Clinical trial NCT02200783: Randomized Comparison of Radiological Exposure With TRIPTable® in Patients With Acute Coronary Syndromes
Official title: Randomized Comparison of Radiological Exposure Between Radial and Femoral Technique Assessing Use of Protective Device Dedicated TRIPTable® in Patients With Acute Coronary Syndromes Undergoing Cardiac Catheterization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndromes
Angioplasty, Transluminal, Percutaneous Coronary
Keywords: Cardiac catheterization
Radiation Protection
Radial artery
Femoral artery
Lead sponsor: Marilia Medicine School
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Radiation dose
timeFrame: 1 year
Secondary outcomes:
measure: Radiation according measured site
timeFrame: 1 year
measure: Operator absorbed radiation according total radiation dose
timeFrame: 1 year
measure: Success of procedure
timeFrame: 1 year
Other outcomes:
measure: Clinical data
timeFrame: 1 year
Locations:
city: Marilia
country: Brazil
facility: Marilia School of Medicine
state: SP
Study officials:
affiliation: Marilia School of Medicine
name: Igor RC Bienert, MD
role: STUDY_DIRECTOR
References:
citation: Chambers CE, Fetterly KA, Holzer R, Lin PJ, Blankenship JC, Balter S, Laskey WK. Radiation safety program for the cardiac catheterization laboratory. Catheter Cardiovasc Interv. 2011 Mar 1;77(4):546-56. doi: 10.1002/ccd.22867. Epub 2011 Jan 19.
citation: Sciahbasi A, Romagnoli E, Trani C, Burzotta F, Sarandrea A, Summaria F, Patrizi R, Rao S, Lioy E. Operator radiation exposure during percutaneous coronary procedures through the left or right radial approach: the TALENT dosimetric substudy. Circ Cardiovasc Interv. 2011 Jun;4(3):226-31. doi: 10.1161/CIRCINTERVENTIONS.111.961185. Epub 2011 May 17.
citation: Sciahbasi A, Calabro P, Sarandrea A, Rigattieri S, Tomassini F, Sardella G, Zavalloni D, Cortese B, Limbruno U, Tebaldi M, Gagnor A, Rubartelli P, Zingarelli A, Valgimigli M. Randomized comparison of operator radiation exposure comparing transradial and transfemoral approach for percutaneous coronary procedures: rationale and design of the minimizing adverse haemorrhagic events by TRansradial access site and systemic implementation of angioX - RAdiation Dose study (RAD-MATRIX). Cardiovasc Revasc Med. 2014 Jun;15(4):209-13. doi: 10.1016/j.carrev.2014.03.010. Epub 2014 Mar 26.
citation: Park EY, Shroff AR, Crisco LV, Vidovich MI. A review of radiation exposures associated with radial cardiac catheterisation. EuroIntervention. 2013 Oct;9(6):745-53. doi: 10.4244/EIJV9I6A119.
citation: de Andrade PB, E Mattos LA, Tebet MA, Rinaldi FS, Esteves VC, Nogueira EF, Franca JI, de Andrade MV, Barbosa RA, Labrunie A, Abizaid AA, Sousa AG. Design and rationale of the AngioSeal versus the Radial approach In acute coronary SyndromE (ARISE) trial: a randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients. Trials. 2013 Dec 18;14:435. doi: 10.1186/1745-6215-14-435.
citation: Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4.
citation: Romagnoli E, Biondi-Zoccai G, Sciahbasi A, Politi L, Rigattieri S, Pendenza G, Summaria F, Patrizi R, Borghi A, Di Russo C, Moretti C, Agostoni P, Loschiavo P, Lioy E, Sheiban I, Sangiorgi G. Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2481-9. doi: 10.1016/j.jacc.2012.06.017. Epub 2012 Aug 1.