Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy (L-RECORD)

June 3, 2018 updated by: Tsigkas Grigorios, University Hospital of Patras
This randomized, multicenter, prospective study seeks to compare left radial and femoral access during cardiac catheterization of patients with prior history of CABG surgery, with the primary objective of demonstrating that the two access techniques do not differ in the net procedure time (non-inferiority study) expanding the documented benefits of radial access to this group of patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients from 4 different centers with a history of CABG are randomized 1:1 to left radial or femoral access. Based on the literature, a randomized study sample of a total of 150 patients was calculated with assumptions of 30 +/- 10-minute duration of the procedure, alpha = 5%, beta = 10% (power 90%) and non-inferiority limit Δ = 5 minutes. The primary endpoint of the study is the time it takes after placing the sheath at the initial puncture site until the completion of the diagnostic procedure (Net procedure time). Secondary endpoints include total time of the procedure, fluoroscopy time, total patient exposure radiation, amount of contrast used, possible vascular complications, major cardiovascular events and need for crossover access site.

Study Type

Interventional

Enrollment (Actual)

150

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
    • Achaia
      • Patras, Achaia, Greece, 26504
        • University Hospital of Patras

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age over 18 years
  2. Written informed consent
  3. Clinical indication for coronary angiography in a patient with prior history of CABG
  4. Left radial artery has not been used as a graft during CABG

Exclusion Criteria:

  1. Age over 90 years
  2. Patient's refusal to participate in the study
  3. Hemodynamic instability of the patient
  4. Failure to place a sheath at the randomization access site
  5. Arteriovenous fistula at the left upper limb
  6. Use of right internal mammary artery as a graft during CABG
  7. Creatinine clearance <30 ml/min

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: Left Radial access
Left Radial approach for coronary angiography in patients with prior history of CABG surgery
Procedure: Coronary Angiography
Comparison of left radial versus femoral access during coronary angiography of patients who have undergone coronary artery bypass grafting surgery
Active Comparator: Femoral access
Femoral approach for coronary angiography in patients with prior history of CABG surgery
Procedure: Coronary Angiography
Comparison of left radial versus femoral access during coronary angiography of patients who have undergone coronary artery bypass grafting surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Net Procedure Time
Time Frame: 24 hours
The time (min) after placement of the sheath at the initial puncture site until the completion of the diagnostic coronary angiography
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Procedure Time
Time Frame: 24 hours
The time (min) from local anesthesia at the access site until the completion of the diagnostic coronary angiography
24 hours
Fluoroscopy Time
Time Frame: 24 hours
Radiation time (min) after placing the sheath at the initial puncture site until the completion of the diagnostic coronary angiography
24 hours
Dose Area Product
Time Frame: 24 hours
Radiation DAP (mGy*cm2) during the diagnostic coronary angiography
24 hours
Contrast Volume
Time Frame: 24 hours
Contrast volume (ml) used during the diagnostic coronary angiography
24 hours
Crossover access site
Time Frame: 24 hours
Need for crossover access site, other than this of randomization
24 hours
Major Cardiovascular Events
Time Frame: 24 hours
Death, stroke, acute myocardial infarction
24 hours
Vascular Complications
Time Frame: 24 hours
Vascular access complications
24 hours

Collaborators and Investigators

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

Sponsor

University Hospital of Patras

Collaborators

AHEPA University Hospital
Korgialenio-Benakio Red Cross Hospital
University General Hospital of Heraklion

Investigators

  • Study Director: George Hahalis, Prof., University Hospital of Patras
  • Study Director: Periklis Davlouros, Ass. Prof., University Hospital of Patras
  • Principal Investigator: Grigorios Tsigkas, University Hospital of Patras
  • Principal Investigator: Athanasios Makris, University Hospital of Patras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 20, 2017

Primary Completion (Actual)

May 15, 2018

Study Completion (Actual)

May 15, 2018

Study Registration Dates

First Submitted

December 31, 2017

First Submitted That Met QC Criteria

January 4, 2018

First Posted (Actual)

January 8, 2018

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 3, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5602

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.

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