Randomized Comparison of JUDkins vs tiGEr Catheter in Coronary Angiography Via the Right Radial Artery: the JUDGE Study (JUDGE)

May 25, 2017 updated by: Xanthopoulou Ioanna, University Hospital of Patras
The investigators aim to assess safety and efficiency of Tiger II (5Fr; Terumo Interventional Systems, Somerset, New Jersey) vs Judkins (5Fr; 3.5L/4R, Medtronic Co) catheters, in coronary angiography via the right transradial route. This is a prospective, randomized, two-centre, study of parallel design. Consecutive patients with acute coronary syndrome (ACS), eligible for non-urgent coronary angiography, are randomized after successful cannulation of right radial artery and informed consent to either Tigger II or Judkins 3.5L/4R catheters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

From the entrance of the first diagnostic catheter into the sheath and until the completion of the diagnostic coronary angiography will be the measurement of the endpoints of the study.

In case of failure to complete the coronary angiogram with the catheter study a crossover to the other catheter of the study will take place except in cases of severe spasm, where catheter choice will be at the discretion of the operator. In case of failure of the other study's catheter, next catheter's selection will be at operator's discretion. Patients included in the study, who do not process to adhoc PCI, will be monitored with baseline creatinine and creatinine value at day 2 or 3 after coronary angiography.

In all angiography films will be conducted offline analysis by two experienced operators for scoring opacification grade and coronary ostium contact with the catheters used.

DEFINITIONS Mild spasm Spasm causing well tolerated local pain Moderate spasm Spasm which causes severe pain but the handling of catheters remains satisfactory Severe spasm Spasm that leads to change diagnostic catheter or access site Duration of coronary angiogram Is defined as the time from the insertion of the first diagnostic coronary catheter in the sheath to the exit of the last diagnostic catheter from the sheath Radiation time Radiation time from the insertion of the first diagnostic coronary catheter in the right radial sheath to the exit of the last diagnostic catheter from the sheath Dose area product (DAP) DAP from the insertion of the first diagnostic coronary catheter in the sheath to the exit of the last diagnostic catheter from the sheath Contrast volume Contrast volume (ml) used from the insertion of the first diagnostic coronary catheter in the sheath to the exit of the last diagnostic catheter from the sheath Contrast induced nephropathy (CIN) Relative increase ≥25% from baseline or absolute increase ≥ 0.5mg/dl of serum creatinine within 48-72 hours of intravenous contrast administration Opacification grade 0=poor/non-diagnostic

  1. moderate opacification only in systole or diastole
  2. moderate opacification throughout cardiac cycle
  3. complete opacification but not throughout cardiac cycle
  4. complete opacification throughout cardiac cycle Catheter contact with coronary ostium

0=none and non-diagnostic study

1=none but diagnostic study 2=non-coaxial contact 3=coaxial contact Catheter stability within the coronary ostium 0=no catheter's steady engagement of the ostium throughout the angiographic view

1=catheter's steady engagement of the ostium throughout the angiographic view Catheter failure Completion of coronary angiogram after study catheter crossover with or without right radial access site crossover Based on pilot data and previously published data we hypothesized that Tiger catheter use will lead to an absolute decrease of at least 5 ml in contrast volume compared with Judkins catheters (48 and 53 ml for Tiger και Judkins catheters respectively, with estimated standard deviation of 17 for both). With a 2-sided alpha of 0.05, group sample sizes of 316 and 316 will achieve 95% power to detect this difference.

Study Type

Interventional

Enrollment (Actual)

640

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • Second Department of Cardiology, Red Cross General Hospital
    • Achaia
      • Patras, Achaia, Greece, 26500
        • Patras University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Written informed consent
  2. Indication for non-urgent coronary angiography
  3. Successful cannulation of right radial artery
  4. Availability of both Tiger and JL3.5/JR4 catheters

Exclusion Criteria

  1. Indication for urgent coronary angiography (ST-elevation myocardial infarction or non ST-elevation myocardial infarction with indication for coronary angiogram within 2 hours)
  2. Hemodynamic instability
  3. Non palpable right coronary artery
  4. Abnormal Allen test
  5. Prior coronary artery bypass grafting
  6. Chronic kidney disease or dialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Judkins L3.5/R4 cardiac catheters
Device: Judkins 3.5L/4R cardiac catheters
Judkins 3.5L/4R cardiac catheters
Experimental: Tiger cardiac catheter
Device: Tiger cardiac catheter
Tiger cardiac catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contrast volume
Time Frame: End of coronary angiography
Contrast volume (in ml) between groups used for completion of coronary angiogram in intention to treat analysis analysis
End of coronary angiography

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contrast volume
Time Frame: End of coronary angiography
Contrast volume (in ml) between groups used for completion of coronary angiogram in per protocol analysis
End of coronary angiography
Dose Area Product (DAP)
Time Frame: End of coronary angiography
DAP (cGy*cm2) between groups in intention to treat and per protocol analysis
End of coronary angiography
Fluoroscopy time
Time Frame: End of coronary angiography
Fluoroscopy time (min) between groups in ITT and per protocol analysis
End of coronary angiography
Contrast induced nephropathy (CIN)
Time Frame: End of coronary angiography
CIN rate between groups in ITT and per protocol analysis
End of coronary angiography
Catheter failure
Time Frame: End of coronary angiography
Catheter failure rate between groups
End of coronary angiography
Severe spasm
Time Frame: End of coronary angiography
Severe spasm rate between groups
End of coronary angiography
Coronary angiogram time
Time Frame: End of coronary angiography
Duration of coronary angiogram between groups in ITT and per protocol analysis
End of coronary angiography
Opacification grade
Time Frame: End of coronary angiography
Opacification grade for LAD, LCX and RCA between study catheters
End of coronary angiography
Contact to coronary ostium
Time Frame: End of coronary angiography
Contact to left and right coronary ostium between study catheters
End of coronary angiography
Stability within the coronary ostium
Time Frame: End of coronary angiography
Catheter's steady engagement of the ostium throughout the angiographic view
End of coronary angiography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Patras

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

May 25, 2017

Study Completion (Actual)

May 25, 2017

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimate)

February 3, 2017

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUH1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe