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Comparison of Left and Right Transradial Approach for CAG and PCI (COMPARE-Rad)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03389503
Recruitment Status : Completed
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Young Jin Youn, Wonju Severance Christian Hospital

Study Description
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Brief Summary:
This trial will compare the procedural success rate between right and left radial approach in patients undergoing coronary angiography and coronary intervention.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Stable Angina Unstable Angina Non-ST Elevation Myocardial Infarction ST-segment Elevation Myocardial Infarction Ischemic Heart Disease Without Angina Procedure: Radial approach Not Applicable

Detailed Description:

The three operators who are proficient in the left radial approach for coronary angiography and coronary intervention will be assigned to the right radial approach for 3 months (phase 1). After then, these three operators will switch approach site to the left radial for another 3 months (phase 2).

Procedural success, time of the procedure, use of contrast agent, and fluoroscopic data will be compared between right radial approach (phase 1) group and left radial approach (phase 2).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 322 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 1~3 months: Right radial approach 4~6 months: Left radial approach
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison Between Left and Right Transradial Approach During Coronary Angiography and Percutaneous Coronary Intervention
Actual Study Start Date : March 8, 2017
Actual Primary Completion Date : September 7, 2017
Actual Study Completion Date : September 7, 2017
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Right radial approach
Right radial approach for coronary angiography and coronary intervention
 Procedure: Radial approach
Approach site for coronary angiography and coronary intervention
Active Comparator: Left radial approach
Left radial approach for coronary angiography and coronary intervention
 Procedure: Radial approach
Approach site for coronary angiography and coronary intervention


Outcome Measures
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Primary Outcome Measures :
  1. Procedural success [ Time Frame: At the end of procedure ]
    Finishing coronary angiography/intervention without changing approach site


Secondary Outcome Measures :
  1. Puncture time [ Time Frame: At the end of procedure ]
    Duration from the start of local anesthesia infiltration to the insertion of sheath

  2. Coronary angiography time [ Time Frame: At the end of procedure ]
    Duration from the insertion of sheath to the end of coronary angiography

  3. Puncture + Coronary angiography time [ Time Frame: At the end of procedure ]
    Sum of puncture time and coronary angiography time

  4. Coronary intervention time [ Time Frame: At the end of procedure ]
    Duration from the end of coronary angiography to the end of coronary intervention

  5. Contrast amount during coronary angiography [ Time Frame: At the end of procedure ]
    Amount of contrast agent used during coronary angiography

  6. Contrast amount during coronary intervention [ Time Frame: At the end of procedure ]
    Amount of contrast agent used during coronary intervention

  7. Fluoroscopic dose, dose area product during coronary angiography [ Time Frame: At the end of procedure ]
    Dose area product during coronary angiography

  8. Fluoroscopic dose, dose area product during coronary intervention [ Time Frame: At the end of procedure ]
    Dose area product during coronary intervention

  9. Fluoroscopic time during coronary angiography [ Time Frame: At the end of procedure ]
    Fluoroscopic time during coronary angiography

  10. Fluoroscopic time during coronary intervention [ Time Frame: At the end of procedure ]
    Fluoroscopic time during coronary intervention


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects undergoing coronary angiography via radial approach
  • Subjects undergoing coronary intervention via radial approach
  • Subjects give written informed consent

Exclusion Criteria:

  • Subjects undergoing procedure(s) other than coronary angiography or intervention
  • Subjects with contraindication of radial approach (i.e, non-palpable radial pulsation, abnormal Allen's test, known radial artery tortuosity or occlusion, arteriovenous fistula for dialysis)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389503


Locations
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Korea, Republic of
Wonju Severance Christian Hospital
Wonju, Gangwon, Korea, Republic of, 26426
Sponsors and Collaborators
Wonju Severance Christian Hospital
More Information
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Responsible Party: Young Jin Youn, Assistant professor, Wonju Severance Christian Hospital
ClinicalTrials.gov Identifier: NCT03389503    
Other Study ID Numbers: CR316096
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Young Jin Youn, Wonju Severance Christian Hospital:
Access site
Transradial access
Coronary artery disease
Learning curve
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Heart Diseases
Angina Pectoris
Angina, Stable
ST Elevation Myocardial Infarction
Angina, Unstable
Non-ST Elevated Myocardial Infarction
Infarction
 Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations