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Search / Trial NCT04124120

Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Oct 10, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The clinical trial titled "Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women" is studying how using one or multiple arterial grafts during heart surgery affects women’s health outcomes. Specifically, the researchers want to find out if using multiple arterial grafts (MAG) leads to better results, such as fewer serious heart problems or strokes, compared to using just one graft (SAG). They will include around 2,000 women who need coronary artery bypass surgery, which is a procedure to improve blood flow to the heart. Eligible participants are women aged 18 and older who are having their first heart surgery for significant blockages in their coronary arteries.

If you participate in this trial, you will be randomly assigned to receive either MAG or SAG during your surgery. The study will also look at how these different types of grafting affect your quality of life and overall well-being after the surgery. This means that the researchers will ask about your physical and mental health, as well as any symptoms you may experience. The trial is currently recruiting participants and aims to provide valuable insights that could improve heart surgery outcomes for women in the future.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. Women patients ≥18 years old.
  • 2. Isolated coronary artery bypass grafting.
  • 3. Primary (first time) cardiac surgery procedure.
  • 4. Significant disease of the left main coronary artery or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.
  • Exclusion Criteria:
  • Male gender
  • Single graft
  • Emergency operation
  • Myocardial infarction within 72 hours of surgery
  • Left ventricular ejection fraction \< 35%
  • Any concomitant cardiac or non-cardiac procedure
  • Previous cardiac surgery
  • Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduces life expectancy to less than 5 years.
  • Inability to use the saphenous vein or to use both radial and right internal thoracic arteries
  • Anticipated need for coronary thrombo-endarterectomy
  • Planned hybrid revascularization

About Weill Medical College Of Cornell University

Weill Medical College of Cornell University is a leading academic institution dedicated to advancing medical research and education. As a prominent sponsor of clinical trials, it focuses on innovative healthcare solutions and the development of new therapies across various medical disciplines. The institution is committed to fostering collaborative research efforts that enhance patient care and improve health outcomes. With a robust infrastructure and a team of experienced researchers and clinicians, Weill Cornell aims to translate scientific discoveries into practical applications, ensuring a strong emphasis on ethical standards and regulatory compliance throughout the clinical trial process.

Locations

Ann Arbor, Michigan, United States

Houston, Texas, United States

Columbus, Ohio, United States

Philadelphia, Pennsylvania, United States

Baltimore, Maryland, United States

New York, New York, United States

Chicago, Illinois, United States

Winston Salem, North Carolina, United States

Cleveland, Ohio, United States

Toronto, Ontario, Canada

Iowa City, Iowa, United States

Providence, Rhode Island, United States

Copenhagen, , Denmark

Newark, New Jersey, United States

Sudbury, Ontario, Canada

Los Angeles, California, United States

Winnipeg, Manitoba, Canada

Pomona, California, United States

Pittsburgh, Pennsylvania, United States

Atlanta, Georgia, United States

Salt Lake City, Utah, United States

Durham, North Carolina, United States

Barcelona, , Spain

Omaha, Nebraska, United States

Wynnewood, Pennsylvania, United States

Greenville, North Carolina, United States

Saint Louis, Missouri, United States

Aurora, Colorado, United States

Ottawa, Ontario, Canada

Ridgewood, New Jersey, United States

Hamilton, Ontario, Canada

Zanesville, Ohio, United States

Zagreb, , Croatia

Hartford, Connecticut, United States

Gothenburg, , Sweden

Lincoln, Nebraska, United States

Vienna, , Austria

London, Ontario, Canada

Aalborg, , Denmark

New York, New York, United States

San Francisco, California, United States

London, , United Kingdom

Trier, , Germany

London, , United Kingdom

Edinburgh, , United Kingdom

Erlangen, , Germany

Innsbruck, , Austria

Queens, New York, United States

Montréal, Quebec, Canada

New York, New York, United States

Blackpool, Lancashire, United Kingdom

Toronto, Ontario, Canada

Springfield, Massachusetts, United States

Leiden, Zuid Holland, Netherlands

Middlesbrough, , United Kingdom

Graz, , Austria

Haifa, , Israel

Jena, , Germany

Bari, , Italy

Leicester, , United Kingdom

Roma, , Italy

Florence, , Italy

New Haven, Connecticut, United States

Seoul, , Korea, Republic Of

Brooklyn, New York, United States

Brescia, , Italy

Dallas, Texas, United States

Stoke On Trent, Staffordshire, United Kingdom

San Antonio, Texas, United States

Englewood, New Jersey, United States

Linz, , Austria

Shanghai, Shanghai, China

Sheffield, , United Kingdom

Wolverhampton, , United Kingdom

New York, New York, United States

Singapore, , Singapore

Rotterdam, , Netherlands

Montréal, Quebec, Canada

Katowice, , Poland

Roma, , Italy

Melbourne, , Australia

London, , United Kingdom

Worcester, Massachusetts, United States

Manchester, , United Kingdom

Vienna, , Austria

Porto Alegre, , Brazil

São Paulo, , Brazil

Vila Mariana, , Brazil

Saint John, New Brunswick, Canada

Montréal, Quebec, Canada

Ste Foy, Quebec, Canada

Beijing, Beijing, China

Changchun, Jilin, China

Tianjin, Tianjin, China

Hradec Králové, , Czechia

Nové Město, , Czechia

Bad Krozingen, Baden Wuerttemberg, Germany

Bad Oeynhausen, , Germany

Duisburg, , Germany

Duisburg, , Germany

Düsseldorf, , Germany

Frankfurt, , Germany

Gießen, , Germany

Göttingen, , Germany

Leipzig, , Germany

Stuttgart, , Germany

Coimbatore, Tamil Nadu, India

Hyderabad, Telangana, India

Cotignola, , Italy

Torino, , Italy

Bunkyō Ku, Tokyo, Japan

Saitama, , Japan

Seúl, , Korea, Republic Of

Maastricht, , Netherlands

Zabrze, , Poland

Coimbra, , Portugal

Lisboa, , Portugal

Porto, , Portugal

Belgrade, , Serbia

Elx, Alicante, Spain

Zhongzheng, Taipei, Taiwan

Berlin, , Germany

Montréal, , Canada

New Westminster, , Canada

Skopje, , North Macedonia

Tomsk, , Russian Federation

Madrid, , Spain

Pamplona, , Spain

Hull, , United Kingdom

Royal Oak, Michigan, United States

Omaha, Nebraska, United States

St. John's, Newfoundland And Labrador, Canada

Essen, , Germany

Bergamo, , Italy

Multiple Locations, Oxford, United Kingdom

Clydebank, , United Kingdom

Liverpool, , United Kingdom

Galveston, Texas, United States

Clayton, , Australia

Gdańsk, , Poland

Porto, , Portugal

Stockholm, , Sweden

Cambridge, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Mario Gaudino, Prof/PhD/MD

Principal Investigator

Weill Medical College of Cornell University

Stephen Fremes, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Ruth Masterson Creber, RN, PhD

Principal Investigator

Columbia University

C. Noel Bairey Merz, MD

Principal Investigator

Cedars-Sinai

Karla Ballman, PhD

Principal Investigator

Weill Medical College of Cornell University

Sean O'Brien, PhD

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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