Trial comparing treatments for Heart Diseases
Official title Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
ClinicalTrials.gov ID: NCT04124120
What this study is testing
- What it's testing
- The study will compare the rates of serious heart and brain events and quality of life between the two grafting strategies.
- Who it's for
- Women who are scheduled for coronary artery bypass grafting and meet the study’s eligibility criteria.
- What's involved
- Participants will be randomly assigned to receive either a single arterial graft or multiple arterial grafts during surgery, and will complete questionnaires about their health and quality of life.
- Time commitment
- The study lasts until the patient’s follow‑up visits after surgery, with a total of about 2,300 women enrolled and 500 completing quality‑of‑life assessments.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Women patients ≥18 years old.
- Isolated coronary artery bypass grafting.
- Primary (first time) cardiac surgery procedure.
- Significant disease of the left main coronary artery or of the left anterior descending and the circumflex coronary system with or without disease of...
You likely can't join if
- 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
See the full eligibility criteria
- Women patients ≥18 years old.
- Isolated coronary artery bypass grafting.
- Primary (first time) cardiac surgery procedure.
- 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Pomona, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Baltimore, Maryland, United States
- Springfield, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Royal Oak, Michigan, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Englewood, New Jersey, United States
- Newark, New Jersey, United States
- Ridgewood, New Jersey, United States
- Brooklyn, New York, United States
+ 87 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Pomona, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; Hartford, Connecticut, United States; New Haven, Connecticut, United States and 101 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.