Clinical trial NCT06471062: Transit Time Flow Measurement in Coronary Surgery
Official title: Transit Time Flow Measurement in Coronary Surgery: The Mutual Influence of Collateral Flow Between Different Coronary Territories on Parameter Metrics
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Artery Disease
Coronary Stenosis
Coronary Bypass Graft Stenosis
Keywords: coronary artery bypass
Transit Time Flowmetry
Intraoperative epicardial high-frequency ultrasound (HFUS)
Coronary anastomosis patency
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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;
* patients undergoing single aortocoronary bypass surgery

Primary outcomes:
measure: LIMA>LAD Pulsatility index (PI) modification
timeFrame: During the surgery, out of cardiopulmonary bypass
Secondary outcomes:
measure: LIMA>LAD mean flow change
timeFrame: During surgery, before and after transient occlusion of the other grafts for non-LAD coronary targets
measure: LIMA>LAD Diastolic filling (%DF) change
timeFrame: During surgery,before and after transient occlusion of the other grafts for non-LAD coronary targets.
measure: variation of Diastolic filling (%DF) on the right coronary
timeFrame: During surgery,before and after transient occlusion of the other grafts for non-LAD coronary targets.
measure: LIMA>LAD % Backward flow (BF) change
timeFrame: During surgery, before and after transient occlusion of the other grafts for non-LAD coronary targets.
measure: mean flow, Pulsatility Index, Diastolic filling (%DF) and Diastolic filling (%DF) in the non-LAD grafts
timeFrame: During surgery, before and after transient occlusion of the LIMA>LAD graft
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Gemelli IRCCS
name: federico cammertoni
role: PRINCIPAL_INVESTIGATOR
References: