Transit Time Flow Measurement in Coronary Surgery (COLLATERAL)

Transit Time Flow Measurement in Coronary Surgery: The Mutual Influence of Collateral Flow Between Different Coronary Territories on Parameter Metrics

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 Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Coronary Stenosis; Coronary Bypass Graft Stenosis

• Study Type: Observational
• Enrollment (Estimated): 135

Contacts and Locations

• Study Contact: Name: cammertoni federico; Phone Number: +393292060538; Email: federico.cammertoni@policlinicogemelli.it
• Study Contact Backup: Name: serena davino; Phone Number: +393315618724; Email: serena.davino@guest.policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy
    • Fondazione Policlinico Gemelli IRCCS
    • Contact: cammertoni federico; Phone Number: +393292060538; Email: federico.cammertoni@policlinicogemelli.it
    • Contact: serena d'avino; Phone Number: +393315618724; Email: serena.davino@guest.policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During the surgery, out of cardiopulmonary bypass

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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%.	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.	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.	During surgery, before and after transient occlusion of the LIMA>LAD graft

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: federico cammertoni, Fondazione Policlinico Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): November 20, 2024
• Primary Completion (Estimated): May 20, 2025
• Study Completion (Estimated): October 20, 2025

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: coronary artery bypass; Transit Time Flowmetry; Intraoperative epicardial high-frequency ultrasound (HFUS); Coronary anastomosis patency
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Constriction, Pathologic; Coronary Artery Disease; Coronary Stenosis
• Other Study ID Numbers: 6646

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Patient data (personal data, anthropometric data, cardiovascular risk factors, co-patologies, cardiac history, blood tests, drug therapy, electrocardiogram, echocardiogram, angiography) will be recorded

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No