Coronary Artery Disease
Conditions
Keywords
radial artery, distal radial artery, vascular access, radial artery occlusion
Brief summary
The investigators are conducting a randomized clinical trial, having as a primary objective, to compare vascular access time between distal and proximal radial approach. Secondary objectives include comparing incidence of distal and proximal radial artery occlusion, at 24 hrs and 30 days. As a tertiary objective investigators will compare the preference of the patients for each access in subsecuent interventional procedures.
Detailed description
Randomised Clinical Trial / Equivalence Model Permutted block asignation 1:1 Statistical Power 90% and Significance 2.5%. Sample Loss estimation - 15% Chi-square to categorical and T Student to numerical variables. Logistic regression binomial for adverse outcomes. If needed, an intention to treat analysis will be performed.
Interventions
PROCEDUREDistal Radial Vascular Access
Distal Radial Vascular Access
Sponsors
Instituto Mexicano del Seguro Social
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomised Clinical Trial - Equivalence model (Two tailed) Based on a previous pilot study: SD 97 sec Allowable Diff: 90 sec, Patient loss 15%, Type I error 2.5%, Type II error 90% Mean Differences: 0
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years * Clinical indication for coronary angiography / angioplasty * Palpable radial and distal radial pulse * Previous clinical Barbeau test * Radial and distal radial patency via vascular ultrasound * 24-hour and 30-day follow-up feasibility
Exclusion criteria
* Previous vascular punctions in the studied anatomic site * Artery introductor relationship * Arteriovenous fistula * Current treatment with oral anticoagulants * Contraindication for Heparin * Incomplete medical records * Vascular access sheath - radial artery mismatch * Distal radial or ulnar fracture history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vascular Access Time | Seconds during the procedure | Starts when the anesthesia needle contacts the skin and stops when the introducer sheath has been properly placed and flushed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conventional Radial Artery Occlusion | In the first 24 hours, and follow up to 30 days | Radial Artery Occlusion using vascular ultrasound |
| Distal Radial Artery Occlusion | In the first 24 hours, and follow up to 30 days | Distal Radial Artery Occlusion using vascular ultrasound |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life outcome | 30-day survey | Patient preference for the same access in case a second procedure is needed |
Countries
Mexico
Outcome results
None listed