Coronary Angiography
Conditions
Keywords
heparin, radial artery
Brief summary
This is a prospective, multi-center, superiority study of parallel design. Patients are enrolled if they are older than 18 years old, are scheduled for 5 or 6 Fr diagnostic coronary angiography and the interventional cardiologist is willing to proceed with radial access. Patients are randomized before diagnostic catheterization to receive intravenously either 100IU/Kg or 50 IU/Kg of unfractionated heparin (UFH) in a 1:1 ratio. Patients are discharged usually within 4 to 6 hours after coronary angiography. Radial artery in each patient is evaluated either in-hospital or during a subsequent visit by one physician who is blinded to the actual antithrombotic treatment given. Radial artery is considered occluded if it exhibits ultrasonographically no antegrade flow signal both at baseline and after reevaluation on a second occasion, within 30 days after the index procedure. Initially patent arteries will not be reexamined and are thought to remain permanently patent. The investigators also monitor major bleeding (defined as ≥ 5g/dL decrease in hemoglobin or ≥15% decrease in hematocrit or any life-threatening bleeding (confirmed by MRI or computed tomography) and large local hematomas of the forearm (defined as those extending beyond the forearm).
Interventions
Unfractionated heparin 50IU/Kg
DRUGHigh dose of Unfractionated Heparin
Unfractionated Heparin 100IU/Kg
Sponsors
University 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
* Older than 18 years old * Scheduled for 5 or 6 Fr diagnostic coronary angiography * The interventional cardiologist is willing to proceed with radial access * Written informed consent
Exclusion criteria
Before randomization * chronic hemodialysis * oral anticoagulation * hemodynamic instability * severe dermo-myoskeletal forearm deformities * history of CABG and bilateral use of either the internal mammary or radial artery * history of CABG and ipsilateral use of both the internal mammary and radial artery * admission for elective PCI After randomization * crossover to another arterial access site is required * ad hoc PCI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radial artery occlusion | 30 days | Radial artery occlusion as assessed by Doppler Ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Large local hematomas of the forearm | 30 days | large local hematomas of the forearm (defined as those extending beyond the forearm) |
| Major bleeding | 30 days | ≥ 5g/dL decrease in hemoglobin or ≥15% decrease in hematocrit or any life-threatening bleeding (confirmed by MRI or computed tomography) |
Countries
Greece
Outcome results
None listed