An observational study in Coronary Artery Disease, Coronary Stenosis and Coronary Bypass Graft Stenosis, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 135 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
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
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — Patient data (personal data, anthropometric data, cardiovascular risk factors, co-patologies, cardiac history, blood tests, drug therapy, electrocardiogram, echocardiogram, angiography) will be recorded
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS