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NCT Number: NCT06471062

Transit Time Flow Measurement in Coronary Surgery

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Bypass Graft Stenosis Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. LIMA>LAD Pulsatility index (PI) modification

    Time frame: During the surgery, out of cardiopulmonary bypass

    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

Secondary outcomes

  1. LIMA>LAD mean flow change

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

    under rest conditions and after pharmacological stress. The unit of measure will be ml/min. The average flow should be above 20 ml/min.

  2. LIMA>LAD Diastolic filling (%DF) change

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

    under rest conditions and after pharmacological stress. The unit of measure will be the ratio between two parameters expressed by ml/min.

  3. variation of Diastolic filling (%DF) on the right coronary

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

    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%.

  4. LIMA>LAD % Backward flow (BF) change

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

    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.

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

cammertoni federico

CONTACT

[email protected]

+393292060538

serena davino

CONTACT

[email protected]

+393315618724

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: COLLATERAL

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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