elevation Myocardial Infarction, Coronary Artery Disease, distal transradial artery, transradial artery, coronary catheterization, percutaneous coronary intervention, primary PCI
Brief summary
Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed for undertaking percutaneous coronary angiography and interventions. The existing literature has evaluated distal transradial access (dTRA) as a feasible and safe approach, with faster hemostasis, lower rates of periprocedural complications and reduced incidence of radial artery occlusion (RAO). Aim of the present study is to compare dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri- and post-procedural characteristics.
Detailed description
Gaining vascular access is the first, mandatory step for undertaking percutaneous coronary angiography and interventions. The recent guidelines, published by European Society of Cardiology (ESC), American College of Cardiology (ACC), American Heart Association (AHA) and Society for Cardiovascular Angiography and Interventions (SCAI), propose TRA as the gold standard for acute coronary syndromes (ACS), chronic coronary syndrome (CCS) percutaneous coronary interventions (PCI). Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed. The existing literature has evaluated distal transradial access (dTRA) as a feasible and safe approach, with faster hemostasis, lower rates of periprocedural complications and reduced incidence of radial artery occlusion (RAO). Mutual point of all the previous RCTs is that excluded patients suffering from ST-elevation Myocardial Infraction (STEMI). Aim of the present study is to compare dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri- and post-procedural characteristics.
Interventions
Coronary angiography +/- percutaneous coronary intervention
Sponsors
University Hospital of Patras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years old * Indication: ST-Elevation Myocardial Infraction
Exclusion criteria
* Non-palpable radial artery * Previous CABG * Anatomical restrictions for forearm approach * Hemodynamic instability * Previous radial artery catheterization from the same arm during the last 30-days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| needle-to-wire time | Immediately post-procedurally | needle-to-wire time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radial artery occlusion using Doppler examination prior to hospital discharge | The evaluation will be performed during hospitalization for STEMI and prior discharge, typically the 4th day after PCI | Radial artery patency evaluation with Doppler ultrasound prior to hospital discharge for detecting possible occlusion after cannulation |
| Access site crossover rate | Immediately post-procedurally | Crossover rate from distal transradial artery access to other access point |
| Sheath insertion time | Immediately post-procedurally | Duration required from the beginning of puncture until sheath insertion |
| Total procedure time | Immediately post-procedurally | Total duration of coronary angiography and angioplasty |
| The time interval between the initiation of radial artery puncture and the completion of coronary angiography, until the beginning of the possible PCI | Immediately post-procedurally | The time interval between the initiation of radial artery puncture and the completion of coronary angiography, until the beginning of the possible PCI |
| Required time for coronary angiography completion, after sheath insertion | Immediately post-procedurally | Required time for coronary angiography completion, after sheath insertion |
| Required time percutaneous coronary intervention completion | Immediately post-procedurally | Required time percutaneous coronary intervention completion |
| Total fluoroscopy time | Immediately post-procedurally | Total fluoroscopy time |
| Total Dose Area Product (DAP) | Immediately post-procedurally | Total Dose Area Product (DAP) |
| Air Kerma | Immediately post-procedurally | Air Kerma |
| Hemostasis time | 3 hours | Time required for achieving hemostasis |
| Vascular complications | 24 hours | Vascular complications |
| Hematomas classification (modified EASY classification) | 24 hours | Hematomas classification using modified EASY which is compatible with dTRA |
| 30-days Clinical follow-up (on site or via telephone call) | 30 days | 30-days Clinical follow-up (on site or via telephone call) |
Countries
Belgium, Greece, Switzerland
Contacts
PRINCIPAL_INVESTIGATORGrigorios Tsigkas, MD, PhD
University Hospital of Patras
PRINCIPAL_INVESTIGATORAdel Aminian, MD, PhD
Centre Hospitalier Universitaire de Charleroi
PRINCIPAL_INVESTIGATORJuan Inglesias, MD, PhD
Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland.
Outcome results
None listed