Blood Flow, CABG, CABG Graft Integrity, Heart Disease, Transit-time Flow Measurement
Conditions
Keywords
SMARTFLOW
Brief summary
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
Detailed 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.
Interventions
DEVICETransit-Time Flow Measurement (TTFM)
TTFM is based on ultrasound technology and allows the assessment of intraoperative graft function based on quantification, directionality and resistance to blood flow through the graft.
Sponsors
Weill Medical College of Cornell University
Medistim ASA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
SMARTFLOW:Patency is an expertise-based, double-blind, multicenter, 1:1 randomized clinical trial. The trial will compare use of TTFM versus non-use of TTFM for reduction of graft failure in patients undergoing CABG.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>18 years 2. First-time, non-emergent isolated multivessel CABG through median sternotomy 3. Willing and able to provide written informed consent and comply with all study procedures, including QOL questionnaires
Exclusion criteria
1. Reoperation 2. Emergency procedures 3. Combined CABG + other cardiac or non-cardiac surgery 4. Isolated single vessel CABG 5. Minimally invasive CABG 6. Inability to undergo coronary computed tomographic angiography (CCTA) 7. Unable to provide written informed consent or comply with all the study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any Graft Failure | 1 to 3 months after index CABG | The primary outcome of SMARTFLOW:Patency is any graft failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to the occurrence of major adverse cardiac event (MACE) | Within 10 years of randomization | Time to the occurrence of major adverse cardiac event (MACE), defined as the composite of death, myocardial infarction or target vessel revascularization |
| Time-averaged change from baseline in Seattle Angina Questionnaire. | Within 10 years of randomization | The Seattle Angina Questionnaire (SAQ) is a validated 19-item self-administered survey used to measure the functional status and quality of life in patients with coronary artery disease |
Countries
United States
Contacts
CONTACTSMARTFLOW Trial Listserv
PRINCIPAL_INVESTIGATORMario Gaudino, MD, PhD, MSCE, FEBCTS, FACC
Weill Medical College of Cornell University
Outcome results
None listed