I25
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: age over 18 years old, qualified for coronary angiography or angioplasty, scheduled or emergency surgery
Exclusion criteria
Exclusion criteria: under 18 years of age, lack of consent to participate in the study, history of upper limb trauma or forearm deformation, occlusion of forearm arteries, lack of a perceptible pulse over RA or UA, cardiogenic shock, hemodialysis therapy, CABG (coronary artery bypass graft surgery) with bilateral left internal mammary artery (LIMA) or right internal mammary artery (RIMA) or forearm arteries
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observation In-hospital observation and 30-day follow-up from the date of discharge will record the following complications: • occurrence of ischemic brain stroke or TIA (Transient Ischemic Attack) after procedure during hospitalization, • occurrence of ischemic brain stroke or TIA (Transient Ischemic Attack) in 30-day follow-up, • occurrence of arterial occlusion (used for vascular access) during hospitalization and 30-day follow-up (based on ultrasound examination), • arterial dissection or perforation (based on postoperative angiography), • pseudoaneurysm (based on ultrasound examination), • arteriovenous fistula (based on ultrasound examination), • hematoma (classification of hematoma based on EASY scale), and • major bleeding (decrease in hemoglobin by > 5g/dL, or >15% reduction in hematocrit or other life-threatening bleeding). Clinical observation, ultrasound examination, and grip pressure measurement will be performed on the first day after surgery and 30 days after surgery. During the 30-day follow-up visit, a control measure of the grip pressure will also be performed The primary endpoint will include: • complex endpoint, including major vascular complications in the in-hospital observation (stroke, TIA, arterial occlusion, major bleeding) • complex endpoint, including major vascular complications in 30-day follow-up (stroke, TIA, arterial occlusion, major bleeding) Secondary endpoints shall include: • time of effective cannulation, • effectiveness of cannulation (insertion of sheath passage and treatment), • total fluoroscopy duration, • amount of contrast used, • change in the hand grip pressure (kg) during hospital observation, • change in the hand grip pressure (kg) during 30-day observation, • the need to change vascular access (cross-over), • occurrence of arterial thrombosis, • occurrence of hematoma (analysis of backlog extent based on EASY scale), • occurrence of pseudoaneurysm, or • occurrence of vascular fistula. Additional analysis The c | — |
Secondary
| Measure | Time frame |
|---|---|
| • time of effective cannulation, • effectiveness of cannulation (insertion of sheath passage and treatment), • total fluoroscopy duration, • amount of contrast used, • change in the hand grip pressure (kg) during hospital observation, • change in the hand grip pressure (kg) during 30-day observation, • the need to change vascular access (cross-over), • occurrence of arterial thrombosis, • occurrence of hematoma (analysis of backlog extent based on EASY scale), • occurrence of pseudoaneurysm, or • occurrence of vascular fistula. | — |
Countries
Poland
Contacts
Cardiology Department, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland