Acute Coronary Syndromes, Angioplasty, Transluminal, Percutaneous Coronary
Conditions
Keywords
Cardiac catheterization, Radiation Protection, Radial artery, Femoral artery
Brief summary
Excessive radiation received by the operator has been described as a possible drawback of the radial catheterization technique when compared with the femoral access. The study hypothesis is that the use of radial access device dedicated radioprotective TRIPTable ® (Transradial Intervention Table Protection) is not inferior to standard femoral technique and superior to standard radial technique as radioprotection strategy to the operator in patients with acute coronary syndromes acute and submitted to cardiac catheterization.
Detailed description
This study is prospective, 1:1:1 randomized, unicentric, comparative between femoral and radial radial technique with and without dedicated TRIPTable ® device. The TripTable device is a polycarbonate support table anatomically-designed to facilitate the radial technique, facilitating the puncturing, positioning, support to work material and providing further radioprotection from a lead layer without obstruction in viewing the fluoroscopic images.
Interventions
DEVICERadial
Standard radial artery catheterization procedure, performed for the purpose of coronary angiography and ad hoc angioplasty if necessary.
DEVICETripTable
Details of the device previously described, designed to medical operator radioprotection. No changes in radial technique beyond the use of the supportive device will be performed.
DEVICEFemoral
Standard femoral artery catheterization procedure, performed for the purpose of coronary angiography and ad hoc angioplasty if necessary. The supporting device will be the patient's own body, placing the material above the legs.
Sponsors
Marilia Medicine School
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Unstable angina with an indication for invasive stratification * Acute coronary syndrome without ST-segment elevation * Acute coronary syndrome with ST-segment elevation * Patient informed of the nature of the study and have signed the Informed Consent * Patient suitable for coronary angiography and / or percutaneous coronary intervention either by radial access as the femoral
Exclusion criteria
* Below 18 years of age * Pregnancy * Chronic use of vitamin K antagonists, or direct thrombin inhibitors or antagonists of factor Xa, * Active bleeding or high risk of bleeding (severe hepatic insufficiency, active peptic ulcer disease, creatinine clearance \<30 mL / min, platelet count \<100,000 mm3); * Uncontrolled hypertension; * Cardiogenic shock; * Previous coronary artery bypass graft surgery with the use of ≥ 1 graft * Patients not candidates for the use of any of the specified vascular access * Concomitant severe disease with life expectancy less than 12 months life; * Medical, geographical, or social conditions that impede study participation * Refusal or inability to understand and sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation dose | 1 year | Accumulated radiation dose received by the operator during the interventional cardiology procedures as measured by Thermoluminescent Dosimeters (TLD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation according measured site | 1 year | accumulated radiation dose received by each measured site (gonadal, thyroid and lens) |
| Operator absorbed radiation according total radiation dose | 1 year | Evaluation of radiation dose to the operator according to linear correlation corrected for total dose of radiation. |
| Success of procedure | 1 year | Success rate of the procedure, as defined by perform the procedure without need to cross between techniques |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical data | 1 year | Registration of clinical features and procedural data, to compare with historical control group (ARISE trial - NCT01653587) using similar inclusion criteria without the objectives of the current study operator (to exclude Hawthorne effect). |
Countries
Brazil
Outcome results
None listed