One-year comparison of radial artery versus no-touch saphenous vein grafts in women having coronary bypass surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized comparison enrolling women having primary isolated coronary artery bypass grafting with three-vessel disease to receive either a radial artery graft or a saphenous vein graft harvested with a no-touch technique to the second-best coronary target. Eligible participants have left ventricular ejection fraction over 35% and target vessels of at least 1.5 mm with ≥70% proximal stenosis. Patients are randomized at the time of surgery and followed for graft patency at one year using clinical follow-up and imaging. The primary outcome is one-year graft patency in the treated target vessel territory.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Women aged 18 years or older and younger than 75 years, undergoing isolated and primary myocardial revascularization surgery, with triarterial coronary artery disease (three vessels involved) in vessels subject to surgical revascularization and left ventricular ejection fraction greater than 35%. The target coronary vessels of the study will be those in the territory of the left circumflex artery and the right coronary artery, which must have at least 1.5 mm in diameter, and with proximal obstructive lesions of at least 70%.

Exclusion Criteria:

1. Preoperative conditions:

   1. Lack of the patient's written informed consent.
   2. Presence of poorly controlled diabetes, with a glycated hemoglobin value \>8 mg/dl.
   3. Emergency or salvage surgery, where the intervention needs to be performed quickly due to the critical clinical condition of the patient.
   4. Renal failure with glomerular filtration rate (creatinine clearance) \<30 mL/min.
2. Inability to use the saphenous and/or radial vein

   1. Positive Allen test using a pulse oximeter
   2. Presence of abnormal flow detected by means of a Doppler exam in one of the grafts to be used.
   3. History of vasculitis or Raynaud's syndrome, varicose veins, or history of previous saphenous vein removal
3. Conditions that may affect patient follow-up

   1. Presence of advanced peripheral arterial disease
   2. Known contrast allergy: Presence of a documented allergy to the contrast agent used in radiological procedures.
   3. Impossibility of tracking due to geographic inaccessibility.
   4. Patients with lack of adherence to guidelines and/or prescribed medications.

Where it's running

• Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Omar AV Mejia, MD, PhD — InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
• Study coordinator: Omar A V Mejia, MD, PhD
• Email: omarvmejia@incor.usp.br
• Phone: +551126615014

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remote Balance in Everyday Life for young MI patients with distress

  This study tests a remote 6-session program (rBEL) to help adults under 55 who had a heart attack and feel distressed see if the program and study procedures are feasible.

  Recruiting Uppsala University · Uppsala · NCT07706816

• Well-being program for caregivers of patients with advanced heart or lung disease

  This study tests an 8-week, home-based wellness program delivered virtually to caregivers of people with advanced cardiac or pulmonary disease to see if it’s feasible and acceptable.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT07685912

• Differences in Outcomes After Allograft vs Autograft in Revision ACL Repair

  This study looks at whether using donor tissue (allograft) versus the patient’s own tissue (autograft) in revision ACL surgery leads to different results.

  Recruiting Istituto Ortopedico Rizzoli · Bologna, Bologna · NCT07671235

• Does preoperative physical activity help predict perioperative problems after non-cardiac surgery?

  This study tests whether self-reported physical activity before surgery adds to existing risk factors in predicting complications and death after elective non-cardiac surgery.

  Recruiting Karolinska Institutet · Stockholm · NCT07603622

• Digital diagnosis of newborn heart sounds

  This project will test a digital, machine-learning tool that listens to newborn heart sounds to try to detect serious congenital heart problems in the first month of life.

  Recruiting at 4 sites IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna, BO and 4 other locations · NCT07542509

• Efferon LPS hemoadsorption during and after heart surgery

  This trial tests whether using the Efferon® LPS filter during cardiopulmonary bypass and again within 24 hours afterward can lower the chance and severity of multiple organ dysfunction in adults having cardiac surgery who are at higher surgical risk.

  Recruiting at 3 sites Efferon JSC · Barnaul and 2 other locations · NCT07532174

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.