Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 9:02 AM
Study NCT ID:
NCT00286559
Status:
WITHDRAWN
Last Update Posted:
2015-03-25
First Post:
2006-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Myocardial Blood Flow and Blood Flow Reserve by Transoesophageal Echocardiography (TEE)
Sponsor:
University Hospital, Basel, Switzerland
Organization:
Study Overview
Official Title:
Feasibility and Accuracy of Transoesophageal Harmonic Contrast Echocardiography in Assessing Myocardial Blood Flow and Blood Flow Reserve
Status:
WITHDRAWN
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
echo contrast agents no longer allowed in CAD patients.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Until today it was not possible to reliably assess the function of a new bypass, i.e., to measure myocardial perfusion. Measuring intramyocardial blood flow directly after revascularisation would greatly improve the assessment of graft function. With transthoracic contrast echocardiography, myocardial perfusion can be reliably assessed, as it has been shown in numerous studies. In the first part of the study the investigators will clarify methodological aspects of contrast echocardiography. In the second part they will analyze the validity of contrast TEE in the operating room.
Detailed Description:
Until today it was not possible to reliably assess the function of a new bypass, i.e., to measure myocardial perfusion. Measuring intramyocardial blood flow directly after revascularisation would greatly improve the assessment of graft function. With transthoracic contrast echocardiography myocardial perfusion can be reliably assessed, as it has been shown in numerous studies.
As there is a new transoesophageal ultrasound probe on the market which allows contrast imaging, we would like to establish contrast echocardiography in the operating room in patients undergoing CABG surgery.
Ultrasound contrast agents (e.g., SonoVue®, Optison®) consist of gas filled microspheres surrounded by a stabilizing coat. They are smaller than red blood cells and similar to blood in their rheological habit. The microspheres are injected into a peripheral or central vein. They pass lung circulation and disperse into the left heart, coronary arteries and body circulation. A few minutes after administration the low-soluble gas of the microspheres is exhaled. The interaction of the ultrasound beam with microspheres leads to oscillation of the microspheres and thereby amplification of the ultrasound signal. This technique allows enhancement of endocardial border but also visualization of myocardial perfusion and assessment of myocardial blood flow reserve. The latter requires measurement of myocardial perfusion a first time at rest and a second time during hyperemia with adenosine. The quotient of both gives myocardial flow reserve. This parameter is of paramount importance in cardiology to detect coronary artery stenosis and reduced coronary or myocardial flow reserve quantitatively.
The contrast agents as well as adenosine (a natural purine nucleoside, which can be found in all cells of the body) have a good safety profile with harmless and transient side effects. Our patients will be under anesthesia and therefore feel none of those side effects.
The study will be spread into two parts. In a first part we will clarify methodological aspects of contrast echocardiography: two different contrast agents and three different contrast imaging methods will be evaluated. One imaging method and one contrast agent will be chosen for the second part. In the second part we will analyze the validity of contrast TEE in the operating room. In addition correlation of changes in myocardial blood flow after coronary artery bypass graft (CABG) surgery and improvement in myocardial perfusion as well as global and regional function in follow-up SPECT (Single Photon Emission Computed Tomography) and transthoracic echocardiography, respectively will be evaluated. By means of these data we possibly will be able to predict success of revascularisation at the end of surgery.
As there is a new transoesophageal ultrasound probe on the market which allows contrast imaging, we would like to establish contrast echocardiography in the operating room in patients undergoing CABG surgery.
Ultrasound contrast agents (e.g., SonoVue®, Optison®) consist of gas filled microspheres surrounded by a stabilizing coat. They are smaller than red blood cells and similar to blood in their rheological habit. The microspheres are injected into a peripheral or central vein. They pass lung circulation and disperse into the left heart, coronary arteries and body circulation. A few minutes after administration the low-soluble gas of the microspheres is exhaled. The interaction of the ultrasound beam with microspheres leads to oscillation of the microspheres and thereby amplification of the ultrasound signal. This technique allows enhancement of endocardial border but also visualization of myocardial perfusion and assessment of myocardial blood flow reserve. The latter requires measurement of myocardial perfusion a first time at rest and a second time during hyperemia with adenosine. The quotient of both gives myocardial flow reserve. This parameter is of paramount importance in cardiology to detect coronary artery stenosis and reduced coronary or myocardial flow reserve quantitatively.
The contrast agents as well as adenosine (a natural purine nucleoside, which can be found in all cells of the body) have a good safety profile with harmless and transient side effects. Our patients will be under anesthesia and therefore feel none of those side effects.
The study will be spread into two parts. In a first part we will clarify methodological aspects of contrast echocardiography: two different contrast agents and three different contrast imaging methods will be evaluated. One imaging method and one contrast agent will be chosen for the second part. In the second part we will analyze the validity of contrast TEE in the operating room. In addition correlation of changes in myocardial blood flow after coronary artery bypass graft (CABG) surgery and improvement in myocardial perfusion as well as global and regional function in follow-up SPECT (Single Photon Emission Computed Tomography) and transthoracic echocardiography, respectively will be evaluated. By means of these data we possibly will be able to predict success of revascularisation at the end of surgery.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: