Coronary Artery DiseaseCOLLATERALNCT06471062
Transit Time Flow Measurement in Coronary Surgery
An observational study of Coronary Artery Disease and Coronary Stenosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Coronary Stenosis, Coronary Bypass Graft Stenosis
- How many people
- 135 participants
- Where
- 1 siteItaly
- Study dates
- 20 Nov 2024to 20 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Gemelli IRCCS
Roma
cammertoni federico, +393292060538, federico.cammertoni@policlinicogemelli.it
serena d'avino, +393315618724, serena.davino@guest.policlinicogemelli.it
About this study
Official title: 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.
- Keywords
- coronary artery bypass, Transit Time Flowmetry, Intraoperative epicardial high-frequency ultrasound (HFUS), Coronary anastomosis patency
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the surgery, out of cardiopulmonary bypass
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: During surgery, before and after transient occlusion of the LIMA>LAD graft
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start20 Nov 2024 (estimated)
- Primary completion20 May 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Cammertoni, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- federico cammertoni, Principal investigator, Fondazione Policlinico Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471062
- Sponsor's protocol ID
- 6646
- Acronym
- COLLATERAL
- Status last verified
- Nov 2024
- First submitted
- 28 May 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Patient data (personal data, anthropometric data, cardiovascular risk factors, co-patologies, cardiac history, blood tests, drug therapy, electrocardiogram, echocardiogram, angiography) will be recorded
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transit Time Flow Measurement in Coronary Surgery: The Mutual Influence of Collateral Flow Between Different Coronary Territories on Parameter Metrics
- ClinicalTrials.gov ID
- NCT06471062
- Acronym / sponsor ID
- COLLATERAL / 6646
- Keywords
- coronary artery bypass, Transit Time Flowmetry, Intraoperative epicardial high-frequency ultrasound (HFUS), Coronary anastomosis patency
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
LIMA>LAD mean flow change
Time frame: During surgery, before and after transient occlusion of the other grafts for non-LAD coronary targets
LIMA>LAD Diastolic filling (%DF) change
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
Time frame: During surgery,before and after transient occlusion of the other grafts for non-LAD coronary targets.
LIMA>LAD % Backward flow (BF) change
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
Time frame: During surgery, before and after transient occlusion of the LIMA>LAD graft
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: Undecided. Patient data (personal data, anthropometric data, cardiovascular risk factors, co-patologies, cardiac history, blood tests, drug therapy, electrocardiogram, echocardiogram, angiography) will be recorded
Related trials for Coronary Artery Disease
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
federico cammertoni principal investigator
Fondazione Policlinico Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Stenosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact cammertoni federico (+393292060538, federico.cammertoni@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LIMA>LAD Pulsatility index (PI) modification (time frame: During the surgery, out of cardiopulmonary bypass). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.