Transit-Time Flow Measurement for Coronary Artery Bypass Surgery
(SMARTFLOW Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to study a tool called Transit-Time Flow Measurement (TTFM) used during coronary artery bypass surgery, a procedure to improve blood flow. TTFM employs sound waves to assess blood flow through vessels during surgery. The trial will compare surgeries using TTFM with those not using it to determine if it helps doctors ensure better blood flow. Suitable participants have previously undergone multivessel coronary artery bypass surgery (CABG) and are not in an emergency situation. As an unphased trial, this study allows participants to contribute to advancing surgical techniques that could improve outcomes for future patients.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this tool is safe for use during coronary artery bypass surgery?
Research has shown that Transit-Time Flow Measurement (TTFM) is a safe tool used during heart bypass surgery. TTFM uses sound waves to monitor blood flow in real-time, helping doctors identify any issues with the grafts during the operation. Studies have found that TTFM can enhance the safety and success of the surgery by ensuring proper blood vessel function. No direct evidence indicates that TTFM harms patients. Its use in surgeries suggests it is generally well-tolerated.12345
Why are researchers excited about this trial?
Researchers are excited about Transit-Time Flow Measurement (TTFM) because it brings a new level of precision to coronary artery bypass surgery. Unlike the standard approach, which often relies on visual assessment and experience to gauge blood flow, TTFM offers real-time measurements of blood flow through the grafts during surgery. This method could potentially reduce complications by ensuring that the bypass is functioning optimally before the surgery is completed. By providing immediate feedback, TTFM aims to improve surgical outcomes and enhance patient safety.
What evidence suggests that Transit-Time Flow Measurement is effective for coronary artery bypass surgery?
This trial will compare the use of Transit-Time Flow Measurement (TTFM) during coronary artery bypass surgery with surgeries that do not use TTFM. Studies have shown that TTFM helps check blood flow during heart bypass surgery. It identifies issues with the grafts during the operation, preventing problems later. Research indicates that TTFM can lead to better patient outcomes, such as keeping the grafts open for at least a year. It can also lower the risk of major heart issues after surgery. Overall, TTFM serves as a valuable tool for improving the success of heart surgeries.12567
Who Is on the Research Team?
Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC
Principal Investigator
Weill Medical College of Cornell University
Are You a Good Fit for This Trial?
This trial is for adults over 18 who are having their first planned (not emergency) multi-vessel heart bypass surgery through the chest and can give consent and complete study questionnaires.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo coronary artery bypass grafting (CABG) with or without the use of Transit-Time Flow Measurement (TTFM)
Follow-up
Participants are monitored for graft patency and major adverse cardiac events (MACE)
Long-term Follow-up
Participants are monitored for major adverse cardiac events (MACE) and quality of life using the Seattle Angina Questionnaire
What Are the Treatments Tested in This Trial?
Interventions
- Transit-Time Flow Measurement (TTFM)
Trial Overview
The study is testing a tool called Transit-Time Flow Measurement (TTFM), which uses sound waves during heart bypass surgery to check blood flow in grafts. Researchers want to see if TTFM readings relate to how well the graft stays open and patient recovery.
How Is the Trial Designed?
2
Treatment groups
Active Control
Use of TTFM during surgery
No TTFM during surgery
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
Medistim ASA
Industry Sponsor
Citations
Transit time flow measurement and outcome in coronary artery ...
Transit time flow measurement (TTFM) is useful in detecting intraoperative graft failures during coronary artery bypass grafting (CABG).
The Use of Intraoperative Transit Time Flow Measurement ...
Transit time flow measurement (TTFM) allows quality control in coronary artery bypass grafting but remains largely underused.
Coronary Artery Bypass Grafting Transit Time Flow ...
Comparative patient outcomes based on TTFM use included 1-year graft patency and 1-year and 5-year major adverse cardiac events: all-cause ...
Transit-Time Flow Measurement and Outcomes in ...
This study aimed to investigate whether TTFM values were predictive of graft failure and major adverse cardiac and cerebrovascular events (MACCEs).
Graft flow evaluation with intraoperative transit-time ...
We aimed to compare transit-time flow measurement (TTFM) parameters for on-pump (ONCAB) and off-pump (OPCAB) coronary artery bypass procedures.
6646 Transit Time Flow measurement in coronary surgery. ...
Transit-time flowmetry (TTFM) allows grafts quality control during coronary artery bypass surgery by measuring the flow volume through them.
Transit-Time Flow Measurement and Outcomes in ...
A high pulsatility index in transit time flow measurements predicts graft failure and poor clinical outcomes for sequential venous grafts after surgery.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.