Transit Time Flow Measurement in Coronary Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
Transit-time flowmetry (TTFM) allows grafts quality control during coronary artery bypass surgery by measuring the flow volume through them.
To date, many studies have deeply studied the predictive role on the graft outcomes of the various flowmetry-derived parameters. One of the least investigated aspects, however, is the mutual influence that two newly realized grafts can have. This possibility would be related to the presence of a more or less developed collateral circulation between the bypassed territories.
The purpose of this study is to assess whether a graft for a territory different than that provided by the left anterior descending artery (LAD) may affect the functionality (measured through flowmetry) of the left internal mammary artery - LAD graft.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age > 18 years;
informed consent acquired and registered;
patients who undergo coronary artery bypass grafting (with or without cardiopulmonary bypass);
patients with stable angina, unstable angina or acute coronary syndrome without elevation of the ST tract (NSTEMI)
Disqualifiers
patients unable to give informed consent;
patients undergoing emergency surgery;
patients in unstable haemodynamic conditions or in need of pharmacological or mechanical support;
patients undergoing combined surgery;
Trial population
All patients with coronary artery disease and an indication for surgical revascularization (coronary artery bypass grafting) who meet the above-described inclusion and exclusion criteria will be enrolled by signing the informed consent the day before surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
LIMA>LAD Pulsatility index (PI) modification
The primary aim of this study is to assess whether a graft for a non-LAD coronary target modifies the performance (measured by flowmetry) of the flow in the LIMA\>LAD graft. PI is expressed by the ratio of the flow volume amplitude and mean flow volume, both quantified by a flowmeter (ml/min / ml/min). An ideal value would be \< 3
Time frame
During the surgery, out of cardiopulmonary bypassSecondary outcomes
1
LIMA>LAD mean flow change
under rest conditions and after pharmacological stress. The unit of measure will be ml/min. The average flow should be above 20 ml/min.
Time frame
During surgery, before and after transient occlusion of the other grafts for non-LAD coronary targets2
LIMA>LAD Diastolic filling (%DF) change
under rest conditions and after pharmacological stress. The unit of measure will be the ratio between two parameters expressed by ml/min.
Time frame
During surgery,before and after transient occlusion of the other grafts for non-LAD coronary targets.3
variation of Diastolic filling (%DF) on the right coronary
depending on its dominance or hyperdominance. The unit of measure will be the ratio between two parameters expressed by ml/min. DF% is accepted around 50%.
Time frame
During surgery,before and after transient occlusion of the other grafts for non-LAD coronary targets.4
LIMA>LAD % Backward flow (BF) change
under rest conditions and after pharmacological stress. The unit of measure will be the ratio between two parameters expressed by ml/min. The identified cut-off is 3% of the total flow.
Time frame
During surgery, before and after transient occlusion of the other grafts for non-LAD coronary targets.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: