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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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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| cammertoni federico | Contact | +393292060538 | federico.cammertoni@policlinicogemelli.it | |
| serena davino | Contact | +393315618724 | serena.davino@guest.policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| federico cammertoni | Fondazione Policlinico Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Gemelli IRCCS | Roma | Italy |
Patient data (personal data, anthropometric data, cardiovascular risk factors, co-patologies, cardiac history, blood tests, drug therapy, electrocardiogram, echocardiogram, angiography) will be recorded
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2024 | Jun 10, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 16, 2024 | Jun 10, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |