Transit Time Flow Measurement in Coronary Surgery

NCT06471062 | Not Yet Recruiting

• 1 other identifier: 6646
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

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

  During the surgery, out of cardiopulmonary bypass

Secondary Outcomes (5)

• LIMA>LAD mean flow change

  During surgery, before and after transient occlusion of the other grafts for non-LAD coronary targets

• LIMA>LAD Diastolic filling (%DF) change

  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

  During surgery,before and after transient occlusion of the other grafts for non-LAD coronary targets.

• LIMA>LAD % Backward flow (BF) change

  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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Roma, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• federico cammertoni

  Fondazione Policlinico Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

cammertoni federico

CONTACT

+393292060538; federico.cammertoni@policlinicogemelli.it

serena davino

CONTACT

+393315618724; serena.davino@guest.policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 24, 2024
• Study Start: November 20, 2024
• Primary Completion: May 20, 2025
• Study Completion: October 20, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

IT (1)