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Randomized Comparison of Radiological Exposure With TRIPTable® in Patients With Acute Coronary Syndromes (TRIPTABLE)

Primary Purpose

Acute Coronary Syndromes, Angioplasty, Transluminal, Percutaneous Coronary

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

TripTable

Radial

Femoral

About this trial

This is an interventional treatment trial for Acute Coronary Syndromes focused on measuring Cardiac catheterization, Radiation Protection, Radial artery, Femoral artery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Marilia School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Radial

Femoral

TripTable

Arm Description

Cardiac catheterization and coronary angioplasty performed via standard radial artery technique.

Cardiac catheterization and coronary angioplasty performed via standard femoral artery technique.

Cardiac catheterization and coronary angioplasty performed with standard transradial technique plus using the TRIPTable device.

Outcomes

Primary Outcome Measures

Radiation dose

Accumulated radiation dose received by the operator during the interventional cardiology procedures as measured by Thermoluminescent Dosimeters (TLD)

Secondary Outcome Measures

Radiation according measured site

accumulated radiation dose received by each measured site (gonadal, thyroid and lens)

Operator absorbed radiation according total radiation dose

Evaluation of radiation dose to the operator according to linear correlation corrected for total dose of radiation.

Success of procedure

Success rate of the procedure, as defined by perform the procedure without need to cross between techniques

Full Information

NCT ID

NCT02200783

First Posted

July 23, 2014

Last Updated

July 21, 2015

Sponsor

Marilia Medicine School

1. Study Identification

Unique Protocol Identification Number

NCT02200783

Brief Title

Randomized Comparison of Radiological Exposure With TRIPTable® in Patients With Acute Coronary Syndromes

Acronym

TRIPTABLE

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

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

July 2014 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Marilia Medicine School

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndromes, Angioplasty, Transluminal, Percutaneous Coronary

Keywords

Cardiac catheterization, Radiation Protection, Radial artery, Femoral artery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radial

Arm Type

Active Comparator

Arm Description

Cardiac catheterization and coronary angioplasty performed via standard radial artery technique.

Arm Title

Femoral

Arm Type

Active Comparator

Arm Description

Cardiac catheterization and coronary angioplasty performed via standard femoral artery technique.

Arm Title

TripTable

Arm Type

Experimental

Arm Description

Cardiac catheterization and coronary angioplasty performed with standard transradial technique plus using the TRIPTable device.

Intervention Type

Device

Intervention Name(s)

TripTable

Other Intervention Name(s)

TRansradial Intervention Protection Table

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Radial

Other Intervention Name(s)

PHILIPS standard cath arm support - NCVA097

Intervention Description

Standard radial artery catheterization procedure, performed for the purpose of coronary angiography and ad hoc angioplasty if necessary.

Intervention Type

Device

Intervention Name(s)

Femoral

Intervention Description

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.

Primary Outcome Measure Information:

Title

Radiation dose

Description

Accumulated radiation dose received by the operator during the interventional cardiology procedures as measured by Thermoluminescent Dosimeters (TLD)

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Radiation according measured site

Description

accumulated radiation dose received by each measured site (gonadal, thyroid and lens)

Time Frame

1 year

Title

Operator absorbed radiation according total radiation dose

Description

Evaluation of radiation dose to the operator according to linear correlation corrected for total dose of radiation.

Time Frame

1 year

Title

Success of procedure

Description

Success rate of the procedure, as defined by perform the procedure without need to cross between techniques

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

Clinical data

Description

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).

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Igor RC Bienert, MD

Organizational Affiliation

Marilia School of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Marilia School of Medicine

City

Marilia

State/Province

ZIP/Postal Code

17514410

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

21254324

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.

Results Reference

background

PubMed Identifier

21586692

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.

Results Reference

background

PubMed Identifier

24746599

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.

Results Reference

background

PubMed Identifier

24169135

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.

Results Reference

background

PubMed Identifier

24345099

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.

Results Reference

result

PubMed Identifier

21470671

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. Erratum In: Lancet. 2011 Apr 23;377(9775):1408. Lancet. 2011 Jul 2;378(9785):30.

Results Reference

result

PubMed Identifier

22858390

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.

Results Reference

result

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Randomized Comparison of Radiological Exposure With TRIPTable® in Patients With Acute Coronary Syndromes

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