The Relationship Between Blood Flow Readings During Surgery and How Well the Graft Stays Open and How Patients Recover Afterward in Coronary Artery Bypass Graft Surgery (SMARTFLOW)
Status
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to learn more about a tool called Transit-Time Flow Measurement (TTFM). TTFM uses sound waves during surgery to check how well blood is flowing through blood vessels. This helps doctors see if the blood flow is good during coronary artery bypass grafting (CABG), which is a type of heart surgery
Full description
The SMARTFLOW:Patency trial is designed to fill this critical evidence gap by evaluating the impact of CABG graft quality assessment by TTFM on clinical outcomes in a large randomized cohort. SMARTFLOW:Patency will evaluate the impact of CABG graft quality assessment by TTFM on graft patency.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Age >18 years
- First-time, non-emergent isolated multivessel CABG through median sternotomy
- Willing and able to provide written informed consent and comply with all study procedures, including QOL questionnaires
Exclusion criteria
- Reoperation
- Emergency procedures
- Combined CABG + other cardiac or non-cardiac surgery
- Isolated single vessel CABG
- Minimally invasive CABG
- Inability to undergo coronary computed tomographic angiography (CCTA)
- Unable to provide written informed consent or comply with all the study procedures.
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,242 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
SMARTFLOW Trial Listserv
Data sourced from clinicaltrials.gov
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