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Completed

NCT Number: NCT03393052

Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Patras

Pátrai, Achaia, 26504, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Coronary Angiography

Procedure

Comparison of left radial versus femoral access during coronary angiography of patients who have undergone coronary artery bypass grafting surgery

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Dose Area Product

    Time frame: 24 hours

    Radiation DAP (mGy*cm2) during the diagnostic coronary angiography

  4. Contrast Volume

    Time frame: 24 hours

    Contrast volume (ml) used during the diagnostic coronary angiography

  5. Crossover access site

    Time frame: 24 hours

    Need for crossover access site, other than this of randomization

  6. Major Cardiovascular Events

    Time frame: 24 hours

    Death, stroke, acute myocardial infarction

  7. Vascular Complications

    Time frame: 24 hours

    Vascular access complications

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Collaborators

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

Registry information

Acronym: L-RECORD

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 8, 2018
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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