Transit Time Flow Measurement in Coronary Surgery

N/ANot Yet RecruitingNCT06471062

Fondazione Policlinico Universitario Agostino Gemelli IRCCS135 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

135

Conditions

Coronary Artery Disease Coronary Stenosis Coronary Bypass Graft Stenosis

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 bypass

Secondary Outcomes

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 targets

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.

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.

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.

mean flow, Pulsatility Index, Diastolic filling (%DF) and Diastolic filling (%DF) in the non-LAD grafts

under rest conditions and after pharmacological stress. The meaf low will be measured in "ml/min". The others will be expressed by the ratio between two parameters expressed by ml/min.

Time frame: During surgery, before and after transient occlusion of the LIMA>LAD graft